PULsecath mechanicaL Support Evaluation (PULSE)

March 24, 2021 updated by: Nicolas van Mieghem, Erasmus Medical Center

PULsecath mechanicaL Support Evaluation (PULSE) - Trial

The objective of this study is to determine ventricular loading conditions during and after PulseCath® iVAC2L support, and assess its impact on specific load dependent humoral factors and cardiac enzymes. These specific patterns are so far unknown and will be evaluated invasively.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a mechanistic exploratory study. The objective is to determine the effects of the new PFLVAD PulseCath® iVAC2L on ventricular loading using left ventricular pressure-volume loops, in association with systemic and pulmonary hemodynamic parameters obtained from right and left catheterization. Additionally, assessments of specific load and flow-dependent humoral factors and cardiac enzymes will be made during and after the use of mechanical circulatory support. These specific patterns are so far unknown. Knowledge of optimal patterns may help in determining the ideal circulatory device platform.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France
        • Clinic Pasteur
  • Netherlands
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015CE
        • Erasmus Medical Center
  • United Kingdom
      • London, United Kingdom
        • Kings College London, St. Thomas' Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient is ≥ 18 years;
  2. Informed Consent must be signed by the patient, prior to HR-PCI;
  3. The multidisciplinary heart team has reached consensus for high-risk PCI. Patients may present with left ventricular systolic dysfunction (ejection fraction ≤40%);
  4. Anatomical criteria: Intervention to an unprotected left main coronary artery, left main equivalent or single remaining vessel; multivessel disease; intervention in a distal left main bifurcation.

Exclusion Criteria:

  1. No written informed consent;
  2. Left ventricular thrombus;
  3. Interventricular septal defect;
  4. Significant peripheral arterial disease or arterial lumen size < 6mm at the level of the common femoral artery;
  5. Significant aortic valve disease (more than mild aortic stenosis/regurgitation);
  6. Cardiogenic shock;
  7. Previous stroke within the last 3 months;
  8. Major bleeding event within last 3 months;
  9. Chronic kidney disease with a GFR < 25 mL/min;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: iVAC2L pVAD
Clinically indicated ventricular support for high-risk PCI with Pulsecath iVAC2L.
Device: iVAC2L pVAD
To determine the effects of the new PFLVAD PulseCath® iVAC2L on ventricular loading using left ventricular pressure-volume loops, in association with systemic and pulmonary hemodynamic parameters obtained from right and left catheterization. Additionally, assessments of specific load and flow-dependent humoral factors, and cardiac enzymes, will be made during and after the use of mechanical circulatory support.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Pressure-volume Area (PVA)
Time Frame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Numerical continuous variable representing the change in Myocardial Oxygen Consumption (MVO2) following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in PVA will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.mL
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Cardiac Output
Time Frame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Numerical continuous variable representing the change in Cardiac Output (CO), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in CO will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: L/min
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Change on the Mean Pulmonary Capillary Wedge Pressure
Time Frame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Numerical continuous variable representing the change in Mean Pulmonary Capillary Wedge Pressure (mPCWP), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in mPCWP will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Change in the PCWP v-wave
Time Frame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Numerical continuous variable representing the change in PCWP v-wave (vPCWP), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in vPCWP will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Change in Mean Pulmonary Artery Pressure
Time Frame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Numerical continuous variable representing the change in Mean Pulmonary Artery Pressure (mPAP), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in mPAP will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Change in Pulmonary Artery Oxygen Saturation
Time Frame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Numerical continuous variable representing the change in Pulmonary Artery Oxygen Saturation, also known as Mixed Oxygen Saturation (SVO2), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in SVO2 will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: %
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Change in Right Atrial Pressure
Time Frame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Numerical continuous variable representing the change in Right Atrial Pressure (RAP), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in RAP will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Change in Preload-recruitable Stroke Work
Time Frame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Numerical continuous variable representing the change in Preload-recruitable Stroke Work (PRSW), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in PRSW will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Change in the Starling Contractile Index
Time Frame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Numerical continuous variable representing the change in the Starling Contractile Index (SCI), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in SCI will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg/ml⋅s
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Change in End-systolic Wall Stress
Time Frame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Numerical continuous variable representing the change in the End-systolic Wall Stress (WSes), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in WSes will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg.
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Change in the first derivative of pressure over time
Time Frame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Numerical continuous variable representing the change in the first derivative of pressure over time (+dP/dtmax), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in +dP/dtmax will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: mmHg/s
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Change in Systemic Vascular Resistance
Time Frame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Numerical continuous variable representing the change in the Systemic Vascular Resistance (SVR), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in SVR will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: (dyn∙s)/(cm^(-5))
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Change in Pulmonary Vascular Resistance
Time Frame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Numerical continuous variable representing the change in the Pulmonary Vascular Resistance (PVR), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in PVR will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: (dyn∙s)/(cm^(-5))
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Change in Cardiac Power Output
Time Frame: From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Numerical continuous variable representing the change in the Cardiac Power Output (CPO), following ventricular unloading. The PULSE trial will measure in real-time how discrepant this measurement can be when resulting from continuous or pulsatile flow ventricular assist devices. This is not a time-to-event outcome: the change in CPO will be obtained from real-time data collected during the intervention. The time frame will be the time of the Intervention. Unit: Watts
From the beginning of the PCI until its conclusion. This period can be variable and is estimated in 40 to 270 minutes.
Change in Hematocrit
Time Frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Numerical continuous variable. Change in Hematocrit (Ht) as an indicative of bleeding or hemolysis. Unit: %
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in Hemoglobin
Time Frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Numerical continuous variable. Change in Hemoglobin (Hb) as an indicative of bleeding or hemolysis. Unit: mmol/L
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in Platelet Count
Time Frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Numerical continuous variable. Change in Platelet Count as an indicative of bleeding events. Unit: 10^9/L
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in haptoglobin
Time Frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Numerical continuous variable. Change in haptoglobin as an indicative of hemolytic events. Unit: g/L
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in total and conjugated bilirubin
Time Frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Numerical continuous variable. Change in total and conjugated bilirubin as an indicative of hemolytic events. Unit: umol/L
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in lactate dehydrogenase
Time Frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Numerical continuous variable. Change in lactate dehydrogenase as an indicative of hemolytic events. Unit: U/L.
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in hs-troponin
Time Frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Numerical continuous variable. Change in hs-troponin as an indicative of myocardial necrosis. Unit: ng/L
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in creatinephosphokinase
Time Frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Numerical continuous variable. Change in creatinephosphokinase (CK) as an indicative of myocardial necrosis. Unit: U/L
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in creatinophosphokinase MB mass assay
Time Frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Numerical continuous variable. Change in creatinophosphokinase MB mass assay (CKMB-mass) as an indicative of myocardial necrosis. Unit: ug/L
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in N-terminal pro b-type natriuretic peptide
Time Frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Numerical continuous variable. Change in N-terminal pro b-type natriuretic peptide (NT-proBNP) as an indicative of chamber overload. Unit: pmol/L
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in serum lactate
Time Frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Numerical continuous variable. Change in serum lactate as an indicative of hypoperfusion states. Unit: mmol/L.
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Change in serum creatinine
Time Frame: From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
Numerical continuous variable. Change in serum creatinine as an indicative of acute kidney injury. Unit: umol/L
From baseline (beginning of PCI) to immediately after the procedure and 12 hours after PCI.
All-cause mortality
Time Frame: 30 days follow up
Constitutes one of the components of the MACCE composite endpoint: all-cause mortality, acute myocardial infarction, stroke or transient ischemic attack (TIA), and repeat revascularization (PCI or CABG). Time-to-event variable, measured in days.
30 days follow up
Acute myocardial infarction
Time Frame: 30 days follow up
According to the "Fourth Universal Definition of Acute Myocardial Infarction". Constitutes one of the components of the MACCE composite endpoint: all-cause mortality, acute myocardial infarction, stroke or transient ischemic attack (TIA), and repeat revascularization (PCI or CABG). Time-to-event variable, measured in days.
30 days follow up
Stroke or transient ischemic attack
Time Frame: 30 days follow up
As per VARC 2 definitions 2013 J Thorac Cardiovasc Surg 2013;145:6-23. Constitutes one of the components of the MACCE composite endpoint: all-cause mortality, acute myocardial infarction, stroke or transient ischemic attack (TIA), and repeat revascularization (PCI or CABG). Time-to-event variable, measured in days.
30 days follow up
Repeat revascularization
Time Frame: 30 days follow up
As per ARC definition - Circulation. 2007;115:2344-2351. Constitutes one of the components of the MACCE composite endpoint: all-cause mortality, acute myocardial infarction, stroke or transient ischemic attack (TIA), and repeat revascularization (PCI or CABG). Time-to-event variable, measured in days.
30 days follow up
Major Bleeding
Time Frame: 30 days follow up
Major bleeding (BARC 3 to 5), according to the BARC Bleeding Classification (BARC definitions 2011. Circulation. 2011; 123(23): 2736-47. Time-to-event variable, measured in days.
30 days follow up
Major vascular complications
Time Frame: 30 days follow up
Major vascular complications (e.g.: arteriovenous fistula, limb ischemia), as per VARC-2 definitions (VARC 2 definitions 2013, J Thorac Cardiovasc Surg 2013;145:6-23) . Time-to-event variable, measured in days.
30 days follow up
Acute renal dysfunction
Time Frame: 30 days follow up
Acute renal dysfunction (AKIN 1 or above), using the AKIN Classification as described in the VARC-2 definitions (VARC 2 definitions 2013 J Thorac Cardiovasc Surg 2013;145:6-23).
30 days follow up
Increase in Aortic regurgitation
Time Frame: 30 days follow up
Increase in aortic regurgitation by more than one grade (TTE). Binary outcome obtained at the second echocardiogram, performed at discharge.
30 days follow up
Severe hypotension
Time Frame: First 48 hours after the start of PCI.
Severe hypotension (MAP < 60mmHg for more than 10 minutes despite fluid resuscitation or use of vasoactive amines to maintain MAP ≥ 60 mm Hg), or shock, defined based on the definition from the SHOCK trial (1) SBP ≤ 90mmHg for at least 30 minutes, (2) Need for vasopressors to maintain SBP > 90mmHg; (3) evidence of end-organ hypoperfusion; (4) Evidence of elevated filling pressures. A similar concept has been applied in the BCIS-1 study to measure procedural instability (JAMA. 2010;304(8):867-874).
First 48 hours after the start of PCI.
Ventricular arrhythmias
Time Frame: 30 days follow up
VT requiring cardioversion and / or need for CPR. Binary outcome, VF at anytime during follow up. Time-to-event analysis, measured in days.
30 days follow up
Angiographic failure
Time Frame: Assessed at the end of the PCI. This time point (end of PCI) can be variable and is estimated in 40 to 270 minutes after the beginning of the procedure.
Angiographic failure/ procedural failure, as defined in the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention Circulation. 2011;124:e574-e651): post PCI TIMI flow < III, residual stenosis (>50% post-balloon or > 10% post stenting), or presence of thrombus, side branch loss or flow limiting dissection. It is a binary outcome (yes/no answer). No time-to-event analysis will be applied.
Assessed at the end of the PCI. This time point (end of PCI) can be variable and is estimated in 40 to 270 minutes after the beginning of the procedure.
Time of hospitalization
Time Frame: 30 days follow up
Time to hospital discharge (in days).
30 days follow up
Change in Left ventricular ejection fraction
Time Frame: From baseline (beginning of PCI) to the moment of discharge, assessed up to 30 days.
Numerical continuous variable. Change in LVEF measured by trans-thoracic echocardiography at baseline and discharge. Not a time-to-event variable. Unit: %
From baseline (beginning of PCI) to the moment of discharge, assessed up to 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Erasmus Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nicolas v. Mieghem, MD, PhD, Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 28, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pulse version 2.9

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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