Cardiac Resynchronization Therapy (CRT) Based Heart Failure Monitoring Study (zLAP)

October 9, 2020 updated by: Abbott Medical Devices

CRT-D Based Heart Failure Monitoring Study

The purpose of this study is to collect and analyze electrical measurements, timing, and signals from a CRT-D device in heart failure patients who either already have an implanted left atrial pressure sensor or will undergo a simultaneous implantation of a left atrial pressure sensor and a CRT-D device. These devices may be placed at the same time or separately (staged procedure) at the discretion of the investigator. A comparison will be made between the information gathered from the CRT-D system and the information gathered by the left atrial pressure sensor.

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 multi-center feasibility study.

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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.
Observational

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.
8

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

  • New Zealand
      • Christchurch, New Zealand
        • Christchurch Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90033
        • University of Southern California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Sanger Clinic
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • The Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73120
        • Oklahoma Heart Hospital
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Medical Univserity of South Carolina

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 to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with class III heart failure and a CRT-D device implanted.

Description

Inclusion Criteria:

  • Age > 18 and ≤ 85.
  • Have an approved indication per ACC/AHA/HRS guidelines for implantation of a CRT-D. Alternatively, the patient may already have in place an existing Promote CRT-D or other SJM CRT device with similar functions, or have a CRT-D device that requires a generator change. In addition, the patient may be already enrolled in HOMEOSTASIS I or II and completed the 12-month follow-up.
  • Central venous vascular access.
  • Have a legally marketed right atrial bipolar pacing lead, a right ventricular bipolar defibrillation lead, and a left ventricular bipolar pacing lead.
  • Demonstrate capability of Valsalva maneuver with airway pressure > 40 mm Hg for ≥10 seconds.
  • The subject and the treating physician agree that the subject is geographically stable and willing to comply with all required post-procedure follow-up, and that the patient is capable of correct device use as outlined in the protocol.
  • The subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board or Ethics Committee of the respective clinical site

Exclusion Criteria:

  • Intractable HF with resting symptoms despite maximal medical therapy (AHA/ACC Stage D) or active listing for cardiac transplantation (<6 months survival expected).
  • Resting systolic blood pressure < 90 or > 180 mm Hg.
  • Acute Myocardial Infarction (MI), unstable ischemic syndrome within the last 6 weeks.
  • Percutaneous coronary intervention (PCI) or cardiac surgery performed or planned within ± 6 weeks.
  • Coexisting stenotic valve lesions, vegetations, hypertrophic cardiomyopathy, amyloidosis or other infiltrative heart disease, constrictive, restrictive disease, tamponade, or moderate or large pericardial effusion.
  • Subject has a history of deep venous thrombosis or pulmonary embolism within the last 6 months.
  • Surgical correction of congenital heart disease involving atrial septum that will prevent safe implantation of the SJM HeartPOD ISL.
  • Cerebral Vascular Accident (CVA) or Transient Ischemic Attacks (TIA's) within the last 6 months. History of uncorrected cerebral vascular disease.
  • Atrial or ventricular thrombus, tumor or systemic thromboembolism.
  • Atrial septal defect or clinically significant patent foramen ovale.
  • Life expectancy less than one year from malignancy, primary pulmonary hypertension, renal, hepatic, or neurological condition, etc.
  • Gastrointestinal bleeding during the last 6 months.
  • Coagulopathy or uninterruptible anticoagulation therapy or unable to take antiplatelet medications.
  • Creatinine > 2.4 gm/dl (212 µmol/L) at enrollment.
  • Active systemic infection.
  • The subject is currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints.
  • Have a contraindication for an emergency thoracotomy
  • Have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin.
  • Positive pregnancy test at enrollment or planning a pregnancy in the next 12 months.
  • Patient is pacemaker dependent, where cessation of pacemaker function consistently results in syncope or ventricular asystole.
  • Incompatible previously implanted intracardiac devices.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
HeartPOD™ System with Cardiac Resynchronization Therapy
All patients will receive both a HeartPod device and a CRT-D device.
Device: Cardiac Resynchronization Therapy
Pacing of the left ventricle to resynchronize ventricular contraction.
Other Names:
  • CRT-D
Device: HeartPOD™ System
Left atrial pressure monitoring.

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
Time Frame
Determine which heart failure monitoring feature acquired by the CRT device correlates most closely with simultaneously measured left ventricular filling pressure, as measured by left atrial pressure.
Time Frame: 12 months
12 months

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.
Abbott Medical Devices

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: Richard Troughton, MD, Christchurch Hospital - Christchurch, New Zealand

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

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.
January 1, 2008

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.
September 1, 2011

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 1, 2015

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).
February 29, 2008

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.
March 7, 2008

First Posted (Estimate)

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.
March 10, 2008

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.
October 12, 2020

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.
October 9, 2020

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.
October 1, 2020

More Information

Terms related to this study

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.
  • 60015786

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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