Comparison of Multi-point Pacing and Conventional CRT Through Non-invasive Hemodynamics Measurement and Global Longitudinal Strain Assessment (COMPACT-MPP)

March 6, 2020 updated by: Antonio Curcio, Azienda Ospedaliera Universitaria Mater Domini, Catanzaro
Pilot, perspective, multi-center non-randomized study comparing Multi-point pacing and conventional CRT through non-invasive hemodynamics measurement and Global Longitudinal Strain assessment

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.

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.
52

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

  • Italy
      • Napoli, Italy, 80100
        • AO Cardarelli
      • Napoli, Italy, 80100
        • AOU Federico II
    • CZ
      • Catanzaro, CZ, Italy, 88100
        • Azienda Ospedaliera Policlinico Mater Domini

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

Sampling Method

Non-Probability Sample

Study Population

- Patients with standard indications to CRT satisfying the study Inclusion and Exclusion Criteria

Description

Inclusion Criteria:

  • Recent or scheduled implantation of CRT-D system with quadripolar lead and MPP technology in patient with indications to CRT according to current guidelines

Exclusion Criteria:

  • Patients in Atrial Tachycardia (AT) or Atrial Fibrillation (AF) at the time of the enrollment or with persistent or long-standing persistent/chronic AF
  • NYHA IV patients
  • Right Bundle Branch Block

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.
standard BIV
the following group describes the effects of the left ventricular stimulation involving a dipole of two electrodes located inside a suitable vessel branch of the coronary sinus (CS). Standard BIV pacing modality can be achieved by either a quadripolar electrode implanted in the CS, of which only two poles will be used for cardiac resynchronization therapy, or by a bipolar electrode equipped with just two electrodes. The latter describes the old technology, requiring a change into typology of generator which has to display an IS-1 connection (due to different distal terminal of the electrode itself), instead of the new one IS-4 connection that has been developed for quadripolar electrodes.
MPP BIV
Such modality of left ventricular stimulation requires a dynamic use of the four electrodes located in the proximal segment of the electrocatheter that allows the recruitment of a vast area of the left ventricle. It is limited by the presence of scars on left ventricle surface, or phrenic nerve inadvertent stimulation.
Device: Cardiac Resynchronization Therapy device programming
Implanted CRT-D devices settings will be programmed based on the best acute hemodynamic response assessed non-invasively

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
Acute improvement in cardiac function (1)
Time Frame: 24-48 hours after CRT-D implantation
change in dP/dtmax, expressed in mmHg/s, assessed through photoplethysmography. This assessment represents in a non-invasive fashion, the rise in pressure (P) developed inside left ventricle during contraction over time.
24-48 hours after CRT-D implantation
Acute improvement in cardiac function (2)
Time Frame: 24-48 hours after CRT-D implantation
change in global longitudinal strain, assessed through echocardiography. This assessment elucidates longitudinal shortening of the left ventricle as a percentage (change in length as a proportion to baseline length). GLS is derived from speckle tracking, and analyzed by post-processing of apical images of the left ventricle.
24-48 hours after CRT-D implantation

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
Delayed response (1)
Time Frame: 3 Months
change in GLS. Participants will investigate whether left ventricular remodeling upon "patient-tailored" biventricular stimulation will behave differentially according to type of stimulation; the total amount of CRT-responder patients will be therefore considered
3 Months
Delayed response (2)
Time Frame: 3 Months
change in NYHA class. Participants will check if functional status will change after optimized biventricular stimulation therapy and will provide clinical data on CRT responders.
3 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.
Azienda Ospedaliera Universitaria Mater Domini, Catanzaro

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.
November 21, 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.
October 30, 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.
February 27, 2020

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).
July 12, 2018

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 5, 2020

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.
March 6, 2020

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 10, 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.
March 6, 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.
March 1, 2020

More Information

Terms related to this study

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.
  • 178

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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