Efficiency Study of Triple-Site Cardiac Resynchronization in Patients With Heart Failure (TRUST CRT)

April 12, 2016 updated by: Radoslaw Lenarczyk, Silesian Centre for Heart Diseases

Triple-Site Versus Standard Cardiac Resynchronization Therapy (TRUST CRT) Randomized Trial

The purpose of this study is to assess the efficiency of permanent biventricular pacing using three ventricular leads in terms of reduction in adverse cardiac events rates, improvement in cardiac capacity and patients' functional status in subjects with congestive heart failure and a physiologic (sinus) rhythm.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2
  • Phase 3

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

  • Poland
      • Zabrze, Poland, 41-800
        • First Department of Cardiology, Silesian Medical University, Silesian Center for Heart Diseases

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18 or more,
  • Congestive heart failure (HF) in NYHA class III-IV within last 90 days despite optimal medical treatment,
  • Left ventricular ejection fraction (EF) <=35% measured with echocardiography,
  • Sinus rhythm >90% of the time in 24-h Holter monitoring 1-3 days prior to randomization,
  • Inter- or intraventricular mechanical dyssynchrony ≥40ms measured with pulse Doppler and tissue Doppler echocardiography,
  • Optimal pharmacotherapy during the last 90 days,
  • Signed informed, written consent.

Exclusion Criteria:

  • Pregnancy or breastfeeding,
  • Unstable HF requiring hospitalization with intravenous inotropic drugs within last 90 days,
  • Myocardial infarction, percutaneous/surgical revascularization or any cardiosurgical procedure within 90 days prior to randomization,
  • Stroke within last 90 days,
  • History of chronic or persistent atrial fibrillation, flutter, tachycardia,
  • Acute myocarditis,
  • Implanted previously pacemaker, ICD or CRT-device,
  • Participation in a concurrent trial that could confuse the results of this study,
  • Mechanical right heart valve,
  • Prior heart transplant,
  • Valvular disease that is indication for valve surgery,
  • Coronary heart disease if percutaneous or surgical revascularization is indicated and possible,
  • Any state, apart from HF, that limits the estimated survival time to <1 year,
  • Unwillingness or inability to understand the nature of the study, to participate or to give written informed consent.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Triple-site group
Triple-site resynchronization group
Device: Triple-site cardiac resynchronization
Cardiac resynchronization pacemaker (InSync Sentry or Concerto, Medtronic, Minneapolis, MN,USA) with three intraventricular leads: one in the right ventricle and two in the left ventricle (via the coronary sinus). Two left ventricular leads connected with Y-connector (Lead Adaptor 2827, Medtronic, Minneapolis, MN, USA)
Active Comparator: Standard resynchronization group
Standard (double-site) resynchronization group
Device: Cardiac resynchronization pacemaker (InSync Sentry or Concerto, Medtronic, Minneapolis, MN,USA) with two intracardiac leads
Cardiac resynchronization with two intraventricular leads: one in the right ventricle and one in the left ventricle (via the coronary sinus)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Combined end-point of alive status, freedom from hospitalization for HF or heart transplantation, relative ≥10% increase in LV ejection fraction, ≥10% in VO2max and ≥10% in 6MWD.
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
The occurrence of major adverse cardiovascular events (hospitalization for exacerbated HF requiring modification of pharmacotherapy, heart transplant or death).
Time Frame: five years
five years

Collaborators and Investigators

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

Sponsor

Silesian Centre for Heart Diseases

Investigators

  • Principal Investigator: Radosław Lenarczyk, M.D., First Department of Cardiology, Silesian Medical University, Silesian Center for Heart Diseases
  • Study Chair: Zbigniew Kalarus, M.D., First Department of Cardiology, Silesian Medical University, Silesian Center for Heart Diseases

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

February 1, 2008

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

December 22, 2008

First Submitted That Met QC Criteria

December 23, 2008

First Posted (Estimate)

December 25, 2008

Study Record Updates

Last Update Posted (Estimate)

April 13, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SilesianCHD-KNW-6501-3/08

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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