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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Radoslaw Lenarczyk, Silesian Centre for Heart Diseases
ClinicalTrials.gov Identifier:
NCT00814840
First received: December 22, 2008
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Congestive Heart Failure
Heart Disease
Device: Cardiac resynchronization pacemaker (InSync Sentry or Concerto, Medtronic, Minneapolis, MN,USA) with two intracardiac leads
Device: Triple-site cardiac resynchronization
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Triple-Site Versus Standard Cardiac Resynchronization Therapy (TRUST CRT) Randomized Trial

Resource links provided by NLM:


Further study details as provided by Silesian Centre for Heart Diseases:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The occurrence of major adverse cardiovascular events (hospitalization for exacerbated HF requiring modification of pharmacotherapy, heart transplant or death). [ Time Frame: five years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2008
Estimated Study Completion Date: January 2015
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00814840

Locations
Poland
First Department of Cardiology, Silesian Medical University, Silesian Center for Heart Diseases
Zabrze, Poland, 41-800
Sponsors and Collaborators
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
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Radoslaw Lenarczyk, Primary Investigator, Silesian Centre for Heart Diseases
ClinicalTrials.gov Identifier: NCT00814840     History of Changes
Other Study ID Numbers: SilesianCHD-KNW-6501-3/08
Study First Received: December 22, 2008
Last Updated: February 5, 2014
Health Authority: Poland: Ministry of Science and Higher Education

Keywords provided by Silesian Centre for Heart Diseases:
Heart failure
Dyssynchrony
Cardiac resynchronization
Triple-site pacing

Additional relevant MeSH terms:
Heart Diseases
Heart Failure
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 28, 2014