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Completed

NCT Number: NCT00814840

Efficiency Study of Triple-Site Cardiac Resynchronization in Patients With Heart Failure

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.

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Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Heart Disease Heart Diseases Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

First Department of Cardiology, Silesian Medical University, Silesian Center for Heart Diseases

Zabrze, 41-800, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cardiac resynchronization pacemaker (InSync Sentry or Concerto, Medtronic, Minneapolis, MN,USA) with two intracardiac leads

Device

Cardiac resynchronization with two intraventricular leads: one in the right ventricle and one in the left ventricle (via the coronary sinus)

Triple-site cardiac resynchronization

Device

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)

Primary outcomes

  1. 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

Secondary outcomes

  1. The occurrence of major adverse cardiovascular events (hospitalization for exacerbated HF requiring modification of pharmacotherapy, heart transplant or death).

    Time frame: five years

Sponsors and collaborators

Lead sponsor

Silesian Centre for Heart Diseases

Other

Registry information

Official study title

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

Acronym: TRUST CRT

Important dates

Study start
2008
Primary completion
2010
Study completion
2015
First posted
Dec 25, 2008
Registry last updated
Apr 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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