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

Sponsor

Silesian Centre for Heart Diseases (Other)

Overall Status

Completed

CT.gov ID

NCT00814840

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Jul 1, 2010

Actual Study Completion Date :

Jan 1, 2015

Arms and Interventions

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)

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)

Outcome Measures

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. [six months]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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