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

Study Overview
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Brief Summary
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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.

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

Conditions
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Congestive Heart Failure, Heart Disease

Intervention / Treatment
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* Device: Cardiac resynchronization pacemaker (InSync Sentry or Concerto, Medtronic, Minneapolis, MN,USA) with two intracardiac leads
* Device: Triple-site cardiac resynchronization


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Triple-site group<br>Triple-site resynchronization group | Device: Triple-site cardiac resynchronization<br>* 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)<br>|
| Active Comparator: Standard resynchronization group<br>Standard (double-site) resynchronization group | Device: Cardiac resynchronization pacemaker (InSync Sentry or Concerto, Medtronic, Minneapolis, MN,USA) with two intracardiac leads<br>* Cardiac resynchronization with two intraventricular leads: one in the right ventricle and one in the left ventricle (via the coronary sinus)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | six months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart failure, Dyssynchrony, Cardiac resynchronization, Triple-site pacing