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

Congestive Heart Failure Clinical Trial

— TRUST CRT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00814840
• Other study ID #: SilesianCHD-KNW-6501-3/08
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 22, 2008
• Last updated: April 12, 2016
• Start date: February 2008
• Est. completion date: January 2015

Study information

• Verified date: April 2016
• Source: Silesian Centre for Heart Diseases
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Science and Higher Education
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2015
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Disease
• Heart Failure

Intervention

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)
• 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)

Locations

Country	Name	City	State
Poland	First Department of Cardiology, Silesian Medical University, Silesian Center for Heart Diseases	Zabrze

Sponsors (1)

Lead Sponsor	Collaborator
Silesian Centre for Heart Diseases

Country where clinical trial is conducted

Poland, 

References & Publications (5)

Leclercq C, Gadler F, Kranig W, Ellery S, Gras D, Lazarus A, Clémenty J, Boulogne E, Daubert JC; TRIP-HF (Triple Resynchronization In Paced Heart Failure Patients) Study Group. A randomized comparison of triple-site versus dual-site ventricular stimulation in patients with congestive heart failure. J Am Coll Cardiol. 2008 Apr 15;51(15):1455-62. doi: 10.1016/j.jacc.2007.11.074. — View Citation

Lenarczyk R, Kowalski O, Kukulski T, Pruszkowska-Skrzep P, Sokal A, Szulik M, Zielinska T, Kowalczyk J, Pluta S, Sredniawa B, Musialik-Lydka A, Kalarus Z. Mid-term outcomes of triple-site vs. conventional cardiac resynchronization therapy: a preliminary study. Int J Cardiol. 2009 Mar 20;133(1):87-94. doi: 10.1016/j.ijcard.2007.12.009. Epub 2008 Feb 19. — View Citation

Lenarczyk R, Kowalski O, Kukulski T, Szulik M, Pruszkowska-Skrzep P, Zielinska T, Kowalczyk J, Pluta S, Duszanska A, Sredniawa B, Musialik-Lydka A, Kalarus Z. Triple-site biventricular pacing in patients undergoing cardiac resynchronization therapy: a feasibility study. Europace. 2007 Sep;9(9):762-7. Epub 2007 Jul 13. — View Citation

Lenarczyk R, Kowalski O, Sredniawa B, Pruszkowska-Skrzep P, Mazurek M, Jedrzejczyk-Patej E, Wozniak A, Pluta S, Glowacki J, Kalarus Z. Implantation feasibility, procedure-related adverse events and lead performance during 1-year follow-up in patients unde — View Citation

Lenarczyk R, Kowalski O, Sredniawa B, Pruszkowska-Skrzep P, Pluta S, Sokal A, Kukulski T, Stabryla-Deska J, Wozniak A, Kowalczyk J, Zielinska T, Mazurek M, Streb W, Zembala M, Kalarus Z. Triple-site versus standard cardiac resynchronization therapy study (TRUST CRT): clinical rationale, design, and implementation. J Cardiovasc Electrophysiol. 2009 Jun;20(6):658-62. doi: 10.1111/j.1540-8167.2008.01394.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The occurrence of major adverse cardiovascular events (hospitalization for exacerbated HF requiring modification of pharmacotherapy, heart transplant or death).		five years	No