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

NCT00814840 | Completed Phase 2 DMC

• 1 other identifier: SilesianCHD-KNW-6501-3/08
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Congestive Heart Failure; Heart Disease

Keywords

Heart failure; Dyssynchrony; Cardiac resynchronization; Triple-site pacing

Outcome Measures

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.

  six months

Secondary Outcomes (1)

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

  five years

Study Arms (2)

Triple-site group

ACTIVE COMPARATOR

Triple-site resynchronization group

Device: Triple-site cardiac resynchronization

Standard resynchronization group

ACTIVE COMPARATOR

Standard (double-site) resynchronization group

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

Interventions

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)

Standard resynchronization group

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)

Triple-site group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Silesian Centre for Heart Diseases: lead

Study Sites (1)

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

Zabrze, 41-800, Poland

Location

Related Publications (8)

• 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.

  PMID: 18242737 BACKGROUND

• 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. doi: 10.1093/europace/eum140. Epub 2007 Jul 13.

  PMID: 17631515 BACKGROUND

• Leclercq C, Gadler F, Kranig W, Ellery S, Gras D, Lazarus A, Clementy 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.

  PMID: 18402900 BACKGROUND

• 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.

  PMID: 19635069 BACKGROUND

• 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 undergoing triple-site cardiac resynchronization therapy: a substudy of TRUST CRT randomized trial. J Cardiovasc Electrophysiol. 2012 Nov;23(11):1228-36. doi: 10.1111/j.1540-8167.2012.02375.x. Epub 2012 May 31.

  PMID: 22651239 RESULT

• Lenarczyk R, Jedrzejczyk-Patej E, Mazurek M, Szulik M, Kowalski O, Pruszkowska P, Sokal A, Sredniawa B, Boidol J, Kowalczyk J, Podolecki T, Mencel G, Kalarus Z. Quality of life in cardiac resynchronization recipients: association with response and impact on outcome. Pacing Clin Electrophysiol. 2015 Jan;38(1):8-17. doi: 10.1111/pace.12523. Epub 2014 Oct 15.

  PMID: 25319879 DERIVED

• Kowalczyk J, Lenarczyk R, Kowalski O, Podolecki T, Francuz P, Pruszkowska-Skrzep P, Szulik M, Mazurek M, Jedrzejczyk-Patej E, Sredniawa B, Kalarus Z; Triple-Site Versus Standard Cardiac Resynchronization Trial (TRUST CRT) Investigators. Contrast-induced acute kidney injury in patients undergoing cardiac resynchronization therapy-incidence and prognostic importance. Sub-analysis of data from randomized TRUST CRT trial. J Interv Card Electrophysiol. 2014 Jun;40(1):1-8. doi: 10.1007/s10840-014-9887-x. Epub 2014 Mar 14.

  PMID: 24626998 DERIVED

• Boidol J, Sredniawa B, Kowalski O, Szulik M, Mazurek M, Sokal A, Pruszkowska-Skrzep P, Kukulski T, Kalarus Z, Lenarczyk R; Triple-Site Versus Standard Cardiac Resynchronisation Trial (TRUST CRT) Investigators. Many response criteria are poor predictors of outcomes after cardiac resynchronization therapy: validation using data from the randomized trial. Europace. 2013 Jun;15(6):835-44. doi: 10.1093/europace/eus390. Epub 2013 Mar 13.

  PMID: 23487543 DERIVED

MeSH Terms

Conditions

Heart Failure; Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Radosław Lenarczyk, M.D.

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

  PRINCIPAL INVESTIGATOR

• Zbigniew Kalarus, M.D.

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: December 22, 2008
• First Posted: December 25, 2008
• Study Start: February 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: January 1, 2015
• Last Updated: April 13, 2016

Record last verified: 2016-04

Locations

PL (1)