Triple Site Ventricular Stimulation for Cardiac Resynchronization Therapy (CRT) Candidates

NCT ID: NCT00887237

Last Updated: 2013-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2012-07-31

Brief Summary

Despite technological progresses the rate of non-responders to cardiac resynchronization therapy (CRT) remains close to 30%. This inconsistent effect of CRT might be due to incomplete resynchronization as dyssynchrony can persist in 25% to 30% of patients during CRT.

One might hypothesize that stimulating the ventricles at a single site is suboptimal and that stimulating multiple left ventricular (LV) or right ventricular (RV) sites may improve ventricular resynchronization and, consequently, its hemodynamic and clinical effects. First studies have suggested that 1 RV + 2 LV pacing sites configurations increased significantly dP/dt, pulse pressure, LV end-diastolic pressure, and is associated with more LV remodeling and better responder rate compared with pacing a single LV site. First studies with 2 RV+LV pacing sites configuration demonstrated increased dP/dt and cardiac output and a decrease of the cardiac dyssynchrony.

The present pilot trial was designed to examine the 6-month safety of biventricular stimulation with 2 right ventricular (RV) and 1 left ventricular (LV) leads - main objective- and to assess its clinical benefit.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TRIV

Cardiac resynchronization with triple site ventricular stimulation (2 RV leads and 1 LV lead)

Group Type: EXPERIMENTAL

CRT with triple site ventricular stimulation

Intervention Type: DEVICE

CRT with triple site ventricular stimulation (2 RV leads and 1 LV lead)

BIV

Conventional cardiac resynchronization

Group Type: ACTIVE_COMPARATOR

Conventional cardiac resynchronization

Intervention Type: DEVICE

Conventional cardiac resynchronization

Interventions

CRT with triple site ventricular stimulation

CRT with triple site ventricular stimulation (2 RV leads and 1 LV lead)

Intervention Type: DEVICE

Conventional cardiac resynchronization

Conventional cardiac resynchronization

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Signed informed consent
• > 18 years old
• Cardiac resynchronization indication : New York Heart Association (NYHA) Class III/IV & QRS width > 120 ms milliseconds (ms) OR NYHA class II & QRS width > 150 ms
• Sinus rhythm
• First implant procedure

Exclusion Criteria

• Permanent ventricular tachycardia
• Permanent pacing indication for 3rd degree atrioventricular (AV) block
• Diagnosed or suspected acute myocarditis
• Less than 1 year life expectancy related to a non-cardiovascular disease
• Impossibility to perform follow-up in the investigative center
• Pregnant woman
• Patient which may not cooperate to study procedures as evaluated by investigator
• Legally protected adult patient or patient unable to give an informed consent
• Patient enrolled in an other clinical trial
• Patient which does not benefit from a social protection system
• Renal insufficiency
• Patient registered on a heart transplant waiting list
• Disease and/or health condition which may interfere with study results

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederic Anselme, Pr

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Rouen

Locations

University hospital of Bordeaux

Bordeaux, , France

University hospital of Lille

Lille, , France

University hospital La Timone

Marseille, , France

University hospital of Montpellier

Montpellier, , France

University hospital of Nancy

Nancy, , France

Nouvelles Cliniques Nantaises

Nantes, , France

University hospital of Nantes

Nantes, , France

Clinique Bizet

Paris, , France

University Hospital of Rennes

Rennes, , France

University hospital of Rouen

Rouen, , France

Centre Cardiologique du Nord

Saint-Denis, , France

Hôpital Saint Louis

La Rochelle, Île-de-France Region, France

Countries

France

References

Anselme F, Bordachar P, Pasquie JL, Klug D, Leclercq C, Milhem A, Alonso C, Deharo JC, Gras D, Probst V, Piot O, Savoure A. Safety, feasibility, and outcome results of cardiac resynchronization with triple-site ventricular stimulation compared to conventional cardiac resynchronization. Heart Rhythm. 2016 Jan;13(1):183-9. doi: 10.1016/j.hrthm.2015.08.036. Epub 2015 Sep 26.

Reference Type: DERIVED

PMID: 26325531 (View on PubMed)

Other Identifiers

TRIV

Identifier Type: -

Identifier Source: org_study_id