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

NCT00887237 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2013-07-08

No results posted yet for this study

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

Interventions

DEVICE

CRT with triple site ventricular stimulation

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

DEVICE

Conventional cardiac resynchronization

Conventional cardiac resynchronization

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • Frederic Anselme, Pr · University Hospital, Rouen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00887237 on ClinicalTrials.gov