Loading clinical trials...

Dual-Site LV Pacing in CRT Non Responders: Multicenter Randomized Trial | Clinical Trials | Clareo Health

COMPLETEDNA

Dual-Site LV Pacing in CRT Non Responders: Multicenter Randomized Trial

Dual-Site LV Pacing in CRT Non Responders Multicenter Randomized V3 Trial

NCT01059175•Medtronic Cardiac Rhythm and Heart Failure

Summary

Cardiac resynchronization therapy (CRT) is an effective treatment of heart failure (HF) refractory to optimal medical management, in presence of a depressed left ventricular (LV) ejection fraction and a wide QRS complex. It is mainly limited by a high proportion of non-responders. Attempts have been made, in small studies, to increase the number of stimulation sites in order to optimize the resynchronization therapy. V3 is a planned multicenter, randomized trial whose objective is to evaluate the clinical benefit conferred by the addition of a second endocardial or epicardial LV lead in non-responders after at least 6 months of standard biventricular stimulation. The V3 trial will examine the clinical benefit conferred by the addition of a second LV lead in non-responders compared to standard CRT.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Age greater than 18 years
•Recipient of a CRT-P or CRT-D system for greater than 6 for standard indications, including LV ejection fraction greater than 35 percent and New York Heart Association (NYHA) functional class III or IV
•Optimized biventricular stimulation and medical therapy since implantation of the system
•Presence of sinus rhythm, or atrial fibrillation with spontaneous or induced complete atrio-ventricular block
•Greater than 93 percent LV stimulation since the last device interrogation, with a LV capture threshold less than 5.0 Volts/0.5 milliseconds
•Unchanged or worsened clinical status by CRT, according to the HF composite endpoint described by M. Packer, in absence of a reversible cause
•Signature of a written, informed consent to participate in the trial

Exclusion Criteria

•LV lead location in the great cardiac vein
•Life-expectancy less than 1 year due to concomitant, non-cardiovascular disorders
•Chronic renal dialysis
•Concomitant disorder which might interfere with the results of the V3 trial
•Blood systolic pressure greater than 180 millimeters of mercury (mmHg) or diastolic pressure greater than 95 mmHg despite optimal medical management
•History of stroke, myocardial infarction or unstable angina pectoris within the last 3 months
•Presence of correctible valvular disease
•Subject unable to attend follow-up at the investigative center or unable, for physical or mental reasons, to comply with the trial's procedures, or to sign the informed consent
•Subject is pregnant
•Subject participates in another research project

Locations (1)

University hospital Rennes

Rennes, France

Key Dates

Start Date

September 1, 2010

Primary Completion Date

September 1, 2014

Completion Date

September 1, 2014

Last Updated

July 2, 2025

Enrollment

ACTUAL participants

Conditions

Heart Failure

Interventions

Additional Endocardial or Epicardial LV Lead

DEVICE

CRT-P or CRT-D

DEVICE

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

NCT07484009

Acute Heart Failure (AHF)Heart Failure (for Example, Fluid Overload)+1 more

View study

RECRUITING

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

NCT07191730

CardiotoxicityHeart Failure+2 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 2, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Dual-Site LV Pacing in CRT Non Responders: Multicenter Randomized Trial

Inclusion Criteria

Exclusion Criteria

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

Proof-of-concept of a Behavioral Intervention to Improve the Cardiovascular Health of People Living With HIV

Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease

Assessment of Physical Activity and Cardiovascular Outcomes in Patients With Chronic Heart Failure