Overview

This trial is active, not recruiting.

Condition heart failure
Treatments additional endocardial or epicardial lv lead, crt-p or crt-d
Phase phase 3
Sponsor Medtronic Bakken Research Center
Collaborator Medtronic
Start date September 2010
End date September 2014
Trial size 84 participants
Trial identifier NCT01059175, Medtronic

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.
additional endocardial or epicardial lv lead
Addition of a second left ventricular endocardial or epicardial lead
crt-p or crt-d
Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device
(Active Comparator)
Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.
crt-p or crt-d
Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device

Primary Outcomes

Measure
Distribution of "improved", "unchanged" and "worsened" patients as defined per M. Packer's clinical composite score
time frame: 12 months

Secondary Outcomes

Measure
Distribution of "improved", "unchanged" and "worsened" patients as defined per M. Packer's clinical composite score
time frame: 24 months
Rate of adverse events
time frame: 24 months
Changes in functional capacity, exercise tolerance and quality of life observed between the enrollment and the end of the study
time frame: 24 months
Number of hospitalizations related to heart failure between randomization and the end of the study
time frame: 24 months
Time to first heart failure related hospitalization
time frame: 24 months
Overall mortality
time frame: 24 months
Echocardiographic indexes of LV remodeling
time frame: 24 months
Changes in blood concentrations of N-terminal pro-B type natriuretic peptide (NT pro-BNP)
time frame: 24 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Dual-Site LV Pacing in CRT Non Responders Multicenter Randomized V3 Trial
Principal investigator Pierre Bordachar, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Medtronic Bakken Research Center.