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

Medtronic

Status: Completed

Conditions: Heart Failure

Treatments: Device: Additional Endocardial or Epicardial LV Lead; Device: CRT-P or CRT-D

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01059175

Medtronic

Details and patient eligibility

About

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.

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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84 participants in 2 patient groups

CRT With Dual Site LV Pacing

Experimental group

Description:

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.

Treatment:

Device: CRT-P or CRT-D

Device: Additional Endocardial or Epicardial LV Lead

Standard CRT

Active Comparator group

Description:

Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.

Treatment:

Device: CRT-P or CRT-D