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

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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