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

Not Applicable

Completed

Conditions: Heart Failure

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

Registration Number: NCT01059175

Lead Sponsor: Medtronic Bakken Research Center

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 84

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CRT With Dual Site LV Pacing	Additional Endocardial or Epicardial LV Lead	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.
CRT With Dual Site LV Pacing	CRT-P or CRT-D	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.
Standard CRT	CRT-P or CRT-D	Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.

Primary Outcome Measures

Name	Time	Method
Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score	12 months	M. Packer's clinical composite score: patients were classified into 1 of 3 response groups after 12 months follow up : worsened, unchanged, or improved. Worsened : if death, hospitalization because of or associated with worsening HF, demonstrated worsening in NYHA functional class at their 12-month visit, or if investigator judges global clinical state has worsened. Improved :if they had not worsened and had demonstrated improvement in NYHA functional class, or or if investigator judges global clinical state has improved. Unchanged : if none of the previous definition applies.

Secondary Outcome Measures

Name	Time	Method
Rate of Adverse Events	24 months
Number of Patients With at Least One Hospitalization Related to Heart Failure Between Randomization and the End of the Study	24 months
Changes in 6 Minutes Hall Walk Distance Observed Between the Enrollment and the End of the Study	24 months	Changes between baseline and 24months follow up
Changes in Quality of Life Score - Minesota Living With Heart Failure Questionnaire	24 months	Changes between baseline and 24 months follow up Minesota Living with Heart Failure Questionnaire: 21 questions - addition of scores from 1 (better) to 5 (worse) for each questions.
Changes in Echocardiographic Indexes of Left Ventricle Remodeling	24 months	Changes between baseline and 24months follow up
Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score	24 months	Distribution of "improved", "unchanged" and "worsened" patients as defined per M. Packer's clinical composite score at 24 months post implantation of the second left ventricle lead in comparison to the control group M. Packer's clinical composite score: patients were classified into 1 of 3 response groups after 24 months follow up : worsened, unchanged, or improved. Worsened : if death, hospitalization because of or associated with worsening HF, demonstrated worsening in NYHA functional class at their 24-month visit, or if investigator judges global clinical state has worsened. Improved :if they had not worsened and had demonstrated improvement in NYHA functional class, or or if investigator judges global clinical state has improved. Unchanged : if none of the previous definition applies.
Time to First Heart Failure Related Hospitalization	24 months
Overall Mortality	24 months