Dual-Site LV Pacing in CRT Non Responders Multicenter Randomized V3 Trial
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 84
- Locations
- 1
- Primary Endpoint
- Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score
Time Frame: 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 Outcomes
- 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 in Quality of Life Score - Minesota Living With Heart Failure Questionnaire(24 months)
- Changes in Echocardiographic Indexes of Left Ventricle Remodeling(24 months)
- Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score(24 months)
- Time to First Heart Failure Related Hospitalization(24 months)
- Overall Mortality(24 months)