Clinical trial NCT01059175: Dual-Site LV Pacing in CRT Non Responders: Multicenter Randomized Trial
Official title: Dual-Site LV Pacing in CRT Non Responders Multicenter Randomized V3 Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
Cardiac resynchronization therapy
Biventricular stimulation
Multisite stimulation
Non responders
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
name: FRANCE
First posted: 2010-01-29
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score
timeFrame: 12 months
Secondary outcomes:
measure: Distribution of "Improved", "Unchanged" and "Worsened" Patients as Defined Per M. Packer's Clinical Composite Score
timeFrame: 24 months
measure: Rate of Adverse Events
timeFrame: 24 months
measure: Changes in 6 Minutes Hall Walk Distance Observed Between the Enrollment and the End of the Study
timeFrame: 24 months
measure: Number of Patients With at Least One Hospitalization Related to Heart Failure Between Randomization and the End of the Study
timeFrame: 24 months
measure: Time to First Heart Failure Related Hospitalization
timeFrame: 24 months
measure: Overall Mortality
timeFrame: 24 months
measure: Changes in Echocardiographic Indexes of Left Ventricle Remodeling
timeFrame: 24 months
measure: Changes in Quality of Life Score - Minesota Living With Heart Failure Questionnaire
timeFrame: 24 months
Other outcomes:
Locations:
city: Rennes
country: France
facility: University hospital Rennes
Study officials:
affiliation: University Hospital, Bordeaux
name: Bordachar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bordachar P, Alonso C, Anselme F, Boveda S, Defaye P, Garrigue S, Gras D, Klug D, Piot O, Sadoul N, Leclercq C. Addition of a second LV pacing site in CRT nonresponders rationale and design of the multicenter randomized V(3) trial. J Card Fail. 2010 Sep;16(9):709-13. doi: 10.1016/j.cardfail.2010.04.010. Epub 2010 Jun 8.
citation: Bordachar P, Gras D, Clementy N, Defaye P, Mondoly P, Boveda S, Anselme F, Klug D, Piot O, Sadoul N, Babuty D, Leclercq C. Clinical impact of an additional left ventricular lead in cardiac resynchronization therapy nonresponders: The V3 trial. Heart Rhythm. 2018 Jun;15(6):870-876. doi: 10.1016/j.hrthm.2017.12.028. Epub 2017 Dec 26.