Clinical trial NCT00887237: Triple Site Ventricular Stimulation for Cardiac Resynchronization Therapy (CRT) Candidates
Official title: Triple Site Ventricular Stimulation for CRT Candidates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Failure
Keywords: Heart failure
Cardiac resynchronization
Triple site ventricular pacing
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2009-04-23
Enrollment: 76
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: Despite technological progresses the rate of non-responders to cardiac resynchronization therapy (CRT) remains close to 30%. This inconsistent effect of CRT might be due to incomplete resynchronization as dyssynchrony can persist in 25% to 30% of patients during CRT.

One might hypothesize that stimulating the ventricles at a single site is suboptimal and that stimulating multiple left ventricular (LV) or right ventricular (RV) sites may improve ventricular resynchronization and, consequently, its hemodynamic and clinical effects. First studies have suggested that 1 RV + 2 LV pacing sites configurations increased significantly dP/dt, pulse pressure, LV end-diastolic pressure, and is associated with more LV remodeling and better responder rate compared with pacing a single LV site. First studies with 2 RV+LV pacing sites configuration demonstrated increased dP/dt and cardiac output and a decrease of the cardiac dyssynchrony.

The present pilot trial was designed to examine the 6-month safety of biventricular stimulation with 2 right ventricular (RV) and 1 left ventricular (LV) leads - main objective- and to assess its clinical benefit.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* \> 18 years old
* Cardiac resynchronization indication : New York Heart Association (NYHA) Class III/IV \& QRS width \> 120 ms milliseconds (ms) OR NYHA class II \& QRS width \> 150 ms
* Sinus rhythm
* First implant procedure

Exclusion Criteria:

* Permanent ventricular tachycardia
* Permanent pacing indication for 3rd degree atrioventricular (AV) block
* Diagnosed or suspected acute myocarditis
* Less than 1 year life expectancy related to a non-cardiovascular disease
* Impossibility to perform follow-up in the investigative center
* Pregnant woman
* Patient which may not cooperate to study procedures as evaluated by investigator
* Legally protected adult patient or patient unable to give an informed consent
* Patient enrolled in an other clinical trial
* Patient which does not benefit from a social protection system
* Renal insufficiency
* Patient registered on a heart transplant waiting list
* Disease and/or health condition which may interfere with study results

Primary outcomes:
measure: Safety of triple site CRT compared to conventional CRT
timeFrame: 6 months
Secondary outcomes:
measure: Feasibility of triple site CRT
timeFrame: 6 months
measure: Left ventricle remodeling
timeFrame: At 3 and 6 months
measure: LV ejection fraction
timeFrame: At 3 and 6 months
measure: Cardiac dyssynchrony
timeFrame: At 3 and 6 months
measure: Functional status (clinical composite score and NYHA class)
timeFrame: At 3 and 6 months
measure: Exercise capacity (6 minutes hall walk test distance)
timeFrame: At 3 and 6 months
measure: Quality of life
timeFrame: At 3 and 6 months
measure: B-Type Natriuretic Peptide (BNP) level
timeFrame: 6 months
Other outcomes:
Locations:
city: La Rochelle
country: France
facility: Hôpital Saint Louis
state: Ile de France
city: Bordeaux
country: France
facility: University hospital of Bordeaux
city: Lille
country: France
facility: University hospital of Lille
city: Marseille
country: France
facility: University hospital La Timone
city: Montpellier
country: France
facility: University hospital of Montpellier
city: Nancy
country: France
facility: University hospital of Nancy
city: Nantes
country: France
facility: Nouvelles Cliniques Nantaises
city: Nantes
country: France
facility: University hospital of Nantes
city: Paris
country: France
facility: Clinique Bizet
city: Rennes
country: France
facility: University Hospital of Rennes
city: Rouen
country: France
facility: University hospital of Rouen
city: Saint Denis
country: France
facility: Centre Cardiologique du Nord
Study officials:
affiliation: University Hospital, Rouen
name: Frederic Anselme, Pr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anselme F, Bordachar P, Pasquie JL, Klug D, Leclercq C, Milhem A, Alonso C, Deharo JC, Gras D, Probst V, Piot O, Savoure A. Safety, feasibility, and outcome results of cardiac resynchronization with triple-site ventricular stimulation compared to conventional cardiac resynchronization. Heart Rhythm. 2016 Jan;13(1):183-9. doi: 10.1016/j.hrthm.2015.08.036. Epub 2015 Sep 26.