Triple Site Ventricular Stimulation for Cardiac Resynchronization Therapy (CRT) Candidates
TRIV
1 other identifier
interventional
76
1 country
12
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 heart-failure
Started May 2009
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2009
CompletedFirst Posted
Study publicly available on registry
April 23, 2009
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJuly 8, 2013
July 1, 2013
3.2 years
April 22, 2009
July 3, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of triple site CRT compared to conventional CRT
6 months
Secondary Outcomes (8)
Feasibility of triple site CRT
6 months
Left ventricle remodeling
At 3 and 6 months
LV ejection fraction
At 3 and 6 months
Cardiac dyssynchrony
At 3 and 6 months
Functional status (clinical composite score and NYHA class)
At 3 and 6 months
- +3 more secondary outcomes
Study Arms (2)
TRIV
EXPERIMENTALCardiac resynchronization with triple site ventricular stimulation (2 RV leads and 1 LV lead)
BIV
ACTIVE COMPARATORConventional cardiac resynchronization
Interventions
CRT with triple site ventricular stimulation (2 RV leads and 1 LV lead)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
University hospital of Bordeaux
Bordeaux, 33000, France
University hospital of Lille
Lille, 59000, France
University hospital La Timone
Marseille, 13000, France
University hospital of Montpellier
Montpellier, 34000, France
University hospital of Nancy
Nancy, 54000, France
Nouvelles Cliniques Nantaises
Nantes, 44000, France
University hospital of Nantes
Nantes, 44000, France
Clinique Bizet
Paris, 75016, France
University Hospital of Rennes
Rennes, 35000, France
University hospital of Rouen
Rouen, 76031, France
Centre Cardiologique du Nord
Saint-Denis, 93200, France
Hôpital Saint Louis
La Rochelle, Île-de-France Region, 17000, France
Related Publications (1)
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.
PMID: 26325531DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frederic Anselme, Pr
University Hospital, Rouen
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2009
First Posted
April 23, 2009
Study Start
May 1, 2009
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
July 8, 2013
Record last verified: 2013-07