Triple Site Ventricular Stimulation for Cardiac Resynchronization Therapy (CRT) Candidates (TRIV)
Triple Site Ventricular Stimulation for CRT Candidates
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Bordeaux, France, 33000
- University hospital of Bordeaux
-
Lille, France, 59000
- University Hospital of Lille
-
Marseille, France, 13000
- University hospital La Timone
-
Montpellier, France, 34000
- University hospital of Montpellier
-
Nancy, France, 54000
- University Hospital of Nancy
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Nantes, France, 44000
- University Hospital of Nantes
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Nantes, France, 44000
- Nouvelles Cliniques Nantaises
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Paris, France, 75016
- Clinique BIZET
-
Rennes, France, 35000
- University Hospital of Rennes
-
Rouen, France, 76031
- University hospital of Rouen
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Saint Denis, France, 93200
- Centre Cardiologique du Nord
-
-
Ile de France
-
La Rochelle, Ile de France, France, 17000
- Hôpital Saint Louis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: TRIV
Cardiac resynchronization with triple site ventricular stimulation (2 RV leads and 1 LV lead)
|
CRT with triple site ventricular stimulation (2 RV leads and 1 LV lead)
|
|
Active Comparator: BIV
Conventional cardiac resynchronization
|
Conventional cardiac resynchronization
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Safety of triple site CRT compared to conventional CRT
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Feasibility of triple site CRT
Time Frame: 6 months
|
6 months
|
|
Left ventricle remodeling
Time Frame: At 3 and 6 months
|
At 3 and 6 months
|
|
LV ejection fraction
Time Frame: At 3 and 6 months
|
At 3 and 6 months
|
|
Cardiac dyssynchrony
Time Frame: At 3 and 6 months
|
At 3 and 6 months
|
|
Functional status (clinical composite score and NYHA class)
Time Frame: At 3 and 6 months
|
At 3 and 6 months
|
|
Exercise capacity (6 minutes hall walk test distance)
Time Frame: At 3 and 6 months
|
At 3 and 6 months
|
|
Quality of life
Time Frame: At 3 and 6 months
|
At 3 and 6 months
|
|
B-Type Natriuretic Peptide (BNP) level
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Frédéric ANSELME, Pr, University Hospital, Rouen
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRIV
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