Status:
COMPLETED
Triple Site Ventricular Stimulation for Cardiac Resynchronization Therapy (CRT) Candidates
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 resynchronizatio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00887237
Start Date
May 1 2009
End Date
July 1 2012
Last Update
July 8 2013
Active Locations (12)
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1
University hospital of Bordeaux
Bordeaux, France, 33000
2
University hospital of Lille
Lille, France, 59000
3
University hospital La Timone
Marseille, France, 13000
4
University hospital of Montpellier
Montpellier, France, 34000