Status:
COMPLETED
Clinical Evaluation on Advanced Resynchronization
Lead Sponsor:
LivaNova
Conditions:
Heart Failure
Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aim of the study is to compare clinical benefits of the cardiac resynchronisation (CRT) achieved by the PEA optimised pacing configuration and a CRT optimised by standard clinical procedure. PEA ...
Detailed Description
The study is a prospective, multicentre, controlled and randomised clinical investigation, with two single-blinded arms. The objective of the study is to compare the clinical benefits of Cardiac Resy...
Eligibility Criteria
Inclusion
- The patient candidate for inclusion in the study must be indicated for implantation of a Biventricular pacing system, with the following clinical conditions:
- Severe Heart Failure (NYHA Class III or IV)
- Cardiomyopathy of any etiology
- Sinus rhythm
- Reduced Left-Ventricular Ejection Fraction
- Left-Ventricular End Diastolic Diameter greater than or equal to 30 mm/m2 (LVEDD\>30 mm/m2)
- QRS Duration:
- \> 150 ms or
- \> 120 ms and documented Mechanical Dissynchrony (by ECHO) meeting two out of three of the following criteria:
- Aortic Pre-Ejection Delay \> 140 ms
- Interventricular Mechanical Delay \> 40 ms
- Delayed activation of postero-lateral Left Ventricular wall (after mitral valve opening)
- Optimal and stable (1 month before inclusion) pharmacological treatment, including, if tolerated, Beta Blockers, Angiotensin-Converting Enzyme (ACE) Inhibitors or ACE Inhibitor substitutes, Spironolactone, and diuretics
Exclusion
- Any patient who has one of the following characteristics will be excluded from the study:
- ICD indication (Life-threatening ventricular arrhythmias)
- Persistent or permanent Atrial Arrhythmia without possibility to restore sinus rhythm (spontaneous termination, anti-tachycardia pacing, pharmacological or electrical cardioversion).
- Patient already implanted with a conventional pacemaker device
- Myocardial infarction within the last three months
- Heart surgery, or revascularization within the last three months, or expected
- Heart surgery refused because of co-morbidity factors
- Included in transplantation list
- Already enrolled in other study
- Life expectancy less than 1 year
- Pregnancy
- Age less than 18
- Forfeiture of freedom or under guardianship
- Not able to understand the aim of the study and its procedures
- Refusing to cooperate
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2008
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT00658203
Start Date
November 1 2005
End Date
February 1 2008
Last Update
April 14 2008
Active Locations (36)
Enter a location and click search to find clinical trials sorted by distance.
1
CH Albi
Albi, France
2
CHU Angers
Angers, France
3
CHU Bordeaux
Bordeaux, France
4
CH Lomme
Lomme, France