Status:
WITHDRAWN
Multi Point Pacing vs. Conventional STUDY PROTOCOL
Lead Sponsor:
CMC Ambroise Paré
Conditions:
Compare Two Programming Modalities for CRT Devices in Heart Failure Patients With an Indication for Cardiac Resynchronization Therapy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The Purpose of this study is to compare two programming modalities for CRT devices in Heart Failure patients with an indication for Cardiac Resynchronization Therapy
Eligibility Criteria
Inclusion
- Patients with indication for CRT (-P or -D) as per ESC guidelines. Ability to provide written informed consent. Optimal Medical Therapy for at least 3 months
Exclusion
- \< 18 years and younger
- Pregnant or breastfeeding patients
- Non-LBBB patients (RBBB, intra-ventricular delay)
- Non-ambulatory NYHA class IV effort tolerance
- Myocardial infarction within 40 days before enrolment
- Cardiac surgery or revascularization procedure within 3 months before enrolment, or scheduled in the following 6 months
- Atrial Fibrillation (AF) patients unless AV node ablation is performed, or complete AV block is present (to ensure optimal CRT delivery)
- Patients with life expectancy of less than 12 months due to other medical conditions
- Patients who are involved in another investigational study (device or medical)
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04334018
Start Date
March 1 2018
End Date
March 1 2023
Last Update
April 3 2020
Active Locations (6)
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1
PHc hôpital d'Antibes la Fontonne
Antibes, France, 06606
2
Centre hospitalier de Cannes
Cannes, France, 06150
3
CMC Ambroise Paré
Neuilly-sur-Seine, France, 92200
4
CHU Nice
Nice, France, 06100