Status:
COMPLETED
APAF: Assessment of Cardiac Resynchronization Therapy in Patients With Permanent Atrial Fibrillation
Lead Sponsor:
Azienda USL Reggio Emilia - IRCCS
Collaborating Sponsors:
Medtronic
Conditions:
Congestive Heart Failure
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
A suboptimal level of resynchronization (cardiac resynchronization therapy \[CRT\]) achieved in many patients with actual standards and techniques based on tissue-Doppler echocardiography could be mor...
Detailed Description
Background: Cardiac resynchronization therapy (CRT) in patients in atrial fibrillation (AF) seems to provide modest favorable effect compared with RV pacing. In the Optimal Pacing SITE (OPSITE) trial ...
Eligibility Criteria
Inclusion
- Patients with permanent AF in whom a clinical decision had been made to undertake complete AV junction ablation and ventricular pacing because of drug-refractory, severely symptomatic, uncontrolled high ventricular rate
- Patients with permanent AF, drug-refractory heart failure, depressed LV function in whom a clinical decision had been made to undertake left ventricular synchronization pacing
Exclusion
- New York Heart Association class IV heart failure, or systolic blood pressure ≥80 mmHg
- Severe concomitant non cardiac disease
- Need for surgical intervention
- Myocardial infarction within 3 months
- Primary hypertrophic cardiomyopathy
- Arrhythmogenic right ventricular dysplasia
- Primary valvular heart disease
- Sustained ventricular tachycardia or ventricular fibrillation
- Previously implanted pacemaker
- Inability to obtain reliable RV and LV pacing and persistent AV block
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2010
Estimated Enrollment :
458 Patients enrolled
Trial Details
Trial ID
NCT00111527
Start Date
May 1 2005
End Date
March 1 2010
Last Update
June 12 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Michele Brignole
Lavagna, Genova, Italy, 16033
2
Arcispedale S Maria Nuova
Reggio Emilia, Reggio Emilia, Italy, 42100