Heart Rate Regularization in Patients With Permanent Atrial Fibrillation Post Marketing Study (RARE-PEARL)
Permanent Atrial Fibrillation
About this trial
This is an interventional treatment trial for Permanent Atrial Fibrillation focused on measuring Permanent atrial fibrillation, VVI(R) pacing, rate regularization
Eligibility Criteria
Inclusion Criteria: Patient has signed informed consent form Patient with permanent atrial fibrillation, standard indication for VVI(R) pacing, and at least 1 episode of rate irregularity in the last month New York Heart Association (NYHA) Class I, II, III Patient is able to comply with follow-up times and will comply with the protocol > 18 years of age Exclusion Criteria: Paroxysmal atrial fibrillation NYHA Class IV Left ventricular ejection fraction (LVEF) < 35 Patients with unstable angina Patients who have experienced an acute myocardial infarction or received coronary artery revascularization (CABG), or coronary angioplasty (PTCA) within 3 months prior to enrolment Patient candidate for cardiac surgery, or coronary angioplasty (PTCA) Patients who experienced a cardiovascular accident (CVA) or transient ischemic attack (TIA) with permanent disability Life expectancy < 12 months due to other medical conditions Pregnancy The patient is enrolled in any concurrent (drug and/or device) study
Sites / Locations
- Divisione di Cardiologia - Ospedale Civile
- Divisione di Cardiologia - ospedale Civile
- Divisione di Cardiologia - Ospedale Civile
- Divisione di Cardiologia - Az. Ospedaliera Umberto I
- Divisione di Cardiologia - USL 8
- Divisione di Cardiologia- Ospedale di Cecina
- Divisione di Cardiologia - Azienda USL 12 di Viareggio
- Divisione Clinicizzata di Cardiologia - Az. Ospedaliera Maggiore della Carita
- Divisione di Cardiologia - ASL 22
- Divisione di Cardiologia - Azienda Ospedaliera Universitaria Pisana
- Divisione di Cardiologia - Azienda USL 4
- Divisione di Cardiologia - Ospedale Maria Vittoria
- Ospedalr di Verbania
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
1. VRS ON
2. VRS OFF
Patients with permanent atrial fibrillation implanted with VVI(R) pacemaker Vitatron model C20 SSIR or T20 SSIR were randomized to Function Ventricular Rate Stabilization (VRS) ON or OFF. This arm (1) is randomized to Function Ventricular Rate Stabilization ON.
Patients with permanent atrial fibrillation implanted with VVI(R) pacemaker Vitatron model C20 SSIR or T20 SSIR were randomized to Function Ventricular Rate Stabilization (VRS)ON or OFF. This arm (2) is randomized to Function Ventricular Rate Stabilization OFF.