Status:
COMPLETED
Heart Rate Regularization in Patients With Permanent Atrial Fibrillation Post Marketing Study
Lead Sponsor:
Medtronic BRC
Collaborating Sponsors:
Medtronic
Conditions:
Permanent Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to monitor heart rate regularization in patients with permanent atrial fibrillation and standard indication for single chamber rate adaptive pacing VVI(R).
Detailed Description
The RARE PEARL is a multicenter prospective, randomized, double-blinded, crossover study. Prior entering the study the patient should be informed and should give his written consent. Besides he/she s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00246805
Start Date
January 1 2006
End Date
March 1 2009
Last Update
September 28 2011
Active Locations (13)
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1
Divisione di Cardiologia - Ospedale Civile
Livorno, LI, Italy, 57100
2
Divisione di Cardiologia - ospedale Civile
Rieti, RI, Italy, 02100
3
Divisione di Cardiologia - Ospedale Civile
Acqui Terme, Italy, 15011
4
Divisione di Cardiologia - Az. Ospedaliera Umberto I
Ancona, Italy, 60020