Heart Rate Regularization in Patients With Permanent Atrial Fibrillation Post Marketing Study
Heart Rate Regularization in Patients With Permanent Atrial Fibrillation Post Marketing Study
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).
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 should meet all selection criteria. The Investigator has to check that all
 selection criteria are satisfied. Then the patient undergoes pacemaker implantation,
 receiving a pacemaker model C20 SSIR or T20 SSIR (or later). The ventricular lead must be
 bipolar independently of the manufacturer.

 After pacemaker implantation, a 45 days Stabilization Period is necessary to stabilize leads
 and drug therapy.

 At the end of the stabilization period the patient is randomized to have VRS algorithm
 switched either ON or OFF. The 1° Study Phase ends after 2 months. Then a cross-over takes
 place: VRS algorithm is switched respectively OFF or ON and the 2° Study Phase is started.
 Also the 2° Study Phase ends after 2 months.

 The randomization will be centralized: randomization lists will be generated and managed by
 the sponsor. Because the patients will undergo a QoL questionnaire at each crossover phase,
 they will have to be blinded about the status of their VRS setting. Similarly, also the
 co-investigators administering the QoL questionnaires have to be blinded about the status of
 VRS setting. Only the principal investigator knows if the VRS algorithm is ON or OFF. The
 principal investigator will be instructed not to inform the patient and the co-investigators
 administering QoL questionnaire about the setting until after the end of the study.

 The co-investigator(s) responsible for QoL questionnaire should not perform the patient
 follow-up at 1° and 2° Study Phase, otherwise the patient is automatically excluded from the
 study.

 After the cross-over period (2 + 2 months) a Free Therapy Phase (3° Phase) starts. Device
 settings and drug therapy are left to the physician's discretion.

 One year after implantation a final follow-up is scheduled. The study ends and the pacemaker
 can be programmed according to the physician's discretion.
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