Clinical trial NCT00246805: Heart Rate Regularization in Patients With Permanent Atrial Fibrillation Post Marketing Study
Official title: Post Marketing Study on Heart Rate Regularization in Patients With Permanent Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Permanent Atrial Fibrillation
Keywords: Permanent atrial fibrillation
VVI(R) pacing
rate regularization
Lead sponsor: Medtronic BRC
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2005-10-30
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.

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

Primary outcomes:
measure: Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE)
timeFrame: June 2009
Secondary outcomes:
measure: Evaluation of Rate Irregularity Indicators and Patient's Symptoms
timeFrame: January 2009
measure: Number of Patients That Should Undergo Atrioventricular Nodal (AVN) Ablation
timeFrame: January 2009
measure: Number of Patients That Should Undergo Drug Therapy in Combination With Pacing to Stabilize Heart Rate
timeFrame: January 2009
measure: Potential Discomforts of Pacing Algorithm for Heart Rate Stabilization
timeFrame: January 2009
Other outcomes:
Locations:
city: Livorno
country: Italy
facility: Divisione di Cardiologia - Ospedale Civile
state: LI
city: Rieti
country: Italy
facility: Divisione di Cardiologia - ospedale Civile
state: RI
city: Acqui Terme
country: Italy
facility: Divisione di Cardiologia - Ospedale Civile
city: Ancona
country: Italy
facility: Divisione di Cardiologia - Az. Ospedaliera Umberto I
city: Arezzo
country: Italy
facility: Divisione di Cardiologia - USL 8
city: Cecina
country: Italy
facility: Divisione di Cardiologia- Ospedale di Cecina
city: Lido di Camaiore
country: Italy
facility: Divisione di Cardiologia - Azienda USL 12 di Viareggio
city: Novara
country: Italy
facility: Divisione Clinicizzata di Cardiologia - Az. Ospedaliera Maggiore della Carita
city: Novi Ligure
country: Italy
facility: Divisione di Cardiologia - ASL 22
city: Pisa
country: Italy
facility: Divisione di Cardiologia - Azienda Ospedaliera Universitaria Pisana
city: Prato
country: Italy
facility: Divisione di Cardiologia - Azienda USL 4
city: Torino
country: Italy
facility: Divisione di Cardiologia - Ospedale Maria Vittoria
city: Verbania
country: Italy
facility: Ospedalr di Verbania
Study officials:
affiliation: Vitatron Medical Italia
name: Giorgio Corbucci, PhD
role: STUDY_DIRECTOR
affiliation: Ospedale Maggiore della Misericordia - Novara
name: Eraldo Occhetta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ospedale di Cecina (LI)
name: Gianfranco Mazzocca, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Proclemer A et al, Registro Italiano Pacemaker e Defibrillatori. Bollettino Periodico 2001. G Ital Aritmol Cardiostim 2002;5:5-31.
citation: Wittkampf FH, de Jongste MJ, Lie HI, Meijler FL. Effect of right ventricular pacing on ventricular rhythm during atrial fibrillation. J Am Coll Cardiol. 1988 Mar;11(3):539-45. doi: 10.1016/0735-1097(88)91528-8.
citation: Lau CP, Jiang ZY, Tang MO. Efficacy of ventricular rate stabilization by right ventricular pacing during atrial fibrillation. Pacing Clin Electrophysiol. 1998 Mar;21(3):542-8. doi: 10.1111/j.1540-8159.1998.tb00096.x.
citation: Mazzocca G, Giovannini T, Frascarelli F, Fabiani A, Burali A, Giappichini G, Bidi G, Bernabo D, Manfredini E, Corbucci G. Heart rate regularisation in patients with permanent atrial fibrillation implanted with a VVI(R) pacemaker. Europace. 2004 May;6(3):236-42. doi: 10.1016/j.eupc.2004.02.002.