Heart Rate Regularization in Patients With Permanent Atrial Fibrillation Post Marketing Study

Permanent Atrial Fibrillation Clinical Trial

— RARE-PEARL  

Official title:

Post Marketing Study on Heart Rate Regularization in Patients With Permanent Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00246805
• Other study ID #: RARE-PEARL
• Status: Completed
• Phase: Phase 4
• First received: October 28, 2005
• Last updated: August 23, 2011
• Start date: January 2006
• Est. completion date: March 2009

Study information

• Verified date: March 2010
• Source: Medtronic BRC
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Institute of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: March 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Permanent Atrial Fibrillation

Intervention

Device:
• Vitatron pacemaker C20 SSIR or T20 SSIR models
VRS: special function that automatically adapts pacing rate to regularize cardiac cycles

Locations

Country	Name	City	State
Italy	Divisione di Cardiologia - Ospedale Civile	Acqui Terme
Italy	Divisione di Cardiologia - Az. Ospedaliera Umberto I	Ancona
Italy	Divisione di Cardiologia - USL 8	Arezzo
Italy	Divisione di Cardiologia- Ospedale di Cecina	Cecina
Italy	Divisione di Cardiologia - Azienda USL 12 di Viareggio	Lido di Camaiore
Italy	Divisione di Cardiologia - Ospedale Civile	Livorno	LI
Italy	Divisione Clinicizzata di Cardiologia - Az. Ospedaliera Maggiore della Carita	Novara
Italy	Divisione di Cardiologia - ASL 22	Novi Ligure
Italy	Divisione di Cardiologia - Azienda Ospedaliera Universitaria Pisana	Pisa
Italy	Divisione di Cardiologia - Azienda USL 4	Prato
Italy	Divisione di Cardiologia - ospedale Civile	Rieti	RI
Italy	Divisione di Cardiologia - Ospedale Maria Vittoria	Torino
Italy	Ospedalr di Verbania	Verbania

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic BRC	Medtronic

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. — View Citation

Mazzocca G, Giovannini T, Frascarelli F, Fabiani A, Burali A, Giappichini G, Bidi G, Bernabò 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. — View Citation

Proclemer A et al, Registro Italiano Pacemaker e Defibrillatori. Bollettino Periodico 2001. G Ital Aritmol Cardiostim 2002;5:5-31.

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE)	Evaluation of patient preference concerning the programming of a specific algorithm for automatic Ventricular Rate Stabilization (VRS): Algorithm ON vs. OFF.	June 2009	No
Secondary	Evaluation of Rate Irregularity Indicators and Patient's Symptoms		January 2009	No
Secondary	Number of Patients That Should Undergo Atrioventricular Nodal (AVN) Ablation		January 2009	No
Secondary	Number of Patients That Should Undergo Drug Therapy in Combination With Pacing to Stabilize Heart Rate		January 2009	No
Secondary	Potential Discomforts of Pacing Algorithm for Heart Rate Stabilization		January 2009	No