Heart Rate Regularization in Patients With Permanent Atrial Fibrillation Post Marketing Study
NCT ID: NCT00246805
Last Updated: 2011-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
67 participants
INTERVENTIONAL
2006-01-31
2009-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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1. VRS 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 (1) is randomized to Function Ventricular Rate Stabilization ON.
Vitatron pacemaker C20 SSIR or T20 SSIR models
VRS: special function that automatically adapts pacing rate to regularize cardiac cycles
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 (2) is randomized to Function Ventricular Rate Stabilization OFF.
No interventions assigned to this group
Interventions
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Vitatron pacemaker C20 SSIR or T20 SSIR models
VRS: special function that automatically adapts pacing rate to regularize cardiac cycles
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Medtronic BRC
INDUSTRY
Responsible Party
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Principal Investigators
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Giorgio Corbucci, PhD
Role: STUDY_DIRECTOR
Vitatron Medical Italia
Eraldo Occhetta, MD
Role: PRINCIPAL_INVESTIGATOR
Ospedale Maggiore della Misericordia - Novara
Gianfranco Mazzocca, MD
Role: PRINCIPAL_INVESTIGATOR
Ospedale di Cecina (LI)
Locations
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Divisione di Cardiologia - Ospedale Civile
Livorno, LI, Italy
Divisione di Cardiologia - ospedale Civile
Rieti, RI, 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 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 Maria Vittoria
Torino, , Italy
Ospedalr di Verbania
Verbania, , Italy
Countries
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References
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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. doi: 10.1016/0735-1097(88)91528-8.
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.
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.
Other Identifiers
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RARE-PEARL
Identifier Type: -
Identifier Source: org_study_id