Heart Rate Regularization in Patients With Permanent Atrial Fibrillation Post Marketing Study (RARE-PEARL)
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|ClinicalTrials.gov Identifier: NCT00246805|
Recruitment Status : Completed
First Posted : October 30, 2005
Results First Posted : September 28, 2011
Last Update Posted : September 28, 2011
|Condition or disease||Intervention/treatment||Phase|
|Permanent Atrial Fibrillation||Device: Vitatron pacemaker C20 SSIR or T20 SSIR models||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Post Marketing Study on Heart Rate Regularization in Patients With Permanent Atrial Fibrillation|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||January 2009|
|Actual Study Completion Date :||March 2009|
Experimental: 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.
Device: Vitatron pacemaker C20 SSIR or T20 SSIR models
VRS: special function that automatically adapts pacing rate to regularize cardiac cycles
No Intervention: 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.
- Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE) [ Time Frame: June 2009 ]Evaluation of patient preference concerning the programming of a specific algorithm for automatic Ventricular Rate Stabilization (VRS): Algorithm ON vs. OFF.
- Evaluation of Rate Irregularity Indicators and Patient's Symptoms [ Time Frame: January 2009 ]
- Number of Patients That Should Undergo Atrioventricular Nodal (AVN) Ablation [ Time Frame: January 2009 ]
- Number of Patients That Should Undergo Drug Therapy in Combination With Pacing to Stabilize Heart Rate [ Time Frame: January 2009 ]
- Potential Discomforts of Pacing Algorithm for Heart Rate Stabilization [ Time Frame: January 2009 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246805
|Divisione di Cardiologia - Ospedale Civile|
|Livorno, LI, Italy, 57100|
|Divisione di Cardiologia - ospedale Civile|
|Rieti, RI, Italy, 02100|
|Divisione di Cardiologia - Ospedale Civile|
|Acqui Terme, Italy, 15011|
|Divisione di Cardiologia - Az. Ospedaliera Umberto I|
|Ancona, Italy, 60020|
|Divisione di Cardiologia - USL 8|
|Arezzo, Italy, 52100|
|Divisione di Cardiologia- Ospedale di Cecina|
|Cecina, Italy, 57023|
|Divisione di Cardiologia - Azienda USL 12 di Viareggio|
|Lido di Camaiore, Italy, 55043|
|Divisione Clinicizzata di Cardiologia - Az. Ospedaliera Maggiore della Carita|
|Novara, Italy, 28100|
|Divisione di Cardiologia - ASL 22|
|Novi Ligure, Italy, 15067|
|Divisione di Cardiologia - Azienda Ospedaliera Universitaria Pisana|
|Pisa, Italy, 56127|
|Divisione di Cardiologia - Azienda USL 4|
|Prato, Italy, 59100|
|Divisione di Cardiologia - Ospedale Maria Vittoria|
|Torino, Italy, 10100|
|Ospedalr di Verbania|
|Study Director:||Giorgio Corbucci, PhD||Vitatron Medical Italia|
|Principal Investigator:||Eraldo Occhetta, MD||Ospedale Maggiore della Misericordia - Novara|
|Principal Investigator:||Gianfranco Mazzocca, MD||Ospedale di Cecina (LI)|