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Heart Rate Regularization in Patients With Permanent Atrial Fibrillation Post Marketing Study (RARE-PEARL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00246805
Recruitment Status : Completed
First Posted : October 30, 2005
Results First Posted : September 28, 2011
Last Update Posted : September 28, 2011
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic BRC

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).

Condition or disease Intervention/treatment Phase
Permanent Atrial Fibrillation Device: Vitatron pacemaker C20 SSIR or T20 SSIR models Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 67 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Evaluation of Rate Irregularity Indicators and Patient's Symptoms [ Time Frame: January 2009 ]
  2. Number of Patients That Should Undergo Atrioventricular Nodal (AVN) Ablation [ Time Frame: January 2009 ]
  3. Number of Patients That Should Undergo Drug Therapy in Combination With Pacing to Stabilize Heart Rate [ Time Frame: January 2009 ]
  4. Potential Discomforts of Pacing Algorithm for Heart Rate Stabilization [ Time Frame: January 2009 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Italy
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
Verbania, Italy
Sponsors and Collaborators
Medtronic BRC
Medtronic
Investigators
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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)

Publications:
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Responsible Party: Medtronic BRC
ClinicalTrials.gov Identifier: NCT00246805    
Other Study ID Numbers: RARE-PEARL
First Posted: October 30, 2005    Key Record Dates
Results First Posted: September 28, 2011
Last Update Posted: September 28, 2011
Last Verified: March 2010
Keywords provided by Medtronic BRC:
Permanent atrial fibrillation
VVI(R) pacing
rate regularization
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes