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

August 23, 2011 updated by: Medtronic BRC

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

67

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Acqui Terme, Italy, 15011
        • Divisione di Cardiologia - Ospedale Civile
      • Ancona, Italy, 60020
        • Divisione di Cardiologia - Az. Ospedaliera Umberto I
      • Arezzo, Italy, 52100
        • Divisione di Cardiologia - USL 8
      • Cecina, Italy, 57023
        • Divisione di Cardiologia- Ospedale di Cecina
      • Lido di Camaiore, Italy, 55043
        • Divisione di Cardiologia - Azienda USL 12 di Viareggio
      • Novara, Italy, 28100
        • Divisione Clinicizzata di Cardiologia - Az. Ospedaliera Maggiore della Carita
      • Novi Ligure, Italy, 15067
        • Divisione di Cardiologia - ASL 22
      • Pisa, Italy, 56127
        • Divisione di Cardiologia - Azienda Ospedaliera Universitaria Pisana
      • Prato, Italy, 59100
        • Divisione di Cardiologia - Azienda USL 4
      • Torino, Italy, 10100
        • Divisione di Cardiologia - Ospedale Maria Vittoria
      • Verbania, Italy
        • Ospedalr di Verbania
    • LI
      • Livorno, LI, Italy, 57100
        • Divisione di Cardiologia - Ospedale Civile
    • RI
      • Rieti, RI, Italy, 02100
        • Divisione di Cardiologia - Ospedale Civile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
June 2009

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic BRC

Collaborators

Medtronic

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

March 1, 2009

Study Registration Dates

First Submitted

October 28, 2005

First Submitted That Met QC Criteria

October 28, 2005

First Posted (Estimate)

October 30, 2005

Study Record Updates

Last Update Posted (Estimate)

September 28, 2011

Last Update Submitted That Met QC Criteria

August 23, 2011

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RARE-PEARL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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