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Permanent Atrial FibrillationPhase 4RARE-PEARLNCT00246805

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

A Phase 4 study testing Vitatron pacemaker C20 SSIR or T20 SSIR models in people with Permanent Atrial Fibrillation, run by Medtronic BRC at 13 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Permanent Atrial Fibrillation
What is being tested?
Vitatron pacemaker C20 SSIR or T20 SSIR models
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
13 sitesItaly
Study dates
Jan 2006to Mar 2009
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

Italy13 sites

  • Divisione di Cardiologia - Ospedale Civile

    Acqui Terme, 15011

  • Divisione di Cardiologia - Az. Ospedaliera Umberto I

    Ancona, 60020

  • Divisione di Cardiologia - USL 8

    Arezzo, 52100

  • Divisione di Cardiologia- Ospedale di Cecina

    Cecina, 57023

  • Divisione di Cardiologia - Azienda USL 12 di Viareggio

    Lido di Camaiore, 55043

  • Divisione di Cardiologia - Ospedale Civile

    Livorno, LI, 57100

  • Divisione Clinicizzata di Cardiologia - Az. Ospedaliera Maggiore della Carita

    Novara, 28100

  • Divisione di Cardiologia - ASL 22

    Novi Ligure, 15067

  • Divisione di Cardiologia - Azienda Ospedaliera Universitaria Pisana

    Pisa, 56127

  • Divisione di Cardiologia - Azienda USL 4

    Prato, 59100

  • Divisione di Cardiologia - ospedale Civile

    Rieti, RI, 02100

  • Divisione di Cardiologia - Ospedale Maria Vittoria

    Torino, 10100

  • Ospedalr di Verbania

    Verbania

Other trials in Italy

About this study

Official title: 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).

Read the 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.

Being tested
Vitatron pacemaker C20 SSIR or T20 SSIR models
Keywords
Permanent atrial fibrillation, VVI(R) pacing, rate regularization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitatron pacemaker C20 SSIR or T20 SSIR modelsDevice

    VRS: special function that automatically adapts pacing rate to regularize cardiac cycles

Study groups in NCT00246805
Study groupRoleWhat they receive
1. VRS ONExperimentalPatients 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.
Receives: Device: Vitatron pacemaker C20 SSIR or T20 SSIR models
2. VRS OFFNo interventionPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: June 2009

Secondary outcomes (4)

  1. Evaluation of Rate Irregularity Indicators and Patient's Symptoms

    Measured: January 2009

  2. Number of Patients That Should Undergo Atrioventricular Nodal (AVN) Ablation

    Measured: January 2009

  3. Number of Patients That Should Undergo Drug Therapy in Combination With Pacing to Stabilize Heart Rate

    Measured: January 2009

  4. Potential Discomforts of Pacing Algorithm for Heart Rate Stabilization

    Measured: January 2009

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2005 (estimated)
  2. Study startJan 2006
  3. Primary completionJan 2009
  4. Study completionMar 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00246805
Sponsor's protocol ID
RARE-PEARL
Acronym
RARE-PEARL
Status last verified
Mar 2010
First submitted
28 Oct 2005
Last updated
28 Sep 2011
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 2449483

  • 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.

    PubMed 9558685

  • 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.

    PubMed 15121077

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Vitatron pacemaker C20 SSIR or T20 SSIR models in people with Permanent Atrial Fibrillation, run by Medtronic BRC at 13 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Sep 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patients Mode Preference (VRS ON, VRS OFF, NO PREFERENCE) (time frame: June 2009). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00246805, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2011.

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