AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot Study (PACIFIC)

February 25, 2013 updated by: Mayo Clinic

Pacing and AV Node Ablation Compared to Drug Therapy in Symptomatic Elderly Patients With Atrial Fibrillation Clinical Trial (PACIFIC) - Pilot Study

The purpose of this study is to determine whether early atrioventricular node (AVN) ablation with pacing device therapy will reduce death and hospitalization when compared to the conventional drug therapy in elderly patients with recurrent and symptomatic atrial fibrillation (AF).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Epidemiologic studies have shown that 70-80% of patients with atrial fibrillation are older than 65 years of age. Drug therapy for atrial fibrillation is not effective or not tolerated in many elderly patients, for both rate or rhythm strategies. Preliminary data from AVN ablation and pacemaker therapy demonstrated this strategy is highly effective in controlling symptoms among patients who have failed numerous drug therapy. Quality of life is improved while hospital admission and office visits are reduced.

Pilot Study Design

  • All patients will be 1:1 randomized to standard-care drug therapy (American College of Cardiology/American Heart Association Guideline, 2006) or AV node ablation and pacemaker therapy
  • For patients randomized to AVN ablation, there will be a 1:1 sub-randomization to conventional right ventricular apex pacing or cardiac resynchronization therapy (biventricular pacing)
  • All patients will be followed at 2 and 6 months from the time of randomization in the pilot study.
  • A total of 60 patients from 5-15 clinical sites will be enrolled during an active recruiting period of 12 months for the pilot study.

Study Type

Interventional

Enrollment (Actual)

27

Phase

  • Phase 3

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N-4N1
        • University of Calgary and Calgary Health Region
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Mayo Clinic Arizona
    • Indiana
      • Evansville, Indiana, United States, 47710
        • The Heart Group
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Heart Institute

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

63 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age greater than or equal to 65 years
  • Paroxysmal, persistent, or permanent atrial fibrillation
  • Index event of atrial fibrillation is documented on electrocardiogram or rhythm strip. Atrial fibrillation must be the qualifying event. Atrial flutter can have been present in the past, but it must not be considered the index arrhythmia.
  • Paroxysmal atrial fibrillation episodes must be recurrent (two or more episodes in the past 6 months). At least one of the paroxysmal episodes must be "sustained", defined as lasting greater than 1 hour documented by a Holter monitor or by history in conjunction with an ECG or a rhythm strip.
  • At least one attempt of unsuccessful drug therapy, either for rate, for rhythm, or for rate-and-rhythm control.
  • Symptoms related to atrial fibrillation within the last 6 months
  • Eligible for long-term treatment with both treatment strategies
  • Must provide informed consent, Health Insurance Portability and Accountability Act (HIPAA) authorization, and be willing to comply with follow-up requirements.

Exclusion Criteria:

  • Reversible causes of atrial fibrillation
  • On heart transplant list
  • Familial cardiac conditions with increased risk of sudden death
  • Asymptomatic
  • Medical condition limiting expected survival to be less than one year
  • Contraindications to anticoagulation
  • Pre-existing implanted pacemaker, implantable automatic cardioverter-defibrillator or cardiac resynchronization device.
  • Pre-existing indication for permanent pacemaker, implantable automatic cardioverter-defibrillator or cardiac resynchronization device
  • More than one attempt of drug therapy for rate, for rhythm, or for rate-and-rhythm control
  • Planned major surgery within the next six months, including thoracic surgery
  • Disability that would preclude collection of study data or have co-morbidity that would contraindicate device implantation
  • Participated in another clinical trial within the previous 30 days using a therapeutic modality which could have potential residual effects that might confound the results of this pilot study
  • Unable to provide informed consent

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Drug Therapy
FDA approved rate and rhythm control drugs
Drug: FDA approved rate and rhythm control drugs

Any approved rate or rhythm control drugs for treatment of atrial fibrillation may be prescribed under the primary physician's discretion.

Rate Control:

Beta-Blocker:

  • metoprolol
  • atenolol
  • carvedilol

Calcium Channel Blocker:

  • verapamil
  • diltiazem

Rhythm Control:

  • procainamide
  • quinidine
  • disopyramide
  • propafenone
  • flecainide
  • sotalol
  • dofetilide
  • amiodarone
Other Names:
  • Cordarone
  • Tenormin
  • Coreg
  • Lopressor
  • Tikosyn
  • Betapace
  • Pacerone
  • Pronestyl
  • Covera-HS
  • Verelan PM
  • Cardizem
  • Calan
  • Toprol XL
  • Isoptin
  • Verelan
  • Bosoptin
  • Norpace
  • Rythmol
Active Comparator: Atrioventricular Node (AVN) Ablation / Pacing
AV Node ablation and device implant
Device: AV Node ablation and device implant

Pacing Systems:

  • Enpusle Premarket Approval Number (PMA#) P980035
  • EnRhythm PMA# P980035
  • Adapta PMA# P980035

Cardiac Resynchronization Therapy (CRT) Pacing Systems:

- InSync III/ Insync Maximo/InSyncII Marquis PMA# P010031

Implantable Cardioverter-Defibrillator (ICD) Pacing Systems:

  • EnTrust PMA# P980016
  • Virtuoso PMA# P980016

ICD CRT Pacing Systems:

  • InSync Maximo PMA# P980016
  • InSync Sentry PMA# P890003
  • Concerto PMA# P980016

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiac Hospitalization Within Six Months of Enrollment
Time Frame: Six months after enrollment
Number of patients who were hospitalized for cardiovascular problems within 6 months of enrollment.
Six months after enrollment

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Collaborators

Medtronic

Investigators

  • Principal Investigator: Win K Shen, MD, Mayo Clinic

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

Helpful Links

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

December 1, 2007

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

January 7, 2008

First Posted (Estimate)

January 9, 2008

Study Record Updates

Last Update Posted (Estimate)

April 4, 2013

Last Update Submitted That Met QC Criteria

February 25, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-004554

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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