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

This study has been terminated.
(Lack of funding)
Sponsor:
Collaborator:
Medtronic
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00589303
First received: December 21, 2007
Last updated: February 25, 2013
Last verified: February 2013
  Purpose

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).


Condition Intervention Phase
Atrial Fibrillation
Heart Failure
Drug: FDA approved rate and rhythm control drugs
Device: AV Node ablation and device implant
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pacing and AV Node Ablation Compared to Drug Therapy in Symptomatic Elderly Patients With Atrial Fibrillation Clinical Trial (PACIFIC) - Pilot Study

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Cardiac Hospitalization Within Six Months of Enrollment [ Time Frame: Six months after enrollment ] [ Designated as safety issue: No ]
    Number of patients who were hospitalized for cardiovascular problems within 6 months of enrollment.


Enrollment: 27
Study Start Date: December 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Lopressor
  • Toprol XL
  • Tenormin
  • Coreg
  • Isoptin
  • Verelan
  • Verelan PM
  • Calan
  • Bosoptin
  • Covera-HS
  • Cardizem
  • Pronestyl
  • Norpace
  • Rythmol
  • Betapace
  • Tikosyn
  • Cordarone
  • Pacerone
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

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.
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00589303

Locations
United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
United States, Indiana
The Heart Group
Evansville, Indiana, United States, 47710
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Tennessee
Chattanooga Heart Institute
Chattanooga, Tennessee, United States, 37404
Canada, Alberta
University of Calgary and Calgary Health Region
Calgary, Alberta, Canada, T2N-4N1
Sponsors and Collaborators
Mayo Clinic
Medtronic
Investigators
Principal Investigator: Win K Shen, MD Mayo Clinic
  More Information

Additional Information:
Publications:
Fuster V, Rydén LE, Cannom DS, Crijns HJ, Curtis AB, Ellenbogen KA, Halperin JL, Le Heuzey JY, Kay GN, Lowe JE, Olsson SB, Prystowsky EN, Tamargo JL, Wann S, Smith SC Jr, Jacobs AK, Adams CD, Anderson JL, Antman EM, Halperin JL, Hunt SA, Nishimura R, Ornato JP, Page RL, Riegel B, Priori SG, Blanc JJ, Budaj A, Camm AJ, Dean V, Deckers JW, Despres C, Dickstein K, Lekakis J, McGregor K, Metra M, Morais J, Osterspey A, Tamargo JL, Zamorano JL; American College of Cardiology/American Heart Association Task Force on Practice Guidelines; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 Guidelines for the Management of Patients with Atrial Fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Revise the 2001 Guidelines for the Management of Patients With Atrial Fibrillation): developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Circulation. 2006 Aug 15;114(7):e257-354. No abstract available. Erratum in: Circulation. 2007 Aug 7;116(6):e138.

Responsible Party: Win K Shen MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00589303     History of Changes
Other Study ID Numbers: 06-004554
Study First Received: December 21, 2007
Results First Received: February 25, 2013
Last Updated: February 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Atrial Fibrillation
Heart Failure
AV Node ablation
Cardiac pacemaker
Antiarrhythmic drug

Additional relevant MeSH terms:
Atrial Fibrillation
Heart Failure
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 24, 2014