Official Title: “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 Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2009

Epidemiologic studies have shown that70-80% 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 (ACC/AHA 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.

Intervention(s) in this Clinical Trial

• 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 physicians discretion. Rate Control: Beta-Blocker metoprolol atenolol carvedilol Calcium Channel Blocked verapamil diltiazem Rhythm Control: procainamide quinidine disopyramide propafenone flecainide sotalol dofetilide amiodarone
• Device: AV Node ablation and device implant
  • Pacing Systems Enpusle PMA # P980035 EnRhythm PMA # P980035 Adapta PMA # P980035 CRT Pacing Systems InSync III/ Insync Maximo/InSyncII Marquis PMA # P010031 ICD Pacing Systems EnTrust PMA # P980016 Virtuoso PMA # P980016 ICD CRT Pacing Systems InSync Maximo PMA: P980016 InSync Sentry PMA: P890003 Concerto PMA: P980016

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • Pharmacologic therapy for rate or rhythm control
• Active Comparator: B
  • AV Node ablation and pacemaker implantation

Primary Measures

• all cause mortality
  • Time Frame: six months
    Safety Issue?: No

Secondary Measures

• health related quality of life measurements using validated instruments
  • Time Frame: six months
    Safety Issue?: No
• atrial fibrillation symptoms assessment using Symptom Check List and AF Severity Scale
  • Time Frame: six months
    Safety Issue?: No
• functional capacity by six minute walk
  • Time Frame: six months
    Safety Issue?: No
• all cause hospitalization
  • Time Frame: six months
    Safety Issue?: No

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.
• One and only 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, 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 tachycardia)
• 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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 65 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Mayo Clinic

Overall Clinical Trial Officials and Contacts

Win K Shen, MD Principal Investigator Mayo Clinic  

Overall Contact: Win K Shen, M.D. 507 255-2502 wshen@mayo.edu

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00589303

Study ID Number: 06-004554

ClinicalTrials.gov Identifier: NCT00589303

Health Authority: United States: Food and Drug Administration

Mayo Clinic Clinical Trials