Clinical trial NCT00589303: AV Node Ablation and Pacemaker Therapy Compared to Drug Therapy for Atrial Fibrillation - Pilot Study
Official title: Pacing and AV Node Ablation Compared to Drug Therapy in Symptomatic Elderly Patients With Atrial Fibrillation Clinical Trial (PACIFIC) - Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Atrial Fibrillation
Heart Failure
Keywords: Atrial Fibrillation
Heart Failure
AV Node ablation
Cardiac pacemaker
Antiarrhythmic drug
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2008-01-09
Enrollment: 27
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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 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

Primary outcomes:
measure: Cardiac Hospitalization Within Six Months of Enrollment
timeFrame: Six months after enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Evansville
country: United States
facility: The Heart Group
state: Indiana
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Chattanooga
country: United States
facility: Chattanooga Heart Institute
state: Tennessee
city: Calgary
country: Canada
facility: University of Calgary and Calgary Health Region
state: Alberta
Study officials:
affiliation: Mayo Clinic
name: Win K Shen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Gelder IC, Hagens VE, Bosker HA, Kingma JH, Kamp O, Kingma T, Said SA, Darmanata JI, Timmermans AJ, Tijssen JG, Crijns HJ; Rate Control versus Electrical Cardioversion for Persistent Atrial Fibrillation Study Group. A comparison of rate control and rhythm control in patients with recurrent persistent atrial fibrillation. N Engl J Med. 2002 Dec 5;347(23):1834-40. doi: 10.1056/NEJMoa021375.
citation: Bradley DJ, Shen WK. Atrioventricular junction ablation combined with either right ventricular pacing or cardiac resynchronization therapy for atrial fibrillation: the need for large-scale randomized trials. Heart Rhythm. 2007 Feb;4(2):224-32. doi: 10.1016/j.hrthm.2006.10.016. Epub 2006 Oct 20.
citation: Bradley DJ, Shen WK. Overview of management of atrial fibrillation in symptomatic elderly patients: pharmacologic therapy versus AV node ablation. Clin Pharmacol Ther. 2007 Feb;81(2):284-7. doi: 10.1038/sj.clpt.6100062.
citation: Ozcan C, Jahangir A, Friedman PA, Patel PJ, Munger TM, Rea RF, Lloyd MA, Packer DL, Hodge DO, Gersh BJ, Hammill SC, Shen WK. Long-term survival after ablation of the atrioventricular node and implantation of a permanent pacemaker in patients with atrial fibrillation. N Engl J Med. 2001 Apr 5;344(14):1043-51. doi: 10.1056/NEJM200104053441403.
citation: Gregoratos G, Abrams J, Epstein AE, Freedman RA, Hayes DL, Hlatky MA, Kerber RE, Naccarelli GV, Schoenfeld MH, Silka MJ, Winters SL, Gibbons RJ, Antman EM, Alpert JS, Gregoratos G, Hiratzka LF, Faxon DP, Jacobs AK, Fuster V, Smith SC Jr; American College of Cardiology/American Heart Association Task Force on Practice Guidelines/North American Society for Pacing and Electrophysiology Committee to Update the 1998 Pacemaker Guidelines. ACC/AHA/NASPE 2002 guideline update for implantation of cardiac pacemakers and antiarrhythmia devices: summary article: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/NASPE Committee to Update the 1998 Pacemaker Guidelines). Circulation. 2002 Oct 15;106(16):2145-61. doi: 10.1161/01.cir.0000035996.46455.09. No abstract available.
citation: Fuster V, Ryden 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. doi: 10.1161/CIRCULATIONAHA.106.177292. No abstract available.