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

Heart Failure Clinical Trial

— PACIFIC  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00589303
• Other study ID #: 06-004554
• Status: Terminated
• Phase: Phase 3
• First received: December 21, 2007
• Last updated: February 25, 2013
• Start date: December 2007
• Est. completion date: July 2011

Study information

• Verified date: February 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 27
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Failure

Intervention

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

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

Locations

Country	Name	City	State
Canada	University of Calgary and Calgary Health Region	Calgary	Alberta
United States	Chattanooga Heart Institute	Chattanooga	Tennessee
United States	The Heart Group	Evansville	Indiana
United States	Oregon Health and Science University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	Mayo Clinic Arizona	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Medtronic

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (6)

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. Epub 2006 Oct 20. — View 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. Review. — View Citation

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. Erratum in: Circulation. 2007 Aug 7;116(6):e138. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac Hospitalization Within Six Months of Enrollment	Number of patients who were hospitalized for cardiovascular problems within 6 months of enrollment.	Six months after enrollment	No

External Links

•   Mayo Clinic Clinical Trials