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

NCT00589303 | Terminated Phase 3 Results DMC

• 1 other identifier: 06-004554
• Study Type: interventional
• Target: 27
• Locations: 2 countries
• Sites: 6

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).

Conditions

Atrial Fibrillation; Heart Failure

Keywords

Atrial Fibrillation; Heart Failure; AV Node ablation; Cardiac pacemaker; Antiarrhythmic drug

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Drug Therapy

ACTIVE COMPARATOR

FDA approved rate and rhythm control drugs

Drug: FDA approved rate and rhythm control drugs

Atrioventricular Node (AVN) Ablation / Pacing

ACTIVE COMPARATOR

AV Node ablation and device implant

Device: AV Node ablation and device implant

Interventions

FDA approved rate and rhythm control drugs DRUG

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

Also known as: Lopressor, Toprol XL, Tenormin, Coreg, Isoptin, Verelan, Verelan PM, Calan, Bosoptin, Covera-HS, Cardizem, Pronestyl, Norpace, Rythmol, Betapace, Tikosyn, Cordarone, Pacerone

Drug Therapy

AV Node ablation and device implant DEVICE

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

Atrioventricular Node (AVN) Ablation / Pacing

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• Medtronic: collaborator

Study Sites (6)

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

The Heart Group

Evansville, Indiana, 47710, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Chattanooga Heart Institute

Chattanooga, Tennessee, 37404, United States

Location

University of Calgary and Calgary Health Region

Calgary, Alberta, T2N-4N1, Canada

Location

Related Publications (6)

• 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.

  PMID: 12466507 BACKGROUND

• 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.

  PMID: 17275763 BACKGROUND

• 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.

  PMID: 17259952 BACKGROUND

• 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.

  PMID: 11287974 BACKGROUND

• 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.

  PMID: 12379588 BACKGROUND

• 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.

  PMID: 16908781 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation; Heart Failure

Interventions

Metoprolol; Atenolol; Carvedilol; Verapamil; Diltiazem; Procainamide; Disopyramide; Propafenone; Sotalol; dofetilide; Amiodarone; Equipment and Supplies

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring; Phenethylamines; Ethylamines; Benzazepines; Benzamides; Amides; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pyridines; Heterocyclic Compounds, 1-Ring; Propiophenones; Ketones; Ethanolamines; Benzofurans

Limitations and Caveats

The study was terminated when about half of the subjects were enrolled due to lack of funding.

Results Point of Contact

• Title: Dr. Win K. Shen
• Organization: Mayo Clinic

wshen@mayo.edu

480-342-0348

Study Officials

• Win K Shen, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 9, 2008
• Study Start: December 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: April 4, 2013
• Results First Posted: April 4, 2013

Record last verified: 2013-02

Locations

CA (1); US (5)