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

Sponsor:	Mayo Clinic
Collaborator:	Medtronic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00589303

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 III

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

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Atrial Fibrillation Heart Failure

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

all cause mortality [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

health related quality of life measurements using validated instruments [ Time Frame: six months ] [ Designated as safety issue: No ]
atrial fibrillation symptoms assessment using Symptom Check List and AF Severity Scale [ Time Frame: six months ] [ Designated as safety issue: No ]
functional capacity by six minute walk [ Time Frame: six months ] [ Designated as safety issue: No ]
all cause hospitalization [ Time Frame: six months ] [ Designated as safety issue: No ]

Estimated Enrollment:	60
Study Start Date:	December 2007
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

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

Assigned Interventions

A: Active Comparator

Pharmacologic therapy for rate or rhythm control

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

B: Active Comparator

AV Node ablation and pacemaker implantation

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

Detailed Description:

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.

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.
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

Contacts and Locations

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

Contacts

Contact: Win K Shen, M.D.	507 255-2502	wshen@mayo.edu
Contact: Nancy Y Lexvold, R.N.	507-255-7013	lexvold.nancy@mayo.edu

Locations

United States, Arizona
Mayo Clinic Arizona	Recruiting
Scottsdale, Arizona, United States, 85259
Contact: Sarah N Briner 480-342-3484 briner.sarah@mayo.edu
Contact: Jacklyn D Gentry, RN 480-342-2906
Principal Investigator: Komandoor Srivathsan, MD
United States, Minnesota
Mayo Clinic	Recruiting
Rochester, Minnesota, United States, 55905
Contact: Celeste Koestler, RN 507-255-2200 koestler.celeste@mayo.edu
Contact: Jill M. Boyum 507 266-3180 boyum.jill@mayo.edu
Principal Investigator: Paul A Friedman, M.D.
Sub-Investigator: Win K. Shen, MD
United States, Oregon
Oregon Health and Science University	Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Elizabeth Cannard 503-494-5893 cannarde@oshu.edu
Principal Investigator: Eric Stecker, MD
Canada, Alberta
University of Calgary and Calgary Health Region	Recruiting
Calgary, Alberta, Canada, T2N-4N1
Contact: Sheilah Heal, RN 403-210-8381 heal@ucalgary.ca
Principal Investigator: Katherine Kavanaugh, MD

Sponsors and Collaborators

Mayo Clinic

Medtronic

Investigators

Principal Investigator:

Win K Shen, MD

Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

Publications:

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.

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.

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.

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.

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. No abstract available.

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:	Mayo Clinic ( Win K Shen MD )
Study ID Numbers:	06-004554
Study First Received:	December 21, 2007
Last Updated:	November 17, 2009
ClinicalTrials.gov Identifier:	NCT00589303 History of Changes
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:

Heart Failure
Pathologic Processes
Heart Diseases

Cardiovascular Diseases
Atrial Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on February 08, 2010