Back to results

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

Primary Purpose

Atrial Fibrillation, Heart Failure

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

FDA approved rate and rhythm control drugs

AV Node ablation and device implant

About this trial

This is an interventional treatment trial for Atrial Fibrillation focused on measuring Atrial Fibrillation, Heart Failure, AV Node ablation, Cardiac pacemaker, Antiarrhythmic drug

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mayo Clinic Arizona
The Heart Group
Mayo Clinic
Oregon Health and Science University
Chattanooga Heart Institute
University of Calgary and Calgary Health Region

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Drug Therapy

Atrioventricular Node (AVN) Ablation / Pacing

Arm Description

FDA approved rate and rhythm control drugs

AV Node ablation and device implant

Outcomes

Primary Outcome Measures

Cardiac Hospitalization Within Six Months of Enrollment

Number of patients who were hospitalized for cardiovascular problems within 6 months of enrollment.

Secondary Outcome Measures

Full Information

NCT ID

NCT00589303

First Posted

December 21, 2007

Last Updated

February 25, 2013

Sponsor

Mayo Clinic

Collaborators

Medtronic

1. Study Identification

Unique Protocol Identification Number

NCT00589303

Brief Title

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

Acronym

PACIFIC

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

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Terminated

Why Stopped

Lack of funding

Study Start Date

December 2007 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mayo Clinic

Collaborators

Medtronic

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation, Heart Failure

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

27 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Drug Therapy

Arm Type

Active Comparator

Arm Description

FDA approved rate and rhythm control drugs

Arm Title

Atrioventricular Node (AVN) Ablation / Pacing

Arm Type

Active Comparator

Arm Description

AV Node ablation and device implant

Intervention Type

Drug

Intervention Name(s)

FDA approved rate and rhythm control drugs

Other Intervention Name(s)

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

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

AV Node ablation and device implant

Intervention Description

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

Primary Outcome Measure Information:

Title

Cardiac Hospitalization Within Six Months of Enrollment

Description

Number of patients who were hospitalized for cardiovascular problems within 6 months of enrollment.

Time Frame

Six months after enrollment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Win K Shen, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic Arizona

City

Scottsdale

State/Province

Arizona

ZIP/Postal Code

85259

Country

United States

Facility Name

The Heart Group

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47710

Country

United States

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Facility Name

Oregon Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Chattanooga Heart Institute

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37404

Country

United States

Facility Name

University of Calgary and Calgary Health Region

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N-4N1

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

12466507

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.

Results Reference

background

PubMed Identifier

17275763

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.

Results Reference

background

PubMed Identifier

17259952

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.

Results Reference

background

PubMed Identifier

11287974

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.

Results Reference

background

PubMed Identifier

12379588

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.

Results Reference

background

PubMed Identifier

16908781

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. Erratum In: Circulation. 2007 Aug 7;116(6):e138.

Results Reference

background

Links:

URL

http://clinicaltrials.mayo.edu

Description

Mayo Clinic Clinical Trials

Learn more about this trial

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

We'll reach out to this number within 24 hrs