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

This study has been terminated.

(Lack of funding)

Sponsor:

Collaborator:

Medtronic

Information provided by:

Mayo Clinic

ClinicalTrials.gov Identifier:

NCT00589303

First received: December 21, 2007

Last updated: February 25, 2013

Last verified: February 2013

History of Changes

Results First Received: February 25, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Atrial Fibrillation Heart Failure
Interventions:	Drug: FDA approved rate and rhythm control drugs Device: AV Node ablation and device implant

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from 5 sites: (Mayo Clinic in Scottsdale, Arizona; Mayo Clinic in Rochester, Minnesota; Oregon Health and Science University in Portland, Oregon; University of Calgary in Calgary, Alberta, Canada; and The Heart Group in Evansville, Indiana.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Drug Therapy	FDA approved rate and rhythm control drugs
Atrioventricular Node (AVN) Ablation / Pacing	Atrioventricular Node ablation and device implant

Participant Flow: Overall Study

	Drug Therapy	Atrioventricular Node (AVN) Ablation / Pacing
STARTED	14	13
COMPLETED	12	12
NOT COMPLETED	2	1
Withdrawal by Subject	2	1

Baseline Characteristics

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Reporting Groups

	Description
Drug Therapy	FDA approved rate and rhythm control drugs
Atrioventricular Node (AVN) Ablation / Pacing	Atrioventricular Node ablation and device implant
Total	Total of all reporting groups

Baseline Measures

	Drug Therapy	Atrioventricular Node (AVN) Ablation / Pacing	Total
Number of Participants [units: participants]	14	13	27
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	0	0	0
>=65 years	14	13	27
Gender [units: participants]
Female	8	6	14
Male	6	7	13
Region of Enrollment [units: participants]
United States	12	11	23
Canada	2	2	4

Outcome Measures

1. Primary:

Cardiac Hospitalization Within Six Months of Enrollment [ Time Frame: Six months after enrollment ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The study was terminated when about half of the subjects were enrolled due to lack of funding.

Results Point of Contact:

Name/Title: Dr. Win K. Shen
Organization: Mayo Clinic
phone: 480-342-0348
e-mail: wshen@mayo.edu

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:	Win K Shen MD, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00589303 History of Changes
Other Study ID Numbers:	06-004554
Study First Received:	December 21, 2007
Results First Received:	February 25, 2013
Last Updated:	February 25, 2013
Health Authority:	United States: Food and Drug Administration

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