Lack of funding
PACIFIC
Pacing and AV Node Ablation Compared to Drug Therapy in Symptomatic Elderly Patients With Atrial Fibrillation Clinical Trial (PACIFIC) - Pilot Study
Sponsor study identifier
interventional
27
2 countries
6
Study Start
December 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2011
Actual (reported)Study Completion
July 2011
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2007
Date type not reportedThis date has not been verified as actual or estimated.
December 21, 2007
Actual (reported)January 9, 2008
Actual (reported)July 2011
Actual (reported)July 2011
Actual (reported)April 4, 2013
Actual (reported)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
FDA approved rate and rhythm control drugs
AV Node ablation and device implant
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
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
The Heart Group
Evansville, Indiana, 47710, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Chattanooga Heart Institute
Chattanooga, Tennessee, 37404, United States
University of Calgary and Calgary Health Region
Calgary, Alberta, T2N-4N1, Canada
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.
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.
The study was terminated when about half of the subjects were enrolled due to lack of funding.
Win K Shen, MD
Mayo Clinic
27 participants (actual enrollment reported by the registry).
First Submitted
December 21, 2007
First Posted
January 9, 2008
Study Start
December 2007
Date type not reportedThis date has not been verified as actual or estimated.
AtriCure Bipolar Radiofrequency Ablation of Permanent Atrial Fibrillation
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
Primary Completion
July 2011
Actual (reported)Study Completion
July 2011
Actual (reported)Last Updated
April 4, 2013
Results First Posted
April 4, 2013
Record last verified: 2013-02
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Source: ClinicalTrials.gov.
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