A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation

PHASE3CompletedINTERVENTIONAL
Enrollment

245

Participants

Timeline

Start Date

October 31, 2006

Primary Completion Date

August 31, 2010

Study Completion Date

July 31, 2011

Conditions
Paroxysmal Atrial Fibrillation
Interventions
DEVICE

Arctic Front® Cryoablation Catheter

Experimental Subjects received cryoablation intended to isolate the pulmonary veins and ablate arrhythmia foci with the cryoablation catheter system.

DRUG

Flecainide or Sotalol or Propafenone

Flecainide 200 mg / day Propafenone 450 mg / day Propafenone-SR 650 mg / day Sotalol 240 mg / day

Trial Locations (26)

10467

Montefiore Medical Center, The Bronx

22042

Inova Research Center, Falls Church

23219

Medical College of Virginia, Richmond

23507

Sentara CV Research Institute, Norfolk

30308

Emery Crawford Long Hospital, Atlanta

30309

Piedmont Hospital, Atlanta

32224

Mayo Clinic- Jacksonville, Jacksonville

33607

BayHeart Group -- St-Joseph's Hospital, Tampa

44195

Cleveland Clinic Foundation, Cleveland

50314

Iowa Heart Center, Des Moines

53215

Arrhythmia Center of Southern WI, Milwaukee

55902

Mayo Clinic, Rochester

75226

Baylor Heart and Vascular Hospital, Dallas

80907

Colorado Cardiac Alliance -- Memorial Hospital, Colorado Springs

85006

Banner Good Samaritan Medical Center, Phoenix

87102

New Mexico Heart Institute, Albuquerque

90048

Cedar Sinai Medical Center, Los Angeles

98517

UC Davis Medical Center, Sacramento

35294-0007

University of Alabama, Birmingham

94305-5233

Stanford Hospital, Stanford

02114

Massachusetts General Hospital, Boston

19104-4283

University of Pennsylvania Health, Philadelphia

54301-3596

Cardiology Associates of Green Bay, Green Bay

N6A5A5

London Medical Health Sciences, London

H1T 1C8

Montreal Heart Institute, Montreal

G1V 4G5

Laval Hospital, Ste-Foy

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medtronic

INDUSTRY

lead

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

NCT00523978 - A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation | Biotech Hunter | Biotech Hunter