Status:
COMPLETED
Sustained Treatment of Paroxysmal Atrial Fibrillation Post-Approval Study (STOP AF PAS)
Lead Sponsor:
Medtronic Cardiac Ablation Solutions
Conditions:
Paroxysmal Atrial Fibrillation (PAF)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The Post-Approval Study (PAS) is a prospective multi-center, non-randomized, single arm, controlled,unblinded clinical study designed to provide long-term safety and effectiveness of the Arctic Front®...
Detailed Description
Safety and effectiveness will be evaluated against pre-specified performance criteria as determined by the sponsor and FDA. The criteria set in this study have been previously used to demonstrate safe...
Eligibility Criteria
Inclusion
- Documented PAF:
- Diagnosis of paroxysmal atrial fibrillation (PAF), AND
- 2 or more episodes of AF during the 3 months preceding the consent Date, AND
- At least 1 episode of AF documented with a tracing within 12 months preceding the consent date.
- Age 18 years or older
- Failure for the treatment of AF (effectiveness or intolerance) of at least one membrane active AAD for rhythm control.
Exclusion
- Any previous left atrial (LA) ablation (except permissible retreatment subjects)
- Any previous LA surgery
- Current intracardiac thrombus (can be treated after thrombus is resolved)
- Presence of any pulmonary vein stents
- Presence of any pre-existing pulmonary vein stenosis
- Pre-existing hemidiaphragmatic paralysis
- Anteroposterior LA diameter \> 5.5 cm by TTE
- Presence of any cardiac valve prosthesis
- Clinically significant mitral valve regurgitation or stenosis
- Myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the Consent Date
- Unstable angina
- Any cardiac surgery which occurred during the 3 month interval preceding the Consent Date
- Any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
- NYHA class III or IV congestive heart failure
- Left ventricular ejection fraction (LVEF) \< 40%
- 2º (Type II) or 3º atrioventricular block
- Presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
- Brugada syndrome
- Long QT syndrome
- Arrhythmogenic right ventricular dysplasia
- Sarcoidosis
- Hypertrophic cardiomyopathy
- Known cryoglobulinemia
- Uncontrolled hyperthyroidism
- Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date.
- Any woman known to be pregnant
- Life expectancy less than one (1) year
- Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by Medtronic
- Unwilling or unable to comply fully with study procedures and followup
Key Trial Info
Start Date :
June 26 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2017
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT01456949
Start Date
June 26 2012
End Date
November 30 2017
Last Update
February 13 2025
Active Locations (39)
Enter a location and click search to find clinical trials sorted by distance.
1
Alaska Heart Institute
Anchorage, Alaska, United States, 99508
2
Banner Good Samaritan Medical Center
Phoenix, Arizona, United States, 85006
3
Good Samaritan Hospital
San Jose, California, United States, 95124
4
Colorado Heart and Vascular
Denver, Colorado, United States, 80204