Status:
COMPLETED
Continued Access Protocol
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Collaborating Sponsors:
Medtronic
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This Continued Access Protocol has been written to allow ongoing treatment of subjects at selected investigational sites while the marketing application for the Arctic Front® Cryoablation System is un...
Detailed Description
1. To evaluate the safety of treatment with the Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor® MAX Cardiac Cryoablation Catheter by assessing the continuous survival of sub...
Eligibility Criteria
Inclusion
- Subjects must fulfill ALL of the following criteria:
- Documented PAF:
- diagnosis of paroxysmal atrial fibrillation (PAF) (Section 9.1.18, General Protocol Terminology), AND
- 2 or more episodes of AF during the 3 months preceding the Consent Date, at least 1 of which must be documented with a tracing
- 18 and 75 years of age
- Failure for the treatment of AF (effectiveness or intolerance) of one or more of the following drugs indicated in the treatment of PAF: flecainide, propafenone, sotalol or dofetilide.
Exclusion
- ANY of the following is regarded as a criterion for excluding a subject from the study:
- 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
- Any woman without freedom from pregnancy as demonstrated by one or more of the following conditions:
- negative β-HCG test within 7 days prior to Start Date
- history of surgical sterilization
- postmenopausal and free of menses for at least 12 months.
- 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
- Unwilling or unable to comply fully with study procedures and follow-up
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00889681
Start Date
March 1 2009
End Date
October 1 2013
Last Update
September 19 2018
Active Locations (10)
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1
Banner Good Samaritan
Phoenix, Arizona, United States, 85006
2
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
3
Stanford Hospital & Clinical
Stanford, California, United States, 94305-5288
4
Bay Heart Group
Tampa, Florida, United States, 33607