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A multi-center, randomized, controlled study of cryoablation vs medical management for the treatment of PAF
The purpose of this prospective, randomized multi-center clinical study is to establish the benefits of the CryoCor(TM) Cardiac Cryoablation System for treating symptomatic paroxysmal atrial fibrillation (PAF) in comparison to treatment with anti-arrhythmic medications alone. This study also evaluates the safety profile of the CryoCor(TM) Cardiac Cryoablation System when used in this same setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with CryoCor Cryoablation System | Active Comparator | Intervention includes ablation therapy with the CryoCor catheter for the treatment of symptomatic PAF. |
|
| Treatment with standard medical therapy | Active Comparator | Intervention includes treatment with ant-arrhythmic medications alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac CryoCor Cryoablation System | Device | Treatment with CryoCor Cardiac Cryoablation system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety profile of intervention | 12 months | |
| Recurrence of PAF | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in QOL as measured by SF-36 Health Survey | Changes compared to baseline will be measured over a period of 12 months | 12 months |
| Change in QOL as measured by Symptom Checklist | Changes compared to baseline will be measured over a period of 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory Feld, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Cardiology Associates | Sacramento | California | 95819 | United States | ||
| UCSD Medical Center |
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| Medical management | Drug | Medical management- treatment with standard medical therapy, which includes anti-arrhythmic medications |
|
|
| 12 months |
| Change in QOL as measured by Arrhythmia Severity scale | Changes compared to baseline will be measured over a period of 12 months | 12 months |
| Change in luminal PV measurements | 6 months |
| Time to treatment failure, post resolution period | Time to treatment failure, defined as event monitor documented recurrent atrial fibrillation, post resolution period. | Post resolution period (12 months follow-up) |
| San Diego |
| California |
| 92103 |
| United States |
| UCSF Medical | San Francisco | California | 94143 | United States |
| University of Florida | Gainesville | Florida | 32611 | United States |
| University of South Florida | Tampa | Florida | 33606 | United States |
| Emory University | Atlanta | Georgia | 30308 | United States |
| University of Chicago Hospitals | Chicago | Illinois | 60637 | United States |
| Carle Heart Center | Urbana | Illinois | 61801 | United States |
| Genesis Health | Davenport | Iowa | 52803 | United States |
| Iowa Heart Center | Des Moines | Iowa | 50309 | United States |
| Cardiology Associates of Kentucky | Lexington | Kentucky | 40504 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| Englewood Hospital and Medical Center | Englewood | New Jersey | 07631 | United States |
| St. Luke's-Roosevelt Hospital Center | New York | New York | 10025 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| Penn State Heart and Vascular Institute | Hershey | Pennsylvania | 17033 | United States |
| Drexel University | Philadelphia | Pennsylvania | 19102 | United States |
| Austin Heart, PA | Austin | Texas | 78756 | United States |
| Methodist Debakey Heart Center | Houston | Texas | 77030 | United States |
| Tacoma General | Tacoma | Washington | 98415 | United States |
| Heart Care Associates | Milwaukee | Wisconsin | 53215 | United States |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011216 | Practice Management, Medical |
| ID | Term |
|---|---|
| D020399 | Practice Management |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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