A Clinical Study of the Arctic Front Cryoablation Balloon for the Treatment of Paroxysmal Atrial Fibrillation
Public ClinicalTrials.gov record NCT00523978. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized, Controlled Clinical Trial of Catheter Cryoablation in the Treatment of Paroxysmal Atrial Fibrillation.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study (STOP AF) is a prospective, randomized, controlled, multicenter, pivotal clinical investigation conducted at 26 investigational sites in the United States and Canada. Subjects with paroxysmal atrial fibrillation (PAF) referred for ablative intervention after efficacy failure of one or more Study Atrial Fibrillation (AF) Drugs (flecainide, propafenone or sotalol) were randomized 2:1 to cryoablation intervention (Experimental Subjects, ES) or to a Study AF Drug (Control Subjects, CS). Subjects were followed for 12 months with scheduled and symptom-driven assessments to detect recurrent atrial fibrillation by means of periodic electrocardiograms, weekly scheduled trans-telephonic monitoring, patient-initiated trans-telephonic monitoring, and 24-hour Holter monitoring at 6 and 12 months. The first 90 days after study therapy was initiated was considered a blanked period for all subjects.
Study identification
- NCT ID
- NCT00523978
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 245 participants
Conditions and interventions
Conditions
Interventions
Device · Drug
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 2006 (Type not available)
- Primary completion
- Aug 2010 (Actual)
- Completion
- Jul 2011 (Actual)
- Last update posted
- Oct 16, 2018
2006 – 2011
United States locations
- U.S. sites
- 23
- U.S. states
- 16
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294-0007 | — |
| Banner Good Samaritan Medical Center | Phoenix | Arizona | 85006 | — |
| Cedar Sinai Medical Center | Los Angeles | California | 90048 | — |
| UC Davis Medical Center | Sacramento | California | 98517 | — |
| Stanford Hospital | Stanford | California | 94305-5233 | — |
| Colorado Cardiac Alliance -- Memorial Hospital | Colorado Springs | Colorado | 80907 | — |
| Mayo Clinic- Jacksonville | Jacksonville | Florida | 32224 | — |
| BayHeart Group -- St-Joseph's Hospital | Tampa | Florida | 33607 | — |
| Emery Crawford Long Hospital | Atlanta | Georgia | 30308 | — |
| Piedmont Hospital | Atlanta | Georgia | 30309 | — |
| Iowa Heart Center | Des Moines | Iowa | 50314 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Mayo Clinic | Rochester | Minnesota | 55902 | — |
| New Mexico Heart Institute | Albuquerque | New Mexico | 87102 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| University of Pennsylvania Health | Philadelphia | Pennsylvania | 19104-4283 | — |
| Baylor Heart and Vascular Hospital | Dallas | Texas | 75226 | — |
| Inova Research Center | Falls Church | Virginia | 22042 | — |
| Sentara CV Research Institute | Norfolk | Virginia | 23507 | — |
| Medical College of Virginia | Richmond | Virginia | 23219 | — |
| Cardiology Associates of Green Bay | Green Bay | Wisconsin | 54301-3596 | — |
| Arrhythmia Center of Southern WI | Milwaukee | Wisconsin | 53215 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00523978, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 16, 2018 · Synced Oct 26, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00523978 live on ClinicalTrials.gov.