TactiFlex Paroxysmal Atrial Fibrillation IDE Trial
Public ClinicalTrials.gov record NCT04356040. 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
Safety and Effectiveness of the TactiFlex(TM) Ablation Catheter, Sensor Enabled(TM) (TactiFlex SE) for Treating Drug-refractory, Symptomatic Atrial Fibrillation.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Prospective non-randomized parallel-assignment multi-center clinical investigation. The study design includes two subject cohorts: 1) Paroxysmal Atrial Fibrillation Main Study, and 2) Paroxysmal Atrial Fibrillation High Standard Power Substudy. Subjects in the main study cohorts are to be treated using the full range of ablation power settings in the Instructions For Use. Subjects in the High Standard Power Substudy are to be treated in the upper end of the recommended ablation power settings (40-50 Watts).
Study identification
- NCT ID
- NCT04356040
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 355 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 99 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
- Jun 29, 2020 (Actual)
- Primary completion
- Jul 1, 2022 (Actual)
- Completion
- Jul 1, 2022 (Actual)
- Last update posted
- Oct 31, 2023
2020 – 2022
United States locations
- U.S. sites
- 30
- U.S. states
- 21
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Affinity Cardiovascular Specialists, LLC | Birmingham | Alabama | 35243 | — |
| St. Bernards Medical Center | Jonesboro | Arkansas | 72401 | — |
| Arkansas Heart Hospital | Little Rock | Arkansas | 72211 | — |
| Mills-Peninsula Medical Center | Burlingame | California | 94010 | — |
| Scripps Health | La Jolla | California | 92037 | — |
| University of California at San Diego (UCSD) Medical Center | San Diego | California | 92103 | — |
| South Denver Cardiology Associates PC | Littleton | Colorado | 80120 | — |
| AdventHealth Orlando | Orlando | Florida | 32806 | — |
| Piedmont Athens Regional Medical Center | Athens | Georgia | 30309 | — |
| St. Luke's Regional Medical Center | Boise | Idaho | 83712 | — |
| Kootenai Heart Clinics | Coeur d'Alene | Idaho | 83814 | — |
| St. Vincent Hospital | Indianapolis | Indiana | 46260 | — |
| Iowa Heart Center | West Des Moines | Iowa | 50266 | — |
| Kansas City Cardiac Arrhythmia Research Foundation | Overland Park | Kansas | 66211 | — |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Providence Hospital | Southfield | Michigan | 48075 | — |
| Jackson Heart Clinic | Jackson | Mississippi | 39216 | — |
| North Mississippi Medical Center | Tupelo | Mississippi | 38801 | — |
| New York University Hospital | New York | New York | 10016 | — |
| New York-Presbyterian/Columbia University Medical Center | New York | New York | 10032 | — |
| NC Heart & Vascular Research | Raleigh | North Carolina | 27607 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Ohio State University | Columbus | Ohio | 43210 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Texas Cardiac Arrhythmia Research Foundation | Austin | Texas | 78705 | — |
| Memorial Hermann Hospital | Houston | Texas | 77380 | — |
| The Heart Hospital Baylor Plano | Plano | Texas | 75204 | — |
| Franciscan Heart & Vascular Associates | Tacoma | Washington | 98405 | — |
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 15 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04356040, 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 31, 2023 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04356040 live on ClinicalTrials.gov.