Safety and Effectiveness of TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation
Public ClinicalTrials.gov record NCT03650556. 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 TactiCath™ Contact Force, Sensor Enabled™ (TactiCath SE) Catheter for Ablation of Drug Refractory, Symptomatic, Persistent Atrial Fibrillation (PERSIST-END IDE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This clinical investigation is intended to demonstrate the safety and effectiveness of the TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE) for use in cardiac electrophysiological mapping and for the treatment of drug-refractory, recurrent symptomatic persistent atrial fibrillation (AF) when used in conjunction with a compatible radiofrequency (RF) generator and three-dimensional mapping system. This clinical investigation will be conducted under an investigational device exemption (IDE) and is intended to support market approval of the TactiCath SE ablation catheter for the treatment of drug refractory, symptomatic persistent atrial fibrillation in the United States.
Study identification
- NCT ID
- NCT03650556
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 224 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Sep 28, 2018 (Actual)
- Primary completion
- Dec 21, 2020 (Actual)
- Completion
- Jan 11, 2021 (Actual)
- Last update posted
- Apr 27, 2022
2018 – 2021
United States locations
- U.S. sites
- 20
- U.S. states
- 17
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University Hospital (UAB) | Birmingham | Alabama | 35249 | — |
| St. Bernards | Jonesboro | Arkansas | 72401 | — |
| Arkansas Heart Hosptial | Little Rock | Arkansas | 72211 | — |
| Scripps Health | La Jolla | California | 92037 | — |
| Sequoia Hospital | Redwood City | California | 94062 | — |
| South Denver Cardiology Associates | Littleton | Colorado | 80120 | — |
| Florida Hospital | Orlando | Florida | 32803 | — |
| Emory University Hosptial | Atlanta | Georgia | 30322 | — |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | — |
| Johns Hopkins University Hospital | Baltimore | Maryland | 21287 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Jackson Heart Clinic | Jackson | Mississippi | 39216 | — |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | — |
| Bryan Heart | Lincoln | Nebraska | 68506 | — |
| Jersey Shore University Medical Center | Neptune City | New Jersey | 07753 | — |
| New York University Hospital | New York | New York | 10016 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Texas Cardiac Arrhythmia | Austin | Texas | 78705 | — |
| The Heart Hospital Baylor Plano | Plano | Texas | 75093 | — |
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 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03650556, 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 Apr 27, 2022 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03650556 live on ClinicalTrials.gov.