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TactiFlex Paroxysmal Atrial Fibrillation IDE Trial
NCT04356040 · View on ClinicalTrials.gov ↗
Study Summary
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).
Conditions Studied
Interventions
- DEVICE TactiFlex SE
- DEVICE TactiFlex SE - High Standard Power
Study Locations (20)
California
- Mills-Peninsula Medical Center — Burlingame
- Scripps Health — La Jolla
- University of California at San Diego (UCSD) Medical Center — San Diego
Arkansas
- St. Bernards Medical Center — Jonesboro
- Arkansas Heart Hospital — Little Rock
Idaho
- St. Luke's Regional Medical Center — Boise
- Kootenai Heart Clinics — Coeur d'Alene
Mississippi
- Jackson Heart Clinic — Jackson
- North Mississippi Medical Center — Tupelo
Alabama
- Affinity Cardiovascular Specialists, LLC — Birmingham
Colorado
- South Denver Cardiology Associates PC — Littleton
Florida
- AdventHealth Orlando — Orlando
Georgia
- Piedmont Athens Regional Medical Center — Athens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 355 participants |
| Start Date | 2020-06-29 |
| Est. Completion | 2022-07-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04356040
The ClinicalTrials.gov registry entry for NCT04356040 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 355 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 155 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Paroxysmal Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions — of which TactiFlex SE is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04356040 reports 20 study locations spanning 15 distinct geographic areas — top geographies include California, Arkansas, Idaho. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04356040 about?
NCT04356040 is a clinical study titled "TactiFlex Paroxysmal Atrial Fibrillation IDE Trial". 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 us...
What is the current status of trial NCT04356040?
This trial is currently completed. It is a NA study. The enrollment target is 355 participants. The study started on 2020-06-29. Estimated completion is 2022-07-01.
What conditions does trial NCT04356040 study?
This clinical trial studies the following conditions: Paroxysmal Atrial Fibrillation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04356040?
The interventions under investigation include: TactiFlex SE (DEVICE), TactiFlex SE - High Standard Power (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04356040?
This trial is sponsored by Abbott Medical Devices, which has 155 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04356040 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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