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NCT03624881 · ClinicalTrials.gov registry record · Phase 4
Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU)
A Phase 4 study of Paroxysmal Atrial Fibrillation, sponsored by Biosense Webster.
- Completed
- Registry status
- Phase 4
- Development phase
- 333
- Enrollment target
- 20
- Study locations
NCT03624881 is a Phase 4 study of Paroxysmal Atrial Fibrillation that has completed, run by Biosense Webster. The registered enrollment target is 333 participants, below the 845-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (61% lower). The trial reports 20 study locations across 9 states.
The verdict
NCT03624881, a Phase 4 study of Paroxysmal Atrial Fibrillation, has completed, sponsored by Biosense Webster.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 333 participants
- Enrollment target
- 20
- Study locations
Study Summary
Prospective, non-randomized, post market clinical evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with STSF catheter and ST catheter compared to an historical control performance goal. A maximum of 330 subjects will be enrolled across up to 45 sites. Two hundred eighty (280) enrolled subjects will be treated using the STSF catheter with EPU and 50 subjects will be treated using the ST catheter with EPU. Prior to enrollment, a few sites will be selected to only enroll subjects who will be treated with the ST catheter and the remaining sites will only enroll subjects who will be treated with the STSF catheter. Bayesian adaptive design will be used to assess early success at up to two interims: one after all subjects have completed the 3- month follow-up assessment, and a second to occur after all subjects have completed the 6 months follow-up visit.
Conditions Studied
Interventions
- DEVICE Catheter ablation with EPU
Study Locations (20)
Florida
- JFK Medical Center - Atlantis
- Memorial Healthcare - Hollywood
- Florida Hospital - Orlando
- Baptist Hospital/Cardiology Consultants - Pensacola
- Tampa General Hospital - Tampa
California
- Scripps Health - San Diego
- San Diego Cardiac Center - San Diego
- Marian Regional Medical Center - Santa Maria
- St. John's Providence - Santa Monica
Alabama
- University of Alabama at Birmingham - Birmingham
- Grandview Medical Center - Birmingham
- Huntsville Hospital - Huntsville
Illinois
- Evanston Community - Evanston
- Loyola University Medical Center - Maywood
- Prairie Heart Institute - Springfield
Arkansas
- CHI St. Vincent - Little Rock
Colorado
- University of Colorado Denver - Denver
Georgia
- Emory St. Joseph's - Atlanta
Kentucky
- Baptist Health Lexington - Kensington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 333 participants |
| Start Date | 2018-09-04 |
| Est. Completion | 2021-06-28 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03624881
The ClinicalTrials.gov registry entry for NCT03624881 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 333 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 845-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (61% lower). The listed sponsor is Biosense Webster, which has 18 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Paroxysmal Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which Catheter ablation with EPU is the first listed.
NCT03624881 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT03624881 about?
NCT03624881 is a clinical study titled "Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU)". Prospective, non-randomized, post market clinical evaluation of the VISITAG SURPOINT™ Module with External Processing Unit (EPU) when used with STSF catheter and ST catheter compared to an historical control performance goal. A maximum of 330 subjects will be enrolled across up to 45 sites. Two hun...
What is the current status of trial NCT03624881?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 333 participants. The study started on 2018-09-04. Estimated completion is 2021-06-28.
What conditions does trial NCT03624881 study?
This clinical trial studies the following conditions: Paroxysmal Atrial Fibrillation.
What interventions are being tested in trial NCT03624881?
The interventions under investigation include: Catheter ablation with EPU (DEVICE).
Who is sponsoring clinical trial NCT03624881?
This trial is sponsored by Biosense Webster, which has 18 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03624881 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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Read our methodology - how this data is sourced, computed, and verified.
Related
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