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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: Completed Phase 4 study of Paroxysmal Atrial Fibrillation, sponsored by Biosense Webster.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A PAE is a serious adverse event (SAEs), which occurred within the first week (7 days) following an atrial fibrillation (AF) ablation procedure with use of Tag Index. Pulmonary vein (PV) stenosis and atrio-esophageal fistula that occurred greater than one week (7 days) post-procedure were deemed Primary AEs. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening exp
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 |
What the finished NCT03624881 record still lists
NCT03624881 is an interventional study that assigns participants to a tested intervention. The registered 333 participants enrollment target is mid-sized for trials with a published cap, below the 845-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (61% lower).
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 names 20 study sites across 9 states, led by 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.
Learn More About Clinical Trials
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Where NCT03624881's enrollment target sits among peer trials
333 6th of 24 higher than 19 of 24 other Paroxysmal Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Paroxysmal Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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