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COMPLETED Phase 4

Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU)

NCT03624881 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 333 participants
Start Date 2018-09-04
Est. Completion 2021-06-28
Phase Phase 4

Sponsor

Biosense Webster

6 total trials

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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. It is categorized as Phase 4, 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 333 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biosense Webster, which has 6 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 1 intervention — of which Catheter ablation with EPU 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: NCT03624881 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, California, Alabama. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03624881?

The interventions under investigation include: Catheter ablation with EPU (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03624881?

This trial is sponsored by Biosense Webster, which has 6 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial