Evaluation of VISITAG SURPOINT™ Module With External Processing Unit (EPU)
Public ClinicalTrials.gov record NCT03624881. 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
Evaluation of the VISITAG SURPOINT™ Module With External Processing Unit (EPU) When Used With the THERMOCOOL SMARTTOUCH® SF and the THERMOCOOL SMARTTOUCH® Catheters for Pulmonary Vein Isolation (PVI) (SURPOINT COA)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03624881
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 333 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 3, 2018
- Primary completion
- Jun 27, 2021
- Completion
- Jun 27, 2021
- Last update posted
- Jul 2, 2023
2018 – 2021
United States locations
- U.S. sites
- 41
- U.S. states
- 24
- U.S. cities
- 37
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Grandview Medical Center | Birmingham | Alabama | 35243 | — |
| Huntsville Hospital | Huntsville | Alabama | 35801 | — |
| CHI St. Vincent | Little Rock | Arkansas | 72205 | — |
| Scripps Health | San Diego | California | 92037 | — |
| San Diego Cardiac Center | San Diego | California | 92123 | — |
| Marian Regional Medical Center | Santa Maria | California | 93454 | — |
| St. John's Providence | Santa Monica | California | 90404 | — |
| University of Colorado Denver | Denver | Colorado | 80204 | — |
| JFK Medical Center | Atlantis | Florida | 33462 | — |
| Memorial Healthcare | Hollywood | Florida | 33021 | — |
| Florida Hospital | Orlando | Florida | 92803 | — |
| Baptist Hospital/Cardiology Consultants | Pensacola | Florida | 32501 | — |
| Tampa General Hospital | Tampa | Florida | 33606 | — |
| Emory St. Joseph's | Atlanta | Georgia | 30342 | — |
| Evanston Community | Evanston | Illinois | 60201 | — |
| Loyola University Medical Center | Maywood | Illinois | 60153 | — |
| Prairie Heart Institute | Springfield | Illinois | 62769 | — |
| Baptist Health Lexington | Kensington | Kentucky | 40503 | — |
| Oschner LSU Health Shreveport | Shreveport | Louisiana | 71103 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Abbott Northwestern | Minneapolis | Minnesota | 55407 | — |
| Lovelace Medical Center | Albuquerque | New Mexico | 87102 | — |
| Albany Medical Center | Albany | New York | 12208 | — |
| NYU Langone | New York | New York | 10016 | — |
| New York Presbyterian | New York | New York | 10065 | — |
| Albert Einstein College of Medicine | New York | New York | 10467 | — |
| Duke University Medical Center | Durham | North Carolina | 27705 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| Ohio State University Medical Center | Columbus | Ohio | 43210 | — |
| Oklahoma Heart Institute | Oklahoma City | Oklahoma | 73104 | — |
| Providence St Vincent Medical Center | Portland | Oregon | 97225 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| Greenville Health System | Greenville | South Carolina | 29605 | — |
| Erlanger Health System | Chattanooga | Tennessee | 37403 | — |
| Texas Health Heart and Vascular Hospital | Arlington | Texas | 76012 | — |
| St. David's Medical Center | Austin | Texas | 78705 | — |
| Intermountain Medical | Murray | Utah | 84107 | — |
| Sentara Health | Norfolk | Virginia | 23507 | — |
| MultiCare Tacoma | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03624881, 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 Jul 2, 2023 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03624881 live on ClinicalTrials.gov.