Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF
Public ClinicalTrials.gov record NCT04198701. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The study is a prospective, multi-center, non-randomized, unblinded worldwide pre-market clinical study. The purpose of the study is to provide data demonstrating the safety and effectiveness of the PulseSelect™ PFA System for the treatment of atrial fibrillation (AF). The study will also provide first in human insights into clinical safety and device function of the PulseSelect PFA System for pulmonary vein isolation (PVI) as a treatment for AF. To this end, the clinical study has been designed into phases (Pilot and Pivotal), with each phase comprising a separate data set that will be analyzed and reported on per the below objectives.
Study identification
- NCT ID
- NCT04198701
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 421 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- 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
- Dec 10, 2019 (Actual)
- Primary completion
- Nov 28, 2022 (Actual)
- Completion
- Nov 28, 2022 (Actual)
- Last update posted
- Feb 13, 2025
2019 – 2022
United States locations
- U.S. sites
- 27
- U.S. states
- 21
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Grandview Medical Center | Birmingham | Alabama | 35243 | — |
| Medical Center of the Rockies | Loveland | Colorado | 80538 | — |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| BayCare Saint Joseph's Hospital | Tampa | Florida | 33607 | — |
| Emory Saint Joseph's Hospital | Atlanta | Georgia | 30322 | — |
| Northwestern University Hospital | Chicago | Illinois | 60611 | — |
| Iowa Heart Center | Des Moines | Iowa | 50314 | — |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | — |
| Southcoast Health System | Fall River | Massachusetts | 02720 | — |
| Spectrum Health | Grand Rapids | Michigan | 49503 | — |
| Beaumont Hospital | Royal Oak | Michigan | 48073 | — |
| Mayo Clinic (Rochester MN) | Rochester | Minnesota | 55902 | — |
| Saint Luke's Mid America Heart Institute | Kansas City | Missouri | 64111 | — |
| The Valley Hospital | Ridgewood | New Jersey | 07450 | — |
| Northwell Health - North Shore University Hospital | Manhasset | New York | 11030 | — |
| NYU Langone Health - Heart Rhythm Center | New York | New York | 10016 | — |
| Montefiore Medical Center | The Bronx | New York | 10467 | — |
| Mission Hospital | Asheville | North Carolina | 28803 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | — |
| Providence Saint Vincent Medical Center | Portland | Oregon | 97225 | — |
| Doylestown Hospital | Doylestown | Pennsylvania | 18901 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| University of Pittsburgh Medical Center- UPMC Presbyterian | Pittsburgh | Pennsylvania | 15213 | — |
| St. David's Medical Center | Austin | Texas | 78705 | — |
| University of Virginia Medical Center | Charlottesville | Virginia | 22908 | — |
| Swedish Medical Center Cherry Hill | Seattle | Washington | 98122 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 14 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04198701, 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 Feb 13, 2025 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04198701 live on ClinicalTrials.gov.