Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED NA

Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF

NCT04198701 · View on ClinicalTrials.gov ↗

Study Summary

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.

Conditions Studied

Interventions

  • DEVICE Medtronic PulseSelect Pulsed Field Ablation (PFA) System

Study Locations (20)

New York

  • Northwell Health - North Shore University Hospital — Manhasset
  • NYU Langone Health - Heart Rhythm Center — New York
  • Montefiore Medical Center — The Bronx

Michigan

  • Spectrum Health — Grand Rapids
  • Beaumont Hospital — Royal Oak

Ohio

  • Cleveland Clinic — Cleveland
  • The Ohio State University Wexner Medical Center — Columbus

Alabama

  • Grandview Medical Center — Birmingham

Colorado

  • Medical Center of the Rockies — Loveland

District of Columbia

  • MedStar Washington Hospital Center — Washington D.C.

Florida

  • BayCare Saint Joseph's Hospital — Tampa

Georgia

  • Emory Saint Joseph's Hospital — Atlanta

Trial Details

FieldValue
Enrollment Target 421 participants
Start Date 2019-12-10
Est. Completion 2022-11-28
Phase NA

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04198701

The ClinicalTrials.gov registry entry for NCT04198701 describes a study currently listed as completed. It is categorized as NA, 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 421 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medtronic Cardiac Ablation Solutions, which has 12 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 Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention — of which Medtronic PulseSelect Pulsed Field Ablation (PFA) System 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: NCT04198701 reports 20 study locations spanning 16 distinct geographic areas — top geographies include New York, Michigan, Ohio. 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 NCT04198701 about?

NCT04198701 is a clinical study titled "Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF". 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 fi...

What is the current status of trial NCT04198701?

This trial is currently completed. It is a NA study. The enrollment target is 421 participants. The study started on 2019-12-10. Estimated completion is 2022-11-28.

What conditions does trial NCT04198701 study?

This clinical trial studies the following conditions: 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 NCT04198701?

The interventions under investigation include: Medtronic PulseSelect Pulsed Field Ablation (PFA) System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04198701?

This trial is sponsored by Medtronic Cardiac Ablation Solutions, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04198701 being conducted?

This trial has 20 study locations across Alabama, Colorado, District of Columbia, Florida, Georgia. 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