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NCT04198701 · ClinicalTrials.gov registry record · NA

Pulsed Field Ablation to Irreversibly Electroporate Tissue and Treat AF

A NA study of Atrial Fibrillation, sponsored by Medtronic Cardiac Ablation Solutions.

Completed
Registry status
NA
Development phase
421
Enrollment target
20
Study locations

NCT04198701 is a NA study of Atrial Fibrillation that has completed, run by Medtronic Cardiac Ablation Solutions. The registered enrollment target is 421 participants, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 16 states.

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The verdict

NCT04198701, a NA study of Atrial Fibrillation, has completed, sponsored by Medtronic Cardiac Ablation Solutions.

COMPLETED
Registry status
NA
Development phase
421 participants
Enrollment target
20
Study locations

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

Atrial Fibrillation

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

Sponsor

Medtronic Cardiac Ablation Solutions

20 total trials

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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, categorized as NA. The registered enrollment target is 421 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (86% lower). The listed sponsor is Medtronic Cardiac Ablation Solutions, which has 20 total studies on file at ClinicalTrials.gov.

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.

NCT04198701 reports 20 study locations spanning 16 distinct geographic areas - top geographies include New York, Michigan, Ohio.

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.

What interventions are being tested in trial NCT04198701?

The interventions under investigation include: Medtronic PulseSelect Pulsed Field Ablation (PFA) System (DEVICE).

Who is sponsoring clinical trial NCT04198701?

This trial is sponsored by Medtronic Cardiac Ablation Solutions, which has 20 total clinical trials registered on ClinicalTrials.gov.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.