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Medtronic Terminate AF Study

NCT03546374 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-05-14

No results posted yet for this study

Summary

The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal atrial fibrillation (AF).

Conditions

  • Persistent Atrial Fibrillation
  • Longstanding Persistent Atrial Fibrillation

Interventions

PROCEDURE

Surgical Ablation

In addition to the concomitant surgery, subjects are required to have amputation or closure (with sutures or ligation) of the left atrial appendage.The Cox Maze IV lesion set is required to be performed.

DEVICE

Cardioblate and Cryoflex hand held devices

The Cardioblate hand held devices consist of the Cardioblate iRF and Cryoflex surgical ablation devices.

Sponsors & Collaborators

  • Medtronic Cardiac Surgery

    lead INDUSTRY

Principal Investigators

  • Ralph J Damiano, MD · Washington University School of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-15
Primary Completion
2024-10-01
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03546374 on ClinicalTrials.gov