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Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation

NCT04190186 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-07-29

Study results available
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Summary

This clinical trial is designed to compare two management strategies for the treatment of asymptomatic/subclinical atrial fibrillation after ablation based on data from the Biotronik ICM (BioMonitor3® or future generation of Biotronik ICM).

Conditions

  • Persistent Atrial Fibrillation

Interventions

DEVICE

Insertable Cardiac Monitor

Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.

Sponsors & Collaborators

  • Biotronik, Inc.

    collaborator INDUSTRY

  • University of Rochester

    lead OTHER

Principal Investigators

  • David Huang, MD · University of Rochester

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-25
Primary Completion
2024-02-15
Completion
2024-02-15
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 NCT04190186 on ClinicalTrials.gov