MedTrace Logo

Radiofrequency vs Cryoballoon Ablation for Atrial Fibrillation Assessed by Implantable Cardiac Monitor

NCT03805555 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2021-09-08

No results posted yet for this study

Summary

The study is a prospective randomized comparison of two methods of catheter ablation of atrial fibrillation: Radiofrequency ablation which is the standard of care will be compared to Cryoballoon ablation to perform pulmonary vein isolation. Primary endpoint for the randomized comparison is the number of pulmonary veins that remain isolated on follow up investigation. All patients will receive an implantable loop recorder to monitor clinical response and identify patients who benefit the most from durable pulmonary vein isolation. All patients will undergo a follow-up invasive assessment of pulmonary vein isolation, and veins with reconnection will be re-isolated to determine if this strategy alters clinical long-term outcome of ablation.

Conditions

Interventions

PROCEDURE

Radiofrequency ablation

Pulmonary vein isolation by radiofrequency ablation

PROCEDURE

Cryoballoon ablation

Pulmonary vein isolation by cryoballoon ablation

Sponsors & Collaborators

  • University Hospital, Gentofte, Copenhagen

    lead OTHER

Principal Investigators

  • Jim Hansen, MD · UH Gentofte

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2019-02-28
Completion
2020-10-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Diseases

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 NCT03805555 on ClinicalTrials.gov