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CardioFocus vs. Contact Force Guided Pulmonary Vein Isolation in Paroxysmal Atrial Fibrillation

NCT03056222 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2021-11-19

No results posted yet for this study

Summary

The aim of the study is to compare the acute procedure and safety outcomes as well as long term clinical outcomes of 2 groups of patients treated with the HeartLight® Endoscopically Guided Laser Ablation (EGLA) or a commercially available Contact Force Sensing Irrigated Radiofrequency (RF) Ablation Catheter plus, at the operator's discretion, 3D Electroanatomical Mapping (EAM) for the treatment of Paroxysmal Atrial Fibrillation (PAF).

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DEVICE

Ablation catheter

Ablation of paroxysmal atrial fibrillation

Sponsors & Collaborators

  • I-Med-Pro GmbH

    lead OTHER

Principal Investigators

  • Andreas Metzner, PD Dr. med. · Universitäres Herz- und Gefäßzentrum UKE Hamburg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-04-10
Primary Completion
2021-08-16
Completion
2021-11-15
FDA Device
Yes

Countries

  • Belgium
  • Czechia
  • Germany
  • United Kingdom

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 NCT03056222 on ClinicalTrials.gov