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FIRM Ablation Versus Pulmonary Vein Isolation for the Treatment of Paroxysmal Atrial Fibrillation (PAF)

NCT02703454 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2019-05-21

Study results available
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Summary

The study is designed as a prospective, multicenter, single-blind, randomized study to assess the safety and effectiveness of FIRM-guided radiofrequency (RF) ablation procedures for the treatment of symptomatic paroxysmal atrial fibrillation (PAF). The subjects will be blinded to study treatment for the duration of the study period.

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

PROCEDURE

FIRM-guided RF ablation

PROCEDURE

Conventional RF ablation

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Roland R. Tilz, PD Dr. med. · Universität zu Lübeck

  • Phillipp Sommer, PD Dr. med. · University of Leipzig

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2018-02-28
Completion
2018-02-28

Countries

  • Germany

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 NCT02703454 on ClinicalTrials.gov