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Randomized Evaluation of Redo Ablation Procedures of Atrial Fibrillation With FIRM Guided Procedures

NCT02799043 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 269

Last updated 2024-09-19

Study results available
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Summary

A prospective, multicenter, randomized study to assess the safety and effectiveness of FIRM-guided procedures in conventional "redo" RF ablation procedures for the treatment of persistent and paroxysmal atrial fibrillation.

Conditions

  • Persistent Atrial Fibrillation
  • Paroxysmal Atrial Fibrillation

Interventions

PROCEDURE

Standard PVI

Standard PVI procedure without FIRMap.

PROCEDURE

FIRM-Guided Procedure and PVI

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Vivek Reddy, MD · MOUNT SINAI HOSPITAL

  • Stefan G. Spitzer, MD · Praxisklinik Herz und Gefäße Dresden, Germany

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • United States
  • Belgium
  • Germany
  • Netherlands

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 NCT02799043 on ClinicalTrials.gov