Vimecon CAI Trial for the Interventional Treatment of Paroxysmal Atrial Fibrillation (AF)

NCT02770989 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2018-12-13

No results posted yet for this study

Summary

This study is a prospective, non-randomized, single arm, multicenter, CE marking trial for patients with paroxysmal atrial fibrillation to undergo an ablation of the cardiac tissue near the PV.

Conditions

Interventions

PROCEDURE

Vimecon Laser CAI percutaneous cardiac ablation

The Vimecon Laser CAI catheter is entered through the femoral vein to access the pulmonary vein (PV) area in the heart in order to ablate the cardiac wall near the PV to create scar tissue and to isolate the PV in order to treat atrial fibrillation.

Sponsors & Collaborators

  • Vimecon GmbH

    lead INDUSTRY

Principal Investigators

  • René Spaargaren, Dr. · Director Clinical Affairs

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-03-31
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • Belgium
  • Czechia
  • Germany

Study Locations

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Entities

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 NCT02770989 on ClinicalTrials.gov