MedTrace Logo

Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.

NCT03437733 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2025-06-29

Study results available
· View outcomes & findings →

Summary

This clinical investigation is a prospective, multicenter, single arm clinical evaluation utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode circular diagnostic catheter.

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

DEVICE

Radiofrequency Ablation

RF ablation using multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter

Sponsors & Collaborators

  • Biosense Webster, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2018-02-28
Primary Completion
2019-02-01
Completion
2019-10-17
FDA Device
Yes

Countries

  • Czechia
  • Italy
  • United Kingdom

Study Locations

More Related Trials

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 NCT03437733 on ClinicalTrials.gov