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Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins. | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT03437733•Biosense Webster, Inc.

View on ClinicalTrials.gov

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.

Detailed Description

The objective of this clinical investigation is to assess the safety and acute effectiveness of the multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter when used for the isolation of the pulmonary veins in the treatment of Paroxysmal Atrial Fibrillation (PAF).

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Diagnosed with Symptomatic Paroxysmal AF.
•2. Selected for atrial fibrillation (AF) ablation procedure for pulmonary vein isolation.
•3. Able and willing to comply with uninterrupted per-protocol anticoagulation requirements
•4. Age 18-75 years.
•5. Able and willing to comply with all pre-, post- and follow-up testing and requirements.
•6. Signed Patient Informed Consent Form.

Exclusion Criteria

•1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
•2. Previous surgical or catheter ablation for AF.
•3. Anticipated to receive ablation outside the PV ostia and Cavo-triscuspid-isthmus (CTI) region
•4. Previously diagnosed with persistent, longstanding AF and/or continuous AF \> 7 days, or \> 48 hrs terminated by cardioversion.
•5. Any percutaneous coronary intervention (PCI) within the past 2 months.
•6. Valve repair or replacement and presence of a prosthetic valve.
•7. Any carotid stenting or endarterectomy.
•8. Coronary artery bypass grafting (CABG), cardiac surgery (e.g. ventriculotomy, atriotomy), or valvular cardiac surgical or percutaneous procedure within the past 6 months.
•9. Documented left atrium (LA) thrombus on baseline/pre-procedure imaging.
•10. LA antero posterior diameter \> 50 mm
+27 more criteria

Locations (5)

Na Homolce Hospital

Prague, Czechia

Ospedale "F. Miulli"

Bari, Italy

Centro Cardiologico Monzino

Milan, Italy

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom

Bart's Health NHS Trust

London, United Kingdom

Key Dates

Start Date

February 28, 2018

Primary Completion Date

February 1, 2019

Completion Date

October 17, 2019

Last Updated

June 29, 2025

Enrollment

ACTUAL participants

Conditions

Paroxysmal Atrial Fibrillation

Interventions

Radiofrequency Ablation

DEVICE

Burst Stimulation for Paroxysmal Atrial Fibrillation

NCT07281898

Paroxysmal Atrial Fibrillation

View study

RECRUITINGPHASE4

Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias

NCT06765356

Persistent Atrial FibrillationParoxysmal Atrial Fibrillation+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Burst Stimulation for Paroxysmal Atrial Fibrillation

Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias

VOLT CE Mark Study

Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF)

ADVENT Post Approval Study

Safety and Effectiveness of the Globe® Pulsed Field System for Treating Patients With Symptomatic Paroxysmal or Persistent Atrial Fibrillation