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

NCT03437733 | Completed Results DMC FDA Device

• 1 other identifier: BWI_2017_01
• Study Type: interventional
• Target: 98
• Locations: 3 countries
• Sites: 5

Brief 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

Keywords

Radiofrequency Ablation; Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Early Onset Primary Adverse Events (PAEs): Death, Atrio-esophageal Fistula and Pulmonary Vein Stenosis

  A Primary AEs is an event which occurred within 90 days following initial ablation procedure. Primary AEs included: Death, atrio-esophageal fistula, and pulmonary vein stenosis.

  Up to 90 days (post initial mapping and ablation procedure)

• Number of Participants With Early Onset PAEs: Myocardial Infraction, Cardiac Tamponade/Perforation, Thromboembolism, Stroke/Cerebrovascular Accident, Transient Ischemic Attack, Phrenic Nerve Paralysis, and Major Vascular Access Complication/Bleeding

  A Primary AEs is an event which occurred within the first week (7 days of the initial mapping and ablation procedure) which included myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cerebrovascular accident (CVA), Transient ischemic attack (TIA), phrenic nerve paralysis (PNP), and major vascular access complication (MVAC)/bleeding following initial ablation procedure.

  Up to 7 days (post initial mapping and ablation procedure)

• Percentage of Participants With Acute Procedural Success

  Acute procedural success is defined as confirmation of entrance block in treated pulmonary veins (PV) after adenosine and/or isoproterenol challenge (with or without the use of a focal catheter).

  Day 1

Secondary Outcomes (14)

• Number of Participants With Individual PAE From Primary Composite

  Up to 7 days for MI, CT/perforation, thromboembolism, stroke/CVA, TIA, PNP and MVAC (initial mapping and ablation procedure) and up to 90 days for death, AE fistula, and PVST (post procedure)

• Number of Participants With Serious Adverse Device Effects (SADEs)

  Up to 405 Days

• Number of Participants With Serious Non-primary Adverse Events Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (>=) 31 Days (Late Onset) of Initial Ablation Procedure

  Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days)

• Number of Participants With Non-serious Adverse Events

  Up to 405 Days

• Number of Participants With Pre-and Post-ablation Asymptomatic and Symptomatic Cerebral Emboli

  Pre-procedure, at Discharge, 1 Month and at unscheduled visit (Up to 405 Days)

Study Arms (1)

Intervention

EXPERIMENTAL

Ablation with Multi-electrode Radiofrequency (RF) Balloon Catheter

Device: Radiofrequency Ablation

Interventions

Radiofrequency Ablation DEVICE

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

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
• Previous surgical or catheter ablation for AF.
• Anticipated to receive ablation outside the PV ostia and Cavo-triscuspid-isthmus (CTI) region
• Previously diagnosed with persistent, longstanding AF and/or continuous AF \> 7 days, or \> 48 hrs terminated by cardioversion.
• Any percutaneous coronary intervention (PCI) within the past 2 months.
• Valve repair or replacement and presence of a prosthetic valve.
• Any carotid stenting or endarterectomy.
• Coronary artery bypass grafting (CABG), cardiac surgery (e.g. ventriculotomy, atriotomy), or valvular cardiac surgical or percutaneous procedure within the past 6 months.
• Documented left atrium (LA) thrombus on baseline/pre-procedure imaging.
• LA antero posterior diameter \> 50 mm
• Any PV with a diameter ≥ 26 mm
• Left Ventricular Ejection Fraction (LVEF) \< 40%.
• Contraindication to anticoagulation (e.g. heparin).
• History of blood clotting or bleeding abnormalities.
• Myocardial infarction within the past 2 months.

Sponsors & Collaborators

• Biosense Webster, Inc.: lead

Study Sites (5)

Na Homolce Hospital

Prague, Czechia

Location

Ospedale "F. Miulli"

Bari, Italy

Location

Centro Cardiologico Monzino

Milan, Italy

Location

Liverpool Heart and Chest Hospital

Liverpool, United Kingdom

Location

Bart's Health NHS Trust

London, United Kingdom

Location

Related Publications (1)

• Schilling R, Dhillon GS, Tondo C, Riva S, Grimaldi M, Quadrini F, Neuzil P, Chierchia GB, de Asmundis C, Abdelaal A, Vanderlinden L, Tan T, Ding WY, Gupta D, Reddy VY. Safety, effectiveness, and quality of life following pulmonary vein isolation with a multi-electrode radiofrequency balloon catheter in paroxysmal atrial fibrillation: 1-year outcomes from SHINE. Europace. 2021 Jun 7;23(6):851-860. doi: 10.1093/europace/euaa382.

  PMID: 33450010 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Franchise Medical Director
• Organization: Biosense Webster, Inc.

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: February 19, 2018
• Study Start: February 28, 2018
• Primary Completion: February 1, 2019
• Study Completion: October 17, 2019
• Last Updated: June 29, 2025
• Results First Posted: February 10, 2020

Record last verified: 2025-06

Locations

IT (2); GB (2); CZ (1)