---
title: Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.
nct_id: NCT03437733
overall_status: COMPLETED
phase: NA
sponsor: Biosense Webster, Inc.
study_type: INTERVENTIONAL
primary_condition: Paroxysmal Atrial Fibrillation
countries: Czechia, Italy, United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03437733.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03437733"
ct_last_update_post_date: 2025-06-29
last_seen_at: "2026-05-12T06:42:25.386Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.

**NCT ID:** [NCT03437733](https://clinicaltrials.gov/study/NCT03437733)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 98
- **Lead Sponsor:** Biosense Webster, Inc.
- **Conditions:** Paroxysmal Atrial Fibrillation
- **Start Date:** 2018-02-28
- **Completion Date:** 2019-10-17
- **CT.gov Last Update:** 2025-06-29

## 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.

## 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

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
11. Any PV with a diameter ≥ 26 mm
12. Left Ventricular Ejection Fraction (LVEF) \< 40%.
13. Contraindication to anticoagulation (e.g. heparin).
14. History of blood clotting or bleeding abnormalities.
15. Myocardial infarction within the past 2 months.
16. Documented thromboembolic event \[including transient ischemic attack(TIA)\] within the past 12 months.
17. Rheumatic Heart Disease.
18. Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.
19. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.
20. Unstable angina.
21. Acute illness or active systemic infection or sepsis.
22. Diagnosed atrial myxoma or interatrial baffle or patch.
23. Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).
24. Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.
25. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study.
26. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.
27. Enrollment in an investigational study evaluating another device, biologic, or drug.
28. Has known pulmonary vein stenosis.
29. Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter.
30. Presence of an Inferior Vena Cava (IVC) filter
31. Presence of a condition that precludes vascular access.
32. Life expectancy or other disease processes likely to limit survival to less than 12 months.
33. Presenting contra-indication for the devices (e.g. transthoracic echocardiography (TTE), CT, etc.) used in the study, as indicated in the respective instructions for use.
34. Categorized as a vulnerable population and requires special treatment with respect to safeguards of well-being

    Additional exclusion criteria for Neurological Assessment Evaluable (NAE) subjects:
35. Contraindication to use of contrast agents for MRI such as advanced renal disease, etc. (at PI discretion)
36. Presence of iron-containing metal fragments in the body
37. Unresolved pre-existing neurological deficit.
```

## Arms

- **Intervention** (EXPERIMENTAL) — Ablation with Multi-electrode Radiofrequency (RF) Balloon Catheter

## Interventions

- **Radiofrequency Ablation** (DEVICE) — RF ablation using multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter

## Primary Outcomes

- **Number of Participants With Early Onset Primary Adverse Events (PAEs): Death, Atrio-esophageal Fistula and Pulmonary Vein Stenosis** _(time frame: Up to 90 days (post initial mapping and ablation procedure))_ — 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.
- **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** _(time frame: Up to 7 days (post initial mapping and ablation procedure))_ — 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.
- **Percentage of Participants With Acute Procedural Success** _(time frame: Day 1)_ — 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).

## Secondary Outcomes

- **Number of Participants With Individual PAE From Primary Composite** _(time frame: 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)** _(time frame: 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** _(time frame: 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** _(time frame: Up to 405 Days)_
- **Number of Participants With Pre-and Post-ablation Asymptomatic and Symptomatic Cerebral Emboli** _(time frame: Pre-procedure, at Discharge, 1 Month and at unscheduled visit (Up to 405 Days))_
- **Number of Participants With Symptomatic and Asymptomatic Cerebral Emboli** _(time frame: Up to 405 Days)_
- **Number of Participants With New or Worsening Neurologic Deficits** _(time frame: Pre-procedure, discharge, 1 Month, 3 Month and 6 Month)_
- **Number of Participants With NIHSS Scores** _(time frame: Pre-procedure and at discharge (Up to 405 Days))_
- **Number of Participants With MoCA Scores** _(time frame: Up to 405 Days)_
- **Number of Participants With Hospitalization for Cardiovascular Events** _(time frame: Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days))_
- **Percentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants** _(time frame: Up to 405 Days)_
- **Percentage of Participants With Use of Focal Catheter Ablation for Non-PV Triggers** _(time frame: Up to 405 Days)_
- **Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atypical (Left Side) Atrial Flutter (AFL) Episodes or Documented Symptomatic AF/AT/AFL** _(time frame: Up to 6 Months)_
- **Percentage of Participants With Freedom From Documented, AF, AT, or Atypical (Left Side) AFL Episodes or Documented Symptomatic AF/AT/AFL** _(time frame: Up to 12 Months)_

## 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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.na homolce hospital|prague||czechia` — added _(2026-05-12)_
- `locations.ospedale "f. miulli"|bari||italy` — added _(2026-05-12)_
- `locations.centro cardiologico monzino|milan||italy` — added _(2026-05-12)_
- `locations.liverpool heart and chest hospital|liverpool||united kingdom` — added _(2026-05-12)_
- `locations.bart's health nhs trust|london||united kingdom` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03437733.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03437733*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*