Safety and Efficacy of Persistent Atrial Fibrillation Ablation With a Cryoballoon Technology

Completed

• Conditions: Atrial Fibrillation

• Registration Number: NCT06567652
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

The goal of this retrospective observational study is to learn about the safety and efficacy of cryoballoon catheter ablation in 80 patients with persistent atrial fibrillation using the PolarX (Boston scientific) cryoablation technology. The main question it aims to answer is if it is safe and effective.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2022-08-31
• Study Completion: 2022-09-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-20
• Study First Submitted QC: 2024-08-20
• Study First Posted: 2024-08-23
• Last Update Submitted: 2024-08-25
• Last Update Posted: 2024-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• persistent atrial fibrillation patients undergoing first atrial fibrillation ablation procedure with PolarX cryoballoon

Exclusion Criteria

• previous atrial fibrillation ablation or cardiac surgery,
• paroxysmal atrial fibrillation,
• congenital heart disease,
• non-treated coronary artery disease,
• intracavitary thrombus,
• significant valvular disease,
• contraindications to general anesthesia.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of the procedure	The safety endpoint was evaluated at 7-days 30-days and 1-year follow-up	Safety is defined as the composite of any of the following occurrences: Death Myocardial infarction Persistent gastroparesis/injury to vagus nerve Stroke/Transient ischemic attack Thromboembolism/ Air embolism Cardiac tamponade/perforation Pneumothorax Serious vascular access complications\* Pulmonary edema/Heart Failure Ablation related atrioventricular block not attributable to medication effect or vasovagal reaction.; Safety events (0-30 days post procedure) Symptomatic pericardial effusion Safety events (0-360 days post procedure) Atrial esophageal fistula Persistent Phrenic nerve injury Pulmonary Vein Stenosis; \* Including hematoma requiring intervention or prolongation of hospital stay, artero-venous fistulas or pseudoaneurysm.
Effectiveness	1 year follow-up	Primary effectiveness failure is defined as the composite of any of the following occurrences: Failure to achieve acute procedural success at the index procedure (pulmonary vein isolation); More than one repeat procedure during the blanking period (within 90 days post-index procedure); Documented atrial fibrillation, or new onset of atrial flutter or atrial tachycardia event (≥ 30 seconds in duration or from a 10 second 12-lead ECG) Repeat procedure for atrial fibrillation, or new onset of atrial flutter or atrial tachycardia Electrical and/or pharmacological cardioversion; • Prescribed a new antiarrhythmic drug not documented at baseline Prescribed a higher dose of antiarrhythmic drug documented at baseline

Trial Locations

Locations (1)

UZ Brussel Heart Rhythm Management Center; 🇧🇪 Brussels, Belgium