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

NCT06567652 | Completed

• 1 other identifier: PolarXpersistent
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Effectiveness

  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

  1 year follow-up

• Safety of the procedure

  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.

  The safety endpoint was evaluated at 7-days 30-days and 1-year follow-up

Interventions

catheter ablation DEVICE

All patients underwent pulmonary vein isolation (and eventually left atrial posterior wall isolation) with the POLARx™ cryoballoon system

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Persistent atrial fibrillation patients undergoing first atrial fibrillation ablation procedure with PolarX cryoballoon

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel Heart Rhythm Management Center

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the department: Heart Rhythm Management Centre, Postgraduate Course in Cardiac Electrophysiology and Pacing, Vrije Universiteit Brussel, Universitair Ziekenhuis

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 23, 2024
• Study Start: January 1, 2021
• Primary Completion: August 31, 2022
• Study Completion: September 1, 2022
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)