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

August 25, 2024 updated by: Carlo de Asmundis, Universitair Ziekenhuis Brussel
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1090
        • UZ Brussel Heart Rhythm Management Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effectiveness
Time Frame: 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
1 year follow-up
Safety of the procedure
Time Frame: 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.
The safety endpoint was evaluated at 7-days 30-days and 1-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

August 31, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

August 20, 2024

First Submitted That Met QC Criteria

August 20, 2024

First Posted (Actual)

August 23, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 25, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PolarXpersistent

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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