Comparison of Expandable and Fixed Size Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation

The goal of this clinical trial is to compare two different, market approved, cryoballoon devices for the treatment of paroxysmal atrial fibrillation (AF).

The main aims of the study are:

• to compare the efficacy of two ablation devices (acute and 1 year success rates)
• to compare the procedural characteristics (procedure duration, fluoroscopy duration, ablation time
• to compare the complication rates

Participants who have indication for cryoballoon ablation of AF will be randomized in 1:1 fashion to older fixed size cryoballoon and newer expandable cryoballoon. Standard of care cryoballoon procedure will be performed alongside with standard postprocedural follow-up.

• to compare the complication rates

Participants who have indication for cryoballoon ablation of AF will be randomized in 1:1 fashion to older fixed size cryoballoon and newer expandable cryoballoon.

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: cryoballoon pulmonary vein isolation (Medtronic 4th gen balloon); Device: cryoballoon pulmonary vein isolation (Boston 2nd gen balloon)

Detailed Description

Patients suffering from paroxysmal atrial fibrillation who are scheduled (independently of this study) for cryoballoon pulmonary vein isolation will be informed about the study and potential risks. All patients who give written informed consent will be randomized to 4th generation Artic Front Advance Pro device (fixed size balloon of 28 mm) and Polar X Fit device (28-31 mm expandable balloon). The ablation procedure will be performed in standard of care fashion. Also, standard postprocedural follow up of the patients will be scheduled with outpatient clinic visits and 24-hour Holters and 3, 6 and 12 months, and yearly thereafter. Extra visits will be scheduled in the case of symptoms/palpitations.

Standard patient and procedural data will be collected alongside with the information obtained in the follow up.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vedran Velagic, MD, PhD; Phone Number: +385917929284; Email: vvelagic@gmail.com

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • Recruiting
    • KBC Zagreb
    • Contact: Vedran Velagić, MD, PhD; Phone Number: 0917929284; Email: vvelagic@gmail.com
    • Sub-Investigator: Ivan Prepolec, MD
    • Sub-Investigator: Vedran Pasara, MD
  • Please Select
    • Zagreb, Please Select, Croatia, 10000
      • Recruiting
      • KB Dubrava
      • Contact: Ante Lisicic, MD; Phone Number: +385915710116; Email: antelisicic1980@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• paroxysmal atrial fibrillation
• patient scheduled for cryoballoon pulmonary vein isolation regardless of this study

Exclusion Criteria:

• unwilling to sing the informed consent Left atrium size > 55 mm Uncontrolled heart failure (NYHA III-IV) Intracardiac thrombi

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Medtronic 4th gen balloon; Cryoballoon pulmonary vein isolation with Medtronic Artic Front Advance Pro 28 mm fixed size cryoballoon	Device: cryoballoon pulmonary vein isolation (Medtronic 4th gen balloon); Standard of care cryoballoon pulmonary vein isolation with Medtronic 4th gen balloon
Active Comparator: Boston 2nd gen balloon; Cryoballoon pulmonary vein isolation with Polar X Fit, 28 to 31 mm expandable cryoballoon	Device: cryoballoon pulmonary vein isolation (Boston 2nd gen balloon); Standard of care cryoballoon pulmonary vein isolation with Boston 2nd gen balloon

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
acute success	successful pulmonary vein isolation, as percentage of all pulmonary veins treated	1 week
mid term success	number of patients free from atrial arrhythmia (atrial fibrillation detected by ECG or Holter monitors on follow up visits)	1 year. Outpatient visits planned on 90, 180 and 360 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
procedure duration	duration of the procedure in minutes	1 week
fluoroscopy time	fluoroscopy time (minutes)	1 week
complications	number of minor (groin hematoma, chest pain, etc) or major complications (tamponade, phrenic nerve palsy, etc)	1 year
ablation time	cumulative time of cryo applications in seconds	1 week
radiation dosage	radiation dosage (microGrays-m2)	1 week

Collaborators and Investigators

• Sponsor: University of Zagreb

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2026

Study Registration Dates

• First Submitted: November 20, 2023
• First Submitted That Met QC Criteria: December 27, 2023
• First Posted (Actual): December 28, 2023

Study Record Updates

• Last Update Posted (Actual): May 28, 2024
• Last Update Submitted That Met QC Criteria: May 24, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: atrial fibrillation; ablation; cryoballoon
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: PolarvsAFA

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