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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06183879
• Other study ID #: PolarvsAFA
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: December 2023
• Source: University of Zagreb
• Contact: Vedran Velagic, MD, PhD
• Phone: +385917929284
• Email: vvelagic[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• cryoballoon pulmonary vein isolation (Medtronic 4th gen balloon)
Standard of care cryoballoon pulmonary vein isolation with Medtronic 4th gen balloon
• cryoballoon pulmonary vein isolation (Boston 2nd gen balloon)
Standard of care cryoballoon pulmonary vein isolation with Boston 2nd gen balloon

Locations

Country	Name	City	State
Croatia	KB Dubrava	Zagreb	Please Select
Croatia	KBC Zagreb	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
University of Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	acute success	successful pulmonary vein isolation, as percentage of all pulmonary veins treated	1 week
Primary	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	procedure duration	duration of the procedure in minutes	1 week
Secondary	fluoroscopy time	fluoroscopy time (minutes)	1 week
Secondary	complications	number of minor (groin hematoma, chest pain, etc) or major complications (tamponade, phrenic nerve palsy, etc)	1 year
Secondary	ablation time	cumulative time of cryo applications in seconds	1 week
Secondary	radiation dosage	radiation dosage (microGrays-m2)	1 week