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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• paroxysmal atrial fibrillation

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

Locations
Other Locations
Croatia
KB Dubrava
RECRUITING
Zagreb
KBC Zagreb
RECRUITING
Zagreb
Contact Information
Primary
Vedran Velagic, MD, PhD
vvelagic@gmail.com
+385917929284
Time Frame
Start Date: 2024-01-01
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 150
Treatments
Active_comparator: Medtronic 4th gen balloon
Cryoballoon pulmonary vein isolation with Medtronic Artic Front Advance Pro 28 mm fixed size cryoballoon
Active_comparator: Boston 2nd gen balloon
Cryoballoon pulmonary vein isolation with Polar X Fit, 28 to 31 mm expandable cryoballoon
Related Therapeutic Areas
Sponsors
Leads: University of Zagreb

This content was sourced from clinicaltrials.gov