Comparison of Expandable and Fixed Size Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation
NCT ID: NCT06183879
Last Updated: 2024-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
150 participants
INTERVENTIONAL
2024-01-01
2026-01-01
Brief Summary
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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.
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Detailed Description
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Standard patient and procedural data will be collected alongside with the information obtained in the follow up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Medtronic 4th gen balloon
Cryoballoon pulmonary vein isolation with Medtronic Artic Front Advance Pro 28 mm fixed size cryoballoon
cryoballoon pulmonary vein isolation (Medtronic 4th gen balloon)
Standard of care cryoballoon pulmonary vein isolation with Medtronic 4th gen balloon
Boston 2nd gen balloon
Cryoballoon pulmonary vein isolation with Polar X Fit, 28 to 31 mm expandable cryoballoon
cryoballoon pulmonary vein isolation (Boston 2nd gen balloon)
Standard of care cryoballoon pulmonary vein isolation with Boston 2nd gen balloon
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* patient scheduled for cryoballoon pulmonary vein isolation regardless of this study
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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University of Zagreb
OTHER
Responsible Party
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Vedran Velagic
MD, PhD, Assistant Professor
Locations
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KB Dubrava
Zagreb, Please Select, Croatia
KBC Zagreb
Zagreb, , Croatia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PolarvsAFA
Identifier Type: -
Identifier Source: org_study_id
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