Comparison of Expandable and Fixed Size Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation
1 other identifier
interventional
150
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Jan 2024
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 20, 2023
CompletedFirst Posted
Study publicly available on registry
December 28, 2023
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedMay 28, 2024
May 1, 2024
1 year
November 20, 2023
May 24, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
procedure duration
1 week
fluoroscopy time
1 week
complications
1 year
ablation time
1 week
radiation dosage
1 week
Study Arms (2)
Medtronic 4th gen balloon
ACTIVE COMPARATORCryoballoon pulmonary vein isolation with Medtronic Artic Front Advance Pro 28 mm fixed size cryoballoon
Boston 2nd gen balloon
ACTIVE COMPARATORCryoballoon pulmonary vein isolation with Polar X Fit, 28 to 31 mm expandable cryoballoon
Interventions
Standard of care cryoballoon pulmonary vein isolation with Medtronic 4th gen balloon
Standard of care cryoballoon pulmonary vein isolation with Boston 2nd gen balloon
Eligibility Criteria
You may qualify if:
- paroxysmal atrial fibrillation
- patient scheduled for cryoballoon pulmonary vein isolation regardless of this study
You may not qualify if:
- unwilling to sing the informed consent Left atrium size \> 55 mm Uncontrolled heart failure (NYHA III-IV) Intracardiac thrombi
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
KB Dubrava
Zagreb, Please Select, 10000, Croatia
KBC Zagreb
Zagreb, 10000, Croatia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Assistant Professor
Study Record Dates
First Submitted
November 20, 2023
First Posted
December 28, 2023
Study Start
January 1, 2024
Primary Completion
January 1, 2025
Study Completion
January 1, 2026
Last Updated
May 28, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share