Atrial FibrillationNCT06183879
Comparison of Expandable and Fixed Size Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation
A study testing cryoballoon pulmonary vein isolation (Medtronic 4th gen balloon) and cryoballoon pulmonary vein isolation (Boston 2nd gen balloon) in people with Atrial Fibrillation, run by University of Zagreb at 2 sites in Croatia.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- cryoballoon pulmonary vein isolation (Medtronic 4th gen balloon) and cryoballoon pulmonary vein isolation (Boston 2nd gen balloon)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesCroatia
- Study dates
- 1 Jan 2024to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- paroxysmal atrial fibrillation
- patient scheduled for cryoballoon pulmonary vein isolation regardless of this study
Who cannot join
- unwilling to sing the informed consent Left atrium size > 55 mm Uncontrolled heart failure (NYHA III-IV) Intracardiac thrombi
Trial locations and contacts
2 sites in 1 country.
Croatia2 sites, 2 recruiting
- Recruiting
KB Dubrava
Zagreb, Please Select, 10000
Ante Lisicic, MD, +385915710116, antelisicic1980@gmail.com
- Recruiting
KBC Zagreb
Zagreb, 10000
Vedran Velagić, MD, PhD, 0917929284, vvelagic@gmail.com
Ivan Prepolec, MD
About this study
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:
Read more
- 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.
Read the 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.
- Conditions
- Atrial Fibrillation
- Being tested
- cryoballoon pulmonary vein isolation (Medtronic 4th gen balloon), cryoballoon pulmonary vein isolation (Boston 2nd gen balloon)
- Keywords
- atrial fibrillation, ablation, cryoballoon
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryoballoon pulmonary vein isolation (Medtronic 4th gen balloon)Device
Standard of care cryoballoon pulmonary vein isolation with Medtronic 4th gen balloon
cryoballoon pulmonary vein isolation (Boston 2nd gen balloon)Device
Standard of care cryoballoon pulmonary vein isolation with Boston 2nd gen balloon
| Study group | Role | What they receive |
|---|---|---|
| Medtronic 4th gen balloon | Active comparator | Cryoballoon pulmonary vein isolation with Medtronic Artic Front Advance Pro 28 mm fixed size cryoballoon Receives: Device: cryoballoon pulmonary vein isolation (Medtronic 4th gen balloon) |
| Boston 2nd gen balloon | Active comparator | Cryoballoon pulmonary vein isolation with Polar X Fit, 28 to 31 mm expandable cryoballoon Receives: Device: cryoballoon pulmonary vein isolation (Boston 2nd gen balloon) |
What is being measured
The primary outcome is the main question the study is designed to answer.
acute success
successful pulmonary vein isolation, as percentage of all pulmonary veins treated
Measured: 1 week
mid term success
number of patients free from atrial arrhythmia (atrial fibrillation detected by ECG or Holter monitors on follow up visits)
Measured: 1 year. Outpatient visits planned on 90, 180 and 360 days.
Secondary outcomes (5)
procedure duration
duration of the procedure in minutes
Measured: 1 week
fluoroscopy time
fluoroscopy time (minutes)
Measured: 1 week
complications
number of minor (groin hematoma, chest pain, etc) or major complications (tamponade, phrenic nerve palsy, etc)
Measured: 1 year
ablation time
cumulative time of cryo applications in seconds
Measured: 1 week
radiation dosage
radiation dosage (microGrays-m2)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start1 Jan 2024
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization to two different cryoballoon devices
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zagreb
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vedran Velagic, University of Zagreb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183879
- Sponsor's protocol ID
- PolarvsAFA
- Status last verified
- May 2024
- First submitted
- 20 Nov 2023
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Expandable and Fixed Size Cryoballoon for the Treatment of Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT06183879
- Acronym / sponsor ID
- PolarvsAFA
- Conditions
- Atrial Fibrillation
- Keywords
- atrial fibrillation, ablation, cryoballoon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of ZagrebUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 28 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomization to two different cryoballoon devices
| Arm | Type | Receives |
|---|---|---|
| Medtronic 4th gen balloon | Active comparator | Device: cryoballoon pulmonary vein isolation (Medtronic 4th gen balloon)Cryoballoon pulmonary vein isolation with Medtronic Artic Front Advance Pro 28 mm fixed size cryoballoon |
| Boston 2nd gen balloon | Active comparator | Device: cryoballoon pulmonary vein isolation (Boston 2nd gen balloon)Cryoballoon pulmonary vein isolation with Polar X Fit, 28 to 31 mm expandable cryoballoon |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- paroxysmal atrial fibrillation
- patient scheduled for cryoballoon pulmonary vein isolation regardless of this study
Key exclusion criteria (1 listed)
- unwilling to sing the informed consent Left atrium size > 55 mm Uncontrolled heart failure (NYHA III-IV) Intracardiac thrombi
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryoballoon pulmonary vein isolation (Medtronic 4th gen balloon)Standard of care cryoballoon pulmonary vein isolation with Medtronic 4th gen balloon | Device | Medtronic 4th gen balloon |
| cryoballoon pulmonary vein isolation (Boston 2nd gen balloon)Standard of care cryoballoon pulmonary vein isolation with Boston 2nd gen balloon | Device | Boston 2nd gen balloon |
Primary outcome
acute success
Time frame: 1 week
successful pulmonary vein isolation, as percentage of all pulmonary veins treated
mid term success
Time frame: 1 year. Outpatient visits planned on 90, 180 and 360 days.
number of patients free from atrial arrhythmia (atrial fibrillation detected by ECG or Holter monitors on follow up visits)
5 secondary outcomes
procedure duration
Time frame: 1 week
fluoroscopy time
Time frame: 1 week
complications
Time frame: 1 year
ablation time
Time frame: 1 week
radiation dosage
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryoballoon pulmonary vein isolation (Medtronic 4th gen balloon) and cryoballoon pulmonary vein isolation (Boston 2nd gen balloon) in people with Atrial Fibrillation, run by University of Zagreb at 2 sites in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vedran Velagic, MD, PhD (+385917929284, vvelagic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute success (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024; AzTrials last refreshed its copy on 7 Nov 2026.