Paroxysmal Atrial FibrillationC-frostNCT01920295
Safety and Efficacy of Cryoballoon Ablation of Atrial Fibrillation as First-line Therapy
A study testing Cryoballoon ablation in people with Paroxysmal Atrial Fibrillation, run by Yuksek Ihtisas Hospital at 1 site in Turkey (Türkiye).
Trial summary
Cryoballoon ablation of paroxysmal atrial fibrillation can be used as first-line therapy compared to second choice after failed medical therapy Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- What is being tested?
- Cryoballoon ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2011to Apr 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- paroxysmal atrial fibrillation, symptomatic
Who cannot join
- atrial fibrillation other than PAF, asymptomatic, previous AF ablation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yuksek Ihtisas Heart-Education and Research Hospital
Ankara, 06100
About this study
Cryoballoon ablation of paroxysmal atrial fibrillation can be used as first-line therapy compared to second choice after failed medical therapy
- Conditions
- Paroxysmal Atrial Fibrillation
- Being tested
- Cryoballoon ablation
- 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 ablationDevice
| Study group | Role | What they receive |
|---|---|---|
| Cryoballoon ablation | Experimental | Cryoballoon ablation Receives: Device: Cryoballoon ablation |
| Cryoballoon after medical therapy | Active comparator | Cryoballoon ablation Receives: Device: Cryoballoon ablation |
| Cryoballoon as first-line therapy | Experimental | Cryoballoon ablation Receives: Device: Cryoballoon ablation |
| Cryoballoon after failed drug therapy | Active comparator | Cryoballoon ablation Receives: Device: Cryoballoon ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)
At prespecified interval of 12th month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring
Measured: 12 months from the procedure
Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)
At prespecified interval of 3rd month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring
Measured: 3 months from the procedure
Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)
At prespecified interval of 6th month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring
Measured: 6 months from the procedure
Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)
At prespecified interval of 9th month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring
Measured: 9 months from the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startJan 2011
- Primary completionMar 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paroxysmal 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuksek Ihtisas Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serkan Cay, Yuksek Ihtisas Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920295
- Sponsor's protocol ID
- 3196568
- Acronym
- C-frost
- Status last verified
- Aug 2013
- First submitted
- 1 May 2013
- Last updated
- 9 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Cryoballoon Ablation of Atrial Fibrillation as First-line Therapy
- ClinicalTrials.gov ID
- NCT01920295
- Acronym / sponsor ID
- C-frost / 3196568
- Conditions
- Paroxysmal Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Yuksek Ihtisas HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 9 Aug 2013 (estimated)
- 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.
Cryoballoon ablation of paroxysmal atrial fibrillation can be used as first-line therapy compared to second choice after failed medical therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cryoballoon ablation | Experimental | Device: Cryoballoon ablationCryoballoon ablation |
| Cryoballoon after medical therapy | Active comparator | Device: Cryoballoon ablationCryoballoon ablation |
| Cryoballoon as first-line therapy | Experimental | Device: Cryoballoon ablationCryoballoon ablation |
| Cryoballoon after failed drug therapy | Active comparator | Device: Cryoballoon ablationCryoballoon ablation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- paroxysmal atrial fibrillation, symptomatic
Key exclusion criteria (1 listed)
- atrial fibrillation other than PAF, asymptomatic, previous AF ablation
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 ablation | Device | Cryoballoon ablation, Cryoballoon after failed drug therapy, Cryoballoon after medical therapy, Cryoballoon as first-line therapy |
Primary outcome
Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)
Time frame: 12 months from the procedure
At prespecified interval of 12th month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring
Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)
Time frame: 3 months from the procedure
At prespecified interval of 3rd month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring
Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)
Time frame: 6 months from the procedure
At prespecified interval of 6th month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring
Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite)
Time frame: 9 months from the procedure
At prespecified interval of 9th month from the index procedure occurence of Recurrent atrial fibrillation, atrial flutter and atrial tachycardia ( Number of Participants with Recurrent atrial fibrillation, atrial flutter and atrial tachycardia )was assessed using ambulatory holter ECG monitoring
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryoballoon ablation in people with Paroxysmal Atrial Fibrillation, run by Yuksek Ihtisas Hospital at 1 site in Turkey (Türkiye).
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 1 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: finished, as of the sponsor's last update on 9 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent atrial fibrillation, atrial flutter and atrial tachycardia (composite) (time frame: 12 months from the procedure). The study lists 4 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 9 Aug 2013.