Persistent Atrial FibrillationNCT03053570
Study Comparing Pulmonary Vein Isolation With the Cryoballoon and Radiofrequency Energy(Contact Force) in the Treatment of Persistent Atrial Fibrillation (AF) (Cryo Vs CF in PerAF)
A study testing Cryoballoon and Radiofrequency Energy(Contact Force) in people with Persistent Atrial Fibrillation, run by China Cardiometabolic Registries at 1 site in China.
Trial summary
The purpose of this study is to perform a prospective, randomised study investigating the safety and efficacy of cryoballoon catheter ablation compared with radiofrequency ablation(contact force), in the treatment of persistent AF. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Cryoballoon and Radiofrequency Energy(Contact Force)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to 31 Dec 2018
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- persistent Atrial Fibrillation; Intolerant to antiarrhythmic medication; Both male or female; Age from 18 to 75 years old.
Who cannot join
- Acute myocardial infarction; Coronary artery stent history; Acute severe stroke; Abnormal liver and renal function.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830011
Baopeng Tang
About this study
Official title: Study Comparing Pulmonary Vein Isolation With the Cryoballoon and Radiofrequency Energy(Contact Force) in the Treatment of Persistent Atrial Fibrillation (PerAF)
The purpose of this study is to perform a prospective, randomised study investigating the safety and efficacy of cryoballoon catheter ablation compared with radiofrequency ablation(contact force), in the treatment of persistent AF.
Read the detailed description
The hypotheses for this study is that cryothermal energy is as effective and safe as using radiofrequency energy in the treatment of persistent AF and is associated with a better long term outcome.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Cryoballoon, Radiofrequency Energy(Contact Force)
- Keywords
- Cryoballoon, Contact Force, Persistent Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoballoonDevice
use Cryoballoon to isolation the Pulmonary Vein
Radiofrequency Energy(Contact Force)Device
use Radiofrequency Energy(Contact Force) to isolation the Pulmonary Vein
| Study group | Role | What they receive |
|---|---|---|
| Cryoballoon | Experimental | Not described Receives: Device: Cryoballoon; Device: Radiofrequency Energy(Contact Force) |
| Radiofrequency Energy(Contact Force) | Experimental | Not described Receives: Device: Cryoballoon; Device: Radiofrequency Energy(Contact Force) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with successful Pulmonary Vein Isolation
Measured: in one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start1 Mar 2017 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Cardiometabolic Registries
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Baopeng Tang, Study chair, First Affiliated Hospital of Xinjiang Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03053570
- Sponsor's protocol ID
- Cryo Vs CF in PerAF
- Status last verified
- Feb 2017
- First submitted
- 31 Jan 2017
- Last updated
- 15 Feb 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Comparing Pulmonary Vein Isolation With the Cryoballoon and Radiofrequency Energy(Contact Force) in the Treatment of Persistent Atrial Fibrillation (PerAF)
- ClinicalTrials.gov ID
- NCT03053570
- Acronym / sponsor ID
- Cryo Vs CF in PerAF
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- Cryoballoon, Contact Force, Persistent Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- China Cardiometabolic RegistriesResearch network
- Study start
- 1 Mar 2017 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 15 Feb 2017 (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 purpose of this study is to perform a prospective, randomised study investigating the safety and efficacy of cryoballoon catheter ablation compared with radiofrequency ablation(contact force), in the treatment of persistent AF.
Detailed description
The hypotheses for this study is that cryothermal energy is as effective and safe as using radiofrequency energy in the treatment of persistent AF and is associated with a better long term outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoballoon | Experimental | Device: Cryoballoon, Device: Radiofrequency Energy(Contact Force) |
| Radiofrequency Energy(Contact Force) | Experimental | Device: Cryoballoon, Device: Radiofrequency Energy(Contact Force) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- persistent Atrial Fibrillation; Intolerant to antiarrhythmic medication; Both male or female; Age from 18 to 75 years old.
Key exclusion criteria (1 listed)
- Acute myocardial infarction; Coronary artery stent history; Acute severe stroke; Abnormal liver and renal function.
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 |
|---|---|---|
| Cryoballoonuse Cryoballoon to isolation the Pulmonary Vein | Device | Cryoballoon, Radiofrequency Energy(Contact Force) |
| Radiofrequency Energy(Contact Force)use Radiofrequency Energy(Contact Force) to isolation the Pulmonary Vein | Device | Cryoballoon, Radiofrequency Energy(Contact Force) |
Primary outcome
Number of participants with successful Pulmonary Vein Isolation
Time frame: in one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
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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.
Baopeng Tang study chair
First Affiliated Hospital of Xinjiang Medical University
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 and Radiofrequency Energy(Contact Force) in people with Persistent Atrial Fibrillation, run by China Cardiometabolic Registries at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 15 Feb 2017. 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 China. 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 Baopeng Tang, PhD (+86 13579881111, tangbaopeng1111@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with successful Pulmonary Vein Isolation (time frame: in one year). 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 15 Feb 2017.