Atrial Fibrillationera-cryoNCT05492760
Evaluation of Recurrence Risk of Atrial Fibrillation After Cryoballoon Ablation
An observational study of Atrial Fibrillation, run by Shanghai 10th People's Hospital.
Trial summary
The recurrence of atrial fibrillation(AF) after pulmonary vein ablation with cryoballoon is conducted by many factors . The previous studies found larger left atrial and longer AF duration are tied to higher risk of AF recurrence. 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 ablation
- Type of treatment
- Medical device
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 1 Jul 2024
- Phase
- Observational
- 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
Study population: Patients with paroxysmal AF and accept cryoballoon ablation.
Who may be able to join
- Patients with paroxysmal AF and accept cryoballoon ablation.
Who cannot join
- left atrium (LA) diameter (anterior-to-posterior)>55mm on transthoracic echocardiography (TTE)
- the presence of thrombus in the LA or left atrial appendage (LAA) on transesophageal echocardiography (TEE)
- uncorrected heart failure (NYHA class III or IV),
- concomitant moderate or severe valvular heart disease or bioprosthetic valve,
- malignancy necessitating chemotherapy.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Recurrence Risk of Atrial Fibrillation After Cryoballoon Ablation： a Retrospective Cohort Study
The recurrence of atrial fibrillation(AF) after pulmonary vein ablation with cryoballoon is conducted by many factors . The previous studies found larger left atrial and longer AF duration are tied to higher risk of AF recurrence. The characters of ablation procedure is also of critical importance to durable clinical success such as temperature features and time-to-isolation (TTI). The aim of our study is to develop an tool of recurrence risk evaluation with both pre-procedure and procedure factors.
- Conditions
- 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
Patients with AF will accept cryoballoon ablation.
| Study group | Role | What they receive |
|---|---|---|
| ablation group | Not described Receives: Device: cryoballoon ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
the time to atrial fibrillation recurrent
the time to atrial fibrillation recurrent
Measured: 1year after the cryoballoon ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Jul 2023 (estimated)
- Study completion1 Jul 2024 (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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 10th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Wei Xu, Shanghai 10th People's Hospital
- Investigators
- Yawei Xu, doctor, Study director, Shanghai 10th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05492760
- Sponsor's protocol ID
- era-cryo
- Acronym
- era-cryo
- Status last verified
- Aug 2022
- First submitted
- 31 Jul 2022
- Last updated
- 9 Aug 2022
- Results posted
- 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 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Recurrence Risk of Atrial Fibrillation After Cryoballoon Ablation： a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05492760
- Acronym / sponsor ID
- era-cryo / era-cryo
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Shanghai 10th People's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 9 Aug 2022 (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 recurrence of atrial fibrillation(AF) after pulmonary vein ablation with cryoballoon is conducted by many factors . The previous studies found larger left atrial and longer AF duration are tied to higher risk of AF recurrence. The characters of ablation procedure is also of critical importance to durable clinical success such as temperature features and time-to-isolation (TTI). The aim of our study is to develop an tool of recurrence risk evaluation with both pre-procedure and procedure factors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ablation group | – | Device: cryoballoon ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with paroxysmal AF and accept cryoballoon ablation.
Key inclusion criteria (1 listed)
- Patients with paroxysmal AF and accept cryoballoon ablation.
Key exclusion criteria (5 listed)
- left atrium (LA) diameter (anterior-to-posterior)>55mm on transthoracic echocardiography (TTE)
- the presence of thrombus in the LA or left atrial appendage (LAA) on transesophageal echocardiography (TEE)
- uncorrected heart failure (NYHA class III or IV),
- concomitant moderate or severe valvular heart disease or bioprosthetic valve,
- malignancy necessitating chemotherapy.
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 ablationPatients with AF will accept cryoballoon ablation. | Device | ablation group |
Primary outcome
the time to atrial fibrillation recurrent
Time frame: 1year after the cryoballoon ablation
the time to atrial fibrillation recurrent
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Yawei Xu, doctor study director
Shanghai 10th People's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Shanghai 10th People's Hospital.
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 5 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 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Yawei Xu, doctor (13916698181, xuyawei@tongji.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the time to atrial fibrillation recurrent (time frame: 1year after the cryoballoon ablation). 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 2022.