Atrial Fibrillation, PersistentNCT04489004
The Chinese Registration Study of Driver Ablation of Persistent Atrial Fibrillation.
A study testing Driver ablation+CPVI and Stepwise ablation in people with Atrial Fibrillation, Persistent, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
This is an open label, multi-center, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Persistent
- What is being tested?
- Driver ablation+CPVI and Stepwise ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,298 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2020to 1 Dec 2022
- 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
- Aged 18 to 80 years old;
- Persistent AF;
- nonresponse or intolerance to ≥1 antiarrhythmic drug. -
Who cannot join
- With uncontrolled congestive heart failure;
- Having significant valvular disease and/or prosthetic heart valve(s);
- With myocardial infarction or stroke within 6 months of screening;
- With Significant congenital heart disease;
- Ejection fraction was <40% measured by echocardiography;
- Allergic to contrast media;
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- Contraindication to anticoagulation medications;
- Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
- Left atrial (LA) thrombus measured by pre-procedure transesophageal echocardiography;
- Having any contraindication to right or left sided heart catheterization;
- Previous atrial fibrillation ablation;
- Presence of an implanted cardioverter-defibrillator;
- Any cardiac surgery within the past 2 months;
- Poor general health;
- Life expectancy less than 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Credit-AF: A Randomized Control Study of Driver Ablation Combined With Circumferential Pulmonary Vein Isolation Versus Stepwise Ablation as a Treatment in Patients With Persistent Atrial Fibrillation.
This is an open label, multi-center, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation.
Read the detailed description
This is an open label, multi-center, randomized parallel control clinical trial. Patients with persistent atrial fibrillation are 1:1 randomized into the experimental group (driver ablation+ circumferential pulmonary vein isolation) or the control group (stepwise ablation). Postoperative atrial fibrillation recurrence rate and other indicators are analyzed to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation.
- Conditions
- Atrial Fibrillation, Persistent
- Being tested
- Driver ablation+CPVI, Stepwise ablation
- Keywords
- Persistent Atrial Fibrillation, Driver ablation, Stepwise 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.
Driver ablation+CPVIProcedure or surgery
Patients receive driver ablation and CPVI (circumferential pulmonary vein isolation).
Stepwise ablationProcedure or surgery
Patients receive stepwise ablation.
| Study group | Role | What they receive |
|---|---|---|
| Driver ablation+CPVI | Experimental | Driver ablation plus CPVI (circumferential pulmonary vein isolation) Receives: Procedure: Driver ablation+CPVI |
| Stepwise ablation | Active comparator | Stepwise ablation Receives: Procedure: Stepwise ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative atrial fibrillation (AF) recurrence rate
AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration.
Measured: up to 24 months after enrollment
Procedural AF termination rate
AF termination is defined as conversion to sinus rhythm or a stable atrial flutter (AFL)/atrial tachycardia (AT).
Measured: Before the end of procedure.
Secondary outcomes (2)
Postoperative atrial flutter (AFL) or atrial tachycardia (AT) rate
Occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration.
Measured: up to 24 months after enrollment
Incidence of complications
Complications include: death, atrioesophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, transient ischemic attack (TIA), diaphragmatic paralysis, pneumothorax, heart block, pulmonary vein stenosis, pulmonary edema, pericarditis, and major vascular access complication or bleeding.
Measured: up to 2 weeks after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start1 Aug 2020
- Primary completion1 Dec 2021
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation, PersistentStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 1,298 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Liu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04489004
- Sponsor's protocol ID
- Credit-AF
- Status last verified
- Feb 2023
- First submitted
- 24 Jul 2020
- Last updated
- 6 Feb 2023
- 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 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Credit-AF: A Randomized Control Study of Driver Ablation Combined With Circumferential Pulmonary Vein Isolation Versus Stepwise Ablation as a Treatment in Patients With Persistent Atrial Fibrillation.
- ClinicalTrials.gov ID
- NCT04489004
- Acronym / sponsor ID
- Credit-AF
- Conditions
- Atrial Fibrillation, Persistent
- Keywords
- Persistent Atrial Fibrillation, Driver ablation, Stepwise ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,298 participants (actual)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 28 Jul 2020 (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.
This is an open label, multi-center, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation.
Detailed description
This is an open label, multi-center, randomized parallel control clinical trial. Patients with persistent atrial fibrillation are 1:1 randomized into the experimental group (driver ablation+ circumferential pulmonary vein isolation) or the control group (stepwise ablation). Postoperative atrial fibrillation recurrence rate and other indicators are analyzed to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Driver ablation+CPVI | Experimental | Procedure: Driver ablation+CPVIDriver ablation plus CPVI (circumferential pulmonary vein isolation) |
| Stepwise ablation | Active comparator | Procedure: Stepwise ablationStepwise ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18 to 80 years old;
- Persistent AF;
- nonresponse or intolerance to ≥1 antiarrhythmic drug. -
Key exclusion criteria (15 listed)
- With uncontrolled congestive heart failure;
- Having significant valvular disease and/or prosthetic heart valve(s);
- With myocardial infarction or stroke within 6 months of screening;
- With Significant congenital heart disease;
- Ejection fraction was <40% measured by echocardiography;
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 |
|---|---|---|
| Driver ablation+CPVIPatients receive driver ablation and CPVI (circumferential pulmonary vein isolation). | Procedure or surgery | Driver ablation+CPVI |
| Stepwise ablationPatients receive stepwise ablation. | Procedure or surgery | Stepwise ablation |
Primary outcome
Postoperative atrial fibrillation (AF) recurrence rate
Time frame: up to 24 months after enrollment
AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration.
Procedural AF termination rate
Time frame: Before the end of procedure.
AF termination is defined as conversion to sinus rhythm or a stable atrial flutter (AFL)/atrial tachycardia (AT).
2 secondary outcomes
Postoperative atrial flutter (AFL) or atrial tachycardia (AT) rate
Time frame: up to 24 months after enrollment
Incidence of complications
Time frame: up to 2 weeks after enrollment
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 6 Feb 2023.
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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 Driver ablation+CPVI and Stepwise ablation in people with Atrial Fibrillation, Persistent, run by Shanghai Chest Hospital 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 3 inclusion and 15 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 6 Feb 2023. 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?
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?
Postoperative atrial fibrillation (AF) recurrence rate (time frame: up to 24 months after enrollment). 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 6 Feb 2023.