Persistent Atrial FibrillationNCT05085912
Driver Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis.
A study testing Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation, Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation and Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion in people with Persistent Atrial Fibrillation, run by Shanghai Chest Hospital.
Trial summary
This is an open label, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Persistent Atrial Fibrillation
- What is being tested?
- Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation, Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation and Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2021to 31 Oct 2024
- 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 with severe atrial fibrosis;
- Nonresponse or intolerance to ≥1 antiarrhythmic drug.
Who cannot join
- With uncontrolled congestive heart failure;
- Having significant valvular disease;
- 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;
Show all 11Show fewer
- Contraindication to anticoagulation medications;
- Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
- Left atrial (LA) thrombus;
- Having any contraindication to right or left sided heart catheterization; 11. Previous atrial fibrillation ablation;
- 12. Presence of an implanted cardioverter-defibrillator; 13. Previous history of cardiac surgery; 14. Poor general health; 15. Life expectancy less than 6 months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized Control Study of Driver Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis: a Chinese Registry Study.
This is an open label, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation with severe atrial fibrosis.
Read the detailed description
This is an open label, randomized parallel control clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are 1:1:1 randomized into group A (circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation), group B (circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation) and group C (circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion). Postoperative recurrence rate and other indicators are analyzed to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation with severe atrial fibrosis.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation, Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation, Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion
- Keywords
- persistent atrial fibrillation, severe atrial fibrosis, driver 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.
Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablationProcedure or surgery
Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with bi-atrial mapping and driver ablation.
Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolationProcedure or surgery
Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with posterior wall box isolation.
Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusionProcedure or surgery
Patients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with vein of Marshall ethanol infusion.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation Receives: Procedure: Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation |
| Group B | Active comparator | Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation Receives: Procedure: Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation |
| Group C | Active comparator | Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion Receives: Procedure: Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate
AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration
Measured: up to 12 months after ablation
Intraoperative AF termination rate
AF termination is defined as conversion to sinus rhythm or stable AFL/AT.
Measured: through ablation completion, an average of 3 hours
Secondary outcomes (5)
Postoperative AF recurrence rate
AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration
Measured: up to 12 months after ablation
Postoperative AFL/AT rate
occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration
Measured: up to 12 months after ablation
Incidence of complications
death, atrioesophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, diaphragmatic paralysis, pneumothorax, heart block, pulmonary vein stenosis, pulmonary edema, pericarditis and major vascular access complication or bleeding
Measured: up to 12 months after ablation
Changes in the diameter of the left atrium
Changes in the diameter of the left atrium
Measured: up to 12 months after ablation
Changes in the left ventricular ejection fraction
Changes in the left ventricular ejection fraction
Measured: up to 12 months after ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start1 Nov 2021 (estimated)
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (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.
- 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
- 300 participants (estimated)
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
- NCT05085912
- Sponsor's protocol ID
- DAAF
- Status last verified
- Oct 2021
- First submitted
- 5 Oct 2021
- Last updated
- 20 Oct 2021
- 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 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Study of Driver Ablation of Persistent Atrial Fibrillation With Severe Atrial Fibrosis: a Chinese Registry Study.
- ClinicalTrials.gov ID
- NCT05085912
- Acronym / sponsor ID
- DAAF
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- persistent atrial fibrillation, severe atrial fibrosis, driver ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Nov 2021 (estimated)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 20 Oct 2021 (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, randomized parallel control clinical trial, to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis, and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation with severe atrial fibrosis.
Detailed description
This is an open label, randomized parallel control clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are 1:1:1 randomized into group A (circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation), group B (circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation) and group C (circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion). Postoperative recurrence rate and other indicators are analyzed to demonstrate the role of driver mechanism in maintenance substrate of persistent atrial fibrillation with severe atrial fibrosis and evaluate the clinical outcomes of driver mapping and ablation strategy in patients with persistent atrial fibrillation with severe atrial fibrosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablationCircumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation |
| Group B | Active comparator | Procedure: Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolationCircumferential pulmonary vein isolation + linear ablation + posterior wall box isolation |
| Group C | Active comparator | Procedure: Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusionCircumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion |
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 with severe atrial fibrosis;
- Nonresponse or intolerance to ≥1 antiarrhythmic drug.
Key exclusion criteria (11 listed)
- With uncontrolled congestive heart failure;
- Having significant valvular disease;
- 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 |
|---|---|---|
| Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablationPatients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with bi-atrial mapping and driver ablation. | Procedure or surgery | Group A |
| Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolationPatients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with posterior wall box isolation. | Procedure or surgery | Group B |
| Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusionPatients receive circumferential pulmonary vein isolation and linear ablation (ablation of a roof line and a mitral isthmus line) combined with vein of Marshall ethanol infusion. | Procedure or surgery | Group C |
Primary outcome
Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate
Time frame: up to 12 months after ablation
AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration
Intraoperative AF termination rate
Time frame: through ablation completion, an average of 3 hours
AF termination is defined as conversion to sinus rhythm or stable AFL/AT.
5 secondary outcomes
Postoperative AF recurrence rate
Time frame: up to 12 months after ablation
Postoperative AFL/AT rate
Time frame: up to 12 months after ablation
Incidence of complications
Time frame: up to 12 months after ablation
Changes in the diameter of the left atrium
Time frame: up to 12 months after ablation
Changes in the left ventricular ejection fraction
Time frame: up to 12 months after ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Circumferential pulmonary vein isolation + linear ablation + bi-atrial mapping + driver ablation, Circumferential pulmonary vein isolation + linear ablation + posterior wall box isolation and Circumferential pulmonary vein isolation + linear ablation + vein of Marshall ethanol infusion in people with Persistent Atrial Fibrillation, run by Shanghai Chest 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 3 inclusion and 11 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 20 Oct 2021. 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 Mu Qin, M.D. (+8613052320103, qinmuae@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate (time frame: up to 12 months after ablation). 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 20 Oct 2021.