Atrial Fibrillation, PersistentCLEAR AF IINCT05468528
Clinical Value of Linear Ablation Without Pulmonary Vein Isolation in Persistent Atrial Fibrillation
A study testing catheter radiofrequency ablation(individualized stepwise linear without pulmonary vein isolation) and catheter radiofrequency ablation(PVI) in people with Atrial Fibrillation, Persistent and Atrial Fibrillation, run by China National Center for Cardiovascular Diseases at 1 site in China.
Trial summary
Based on previous theoretical foundation and clinical practice experience, the investigators further propose a multi-center randomized prospective trial to compare the pure linear ablation strategy without pulmonary vein isolation to traditional PVI ablation for persistent AF. population size is 207. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Persistent, Atrial Fibrillation
- What is being tested?
- catheter radiofrequency ablation(individualized stepwise linear without pulmonary vein isolation) and catheter radiofrequency ablation(PVI)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 1 Jul 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients suffering from persistent atrial fibrillation and referred to catheter ablation therapy.
- patients agreeing to be enrolled， with the informed consent signed
Who cannot join
- Sinus rhythm at the time of recruitment;
- Age less than 18 years old or older than 75 years;
- Transthoracic echocardiography suggests that the anteroposterior diameter of the left atrium is greater than 55 mm;
- History of previous radiofrequency ablation of atrial fibrillation or surgical ablation History;
- Left atrial thrombus recorded by ultrasound or CT;
- Combined with severe lung disease;
- Previous history of cardiac surgery;
- Patients with hyperthyroidism, atrial septal defect, mitral stenosis, or severe coronary heart disease requiring further treatment
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing
About this study
Official title: Clinical Value of Linear Ablation Without Pulmonary Vein Isolation in Persistent Atrial
Based on previous theoretical foundation and clinical practice experience, the investigators further propose a multi-center randomized prospective trial to compare the pure linear ablation strategy without pulmonary vein isolation to traditional PVI ablation for persistent AF. population size is 207. The participants will be randomized to the linear ablation group and PVI ablation group with a 2:1 ratio. the follow-up period is 12 months. The primary outcome is freedom from atrial fibrillation, the secondary outcome is complications related to ablation.
Read the detailed description
Pulmonary vein isolation is recommended as the cornerstone of catheter ablation of atrial fibrillation by current guidelines, However, meta-analysis suggests that the success rate of continuous pulmonary vein isolation for persistent atrial fibrillation is only 43%. Therefore, in addition to pulmonary vein isolation, further research on substrate modification in the treatment of atrial fibrillation is particularly important.
Based on our previous theoretical foundation and clinical practice experience, the investigators further propose a multi-center randomized prospective trial to compare the pure linear ablation strategy without pulmonary vein isolation to traditional PVI ablation for persistent AF. The linear ablation is performed on the basis of Ω-type linear ablation. Further stepwise ablation of the left atrial anterior wall increases the blockage of the LA roof and the MVA isthmus. Ablation in CS or ethanol ablation of vein of Marshall. Also, epicardial ablation on the roof or rigid between LAA-LPVs may be applied if necessary.
- Being tested
- catheter radiofrequency ablation(individualized stepwise linear without pulmonary vein isolation), catheter radiofrequency ablation(PVI)
- Keywords
- linear 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.
catheter radiofrequency ablation(individualized stepwise linear without pulmonary vein isolation)Procedure or surgery
individualized stepwise linear ablation without pulmonary vein isolation
catheter radiofrequency ablation(PVI)Procedure or surgery
pulmonary vein isolation
| Study group | Role | What they receive |
|---|---|---|
| linear ablation group | Experimental | The linear ablation is performed on the basis of Ω-type linear ablation. Further stepwise ablation of the left atrial anterior wall increases the blockage of the LA roof and the MVA isthmus. Ablation in CS or ethanol ablation of vein of Marshall. Also, epicardial ablation on the roof or rigid between LAA-LPVs may be applied if necessary. Receives: Procedure: catheter radiofrequency ablation(individualized stepwise linear without pulmonary vein isolation) |
| PVI group | Other | pulmonary vein isolation ablation alone Receives: Procedure: catheter radiofrequency ablation(PVI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from atrial fibrillation at 1 year
Recurrent AF is defined as documented AF (through 12-lead ECG) episode lasting >30 seconds after a 3-month blanking period.
Measured: 12 months after the ablation
Secondary outcomes (1)
complications related to ablation
Tamponade, pericarditis and perforation following the ablation procedure
Measured: 12 months after the ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 May 2024 (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 Fibrillation, PersistentStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 207 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, ZHONGNANSHAN MEDICAL FOUNDATION OF GUANGDONG PROVINCE, Beijing Hospital, Wuhan Asia Heart Hospital, Tianjin Medical University General Hospital, Fuwai Yunnan Cardiovascular Hospital, RenJi Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468528
- Sponsor's protocol ID
- 2021-1627
- Acronym
- CLEAR AF II
- Status last verified
- Jul 2022
- First submitted
- 14 Jun 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value of Linear Ablation Without Pulmonary Vein Isolation in Persistent Atrial
- ClinicalTrials.gov ID
- NCT05468528
- Acronym / sponsor ID
- CLEAR AF II / 2021-1627
- Keywords
- linear ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, ZHONGNANSHAN MEDICAL FOUNDATION OF GUANGDONG PROVINCE, Beijing Hospital, Wuhan Asia Heart Hospital, Tianjin Medical University General Hospital, Fuwai Yunnan Cardiovascular Hospital, RenJi Hospital, Chinese Academy of Medical Sciences, Fuwai Hospital
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 May 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 21 Jul 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.
Based on previous theoretical foundation and clinical practice experience, the investigators further propose a multi-center randomized prospective trial to compare the pure linear ablation strategy without pulmonary vein isolation to traditional PVI ablation for persistent AF. population size is 207. The participants will be randomized to the linear ablation group and PVI ablation group with a 2:1 ratio. the follow-up period is 12 months. The primary outcome is freedom from atrial fibrillation, the secondary outcome is complications related to ablation.
Detailed description
Pulmonary vein isolation is recommended as the cornerstone of catheter ablation of atrial fibrillation by current guidelines, However, meta-analysis suggests that the success rate of continuous pulmonary vein isolation for persistent atrial fibrillation is only 43%. Therefore, in addition to pulmonary vein isolation, further research on substrate modification in the treatment of atrial fibrillation is particularly important.
Based on our previous theoretical foundation and clinical practice experience, the investigators further propose a multi-center randomized prospective trial to compare the pure linear ablation strategy without pulmonary vein isolation to traditional PVI ablation for persistent AF. The linear ablation is performed on the basis of Ω-type linear ablation. Further stepwise ablation of the left atrial anterior wall increases the blockage of the LA roof and the MVA isthmus. Ablation in CS or ethanol ablation of vein of Marshall. Also, epicardial ablation on the roof or rigid between LAA-LPVs may be applied if necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| linear ablation group | Experimental | Procedure: catheter radiofrequency ablation(individualized stepwise linear without pulmonary vein isolation)The linear ablation is performed on the basis of Ω-type linear ablation. Further stepwise ablation of the left atrial anterior wall increases the blockage of the LA roof and the MVA isthmus. Ablation in CS or ethanol ablation of vein of Marshall. Also, epicardial ablation on the roof or rigid between LAA-LPVs may be applied if necessary. |
| PVI group | Other | Procedure: catheter radiofrequency ablation(PVI)pulmonary vein isolation ablation alone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients suffering from persistent atrial fibrillation and referred to catheter ablation therapy.
- patients agreeing to be enrolled， with the informed consent signed
Key exclusion criteria (8 listed)
- Sinus rhythm at the time of recruitment;
- Age less than 18 years old or older than 75 years;
- Transthoracic echocardiography suggests that the anteroposterior diameter of the left atrium is greater than 55 mm;
- History of previous radiofrequency ablation of atrial fibrillation or surgical ablation History;
- Left atrial thrombus recorded by ultrasound or CT;
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 |
|---|---|---|
| catheter radiofrequency ablation(individualized stepwise linear without pulmonary vein isolation)individualized stepwise linear ablation without pulmonary vein isolation | Procedure or surgery | linear ablation group |
| catheter radiofrequency ablation(PVI)pulmonary vein isolation | Procedure or surgery | PVI group |
Primary outcome
Freedom from atrial fibrillation at 1 year
Time frame: 12 months after the ablation
Recurrent AF is defined as documented AF (through 12-lead ECG) episode lasting >30 seconds after a 3-month blanking period.
1 secondary outcome
complications related to ablation
Time frame: 12 months after the ablation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Individual participant dataSharing planned: Undecided
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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 catheter radiofrequency ablation(individualized stepwise linear without pulmonary vein isolation) and catheter radiofrequency ablation(PVI) in people with Atrial Fibrillation, Persistent and Atrial Fibrillation, run by China National Center for Cardiovascular Diseases 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 2 inclusion and 8 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 21 Jul 2022. 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?
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?
Freedom from atrial fibrillation at 1 year (time frame: 12 months after the 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 21 Jul 2022.