Persistent Atrial FibrillationNCT05454111
CARTO-Finder Guided Ablation Versus Multiscale Entropy Guided Ablation in Persistent Atrial Fibrillation
A study testing Multiscale entropy-guided ablation plus PVI and CARTO-Finder-guided ablation plus PVI in people with Persistent Atrial Fibrillation, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
This is a randomized control trial to compare the efficacy and safety of CARTO-Finder-guided ablation plus pulmonary vein isolation versus multiscale entropy (MSE)-guided pulmonary vein isolation 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
- Persistent Atrial Fibrillation
- What is being tested?
- Multiscale entropy-guided ablation plus PVI and CARTO-Finder-guided ablation plus PVI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 31 Dec 2025
- 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;
- Having moderate-to-severe pulmonary hypertension;
- With myocardial infarction or stroke within 6 months of screening;
- With Significant congenital heart disease;
- Ejection fraction was <40% measured by echocardiography;
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- Allergic to contrast media;
- Contraindication to anticoagulation medications;
- Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
- Left atrial thrombus;
- Having any contraindication to right or left sided heart catheterization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Control Trial to Compare the Efficacy and Safety of CARTO-Finder-guided Ablation Plus Pulmonary Vein Isolation and Multiscale Entropy-guided Ablation Plus Pulmonary Vein Isolation in Patients With Persistent Atrial Fibrillation
This is a randomized control trial to compare the efficacy and safety of CARTO-Finder-guided ablation plus pulmonary vein isolation versus multiscale entropy (MSE)-guided pulmonary vein isolation in patients with persistent atrial fibrillation.
Read the detailed description
This is a randomized control trial. Patients with persistent atrial fibrillation are enrolled and randomized to CARTO-Finder-guided ablation plus PVI group or MSE-guided ablation plus PVI group. Postoperative recurrence rate and other indicators are analyzed to compare the efficacy and safety between CARTO-Finder-guided ablation plus PVI and MSE-guided ablation plus PVI in patients with persistent atrial fibrillation.
- Conditions
- Persistent Atrial Fibrillation
- Being tested
- Multiscale entropy-guided ablation plus PVI, CARTO-Finder-guided ablation plus PVI
- Keywords
- persistent atrial fibrillation, catheter ablation, CARTO-Finder-guided ablation, Multiscale entropy-guided 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.
Multiscale entropy-guided ablation plus PVIProcedure or surgery
The multiscale entropy is calculated based on intracardiac electrical signals, higher multiscale entropy value indicates closer to the core of rotors which maintains the persistent atrial fibrillation.
CARTO-Finder-guided ablation plus PVIProcedure or surgery
CARTO-Finder-guided ablation plus PVI
| Study group | Role | What they receive |
|---|---|---|
| CARTO-Finder-guided ablation plus PVI | Active comparator | Pulmonary vein circumferential isolation + + ablation of sites recognized by CARTO-Finder module as the core of rotors. Receives: Procedure: CARTO-Finder-guided ablation plus PVI |
| Multiscale entropy-guided ablation plus PVI | Experimental | Pulmonary vein circumferential isolation + ablation of sites recognized by multiscale entropy analysis as the core of rotors. Receives: Procedure: Multiscale entropy-guided ablation plus PVI |
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 24 months after enrollment
Secondary outcomes (2)
Postoperative 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
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 24 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start1 Sep 2022 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shandong University of Traditional Chinese Medicine, Department of Cardiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Wuhan Central Hospital, Affiliated Hospital of Jining Medical University, Department of Cardiology, Yuhuan Second People's Hospital, Department of Cardiology, Changshu Hospital of Traditional Chinese Medicine, Department of Cardiology, The PLA Navy Anqing Hospital, Department of Cardiology, Jinan City People's Hospital, Department of Cardiology, Xuzhou Central Hospital
- Responsible party
- Principal investigator, Xu Liu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454111
- Sponsor's protocol ID
- Find-AF
- Status last verified
- Jul 2022
- First submitted
- 5 Jul 2022
- Last updated
- 12 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 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial to Compare the Efficacy and Safety of CARTO-Finder-guided Ablation Plus Pulmonary Vein Isolation and Multiscale Entropy-guided Ablation Plus Pulmonary Vein Isolation in Patients With Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT05454111
- Acronym / sponsor ID
- Find-AF
- Conditions
- Persistent Atrial Fibrillation
- Keywords
- persistent atrial fibrillation, catheter ablation, CARTO-Finder-guided ablation, Multiscale entropy-guided ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Collaborators
- Shandong University of Traditional Chinese Medicine, Department of Cardiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Wuhan Central Hospital, Affiliated Hospital of Jining Medical University, Department of Cardiology, Yuhuan Second People's Hospital, Department of Cardiology, Changshu Hospital of Traditional Chinese Medicine, Department of Cardiology, The PLA Navy Anqing Hospital, Department of Cardiology, Jinan City People's Hospital, Department of Cardiology, Xuzhou Central Hospital
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 12 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.
This is a randomized control trial to compare the efficacy and safety of CARTO-Finder-guided ablation plus pulmonary vein isolation versus multiscale entropy (MSE)-guided pulmonary vein isolation in patients with persistent atrial fibrillation.
Detailed description
This is a randomized control trial. Patients with persistent atrial fibrillation are enrolled and randomized to CARTO-Finder-guided ablation plus PVI group or MSE-guided ablation plus PVI group. Postoperative recurrence rate and other indicators are analyzed to compare the efficacy and safety between CARTO-Finder-guided ablation plus PVI and MSE-guided ablation plus PVI in patients with persistent atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CARTO-Finder-guided ablation plus PVI | Active comparator | Procedure: CARTO-Finder-guided ablation plus PVIPulmonary vein circumferential isolation + + ablation of sites recognized by CARTO-Finder module as the core of rotors. |
| Multiscale entropy-guided ablation plus PVI | Experimental | Procedure: Multiscale entropy-guided ablation plus PVIPulmonary vein circumferential isolation + ablation of sites recognized by multiscale entropy analysis as the core of rotors. |
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 (11 listed)
- With uncontrolled congestive heart failure;
- Having significant valvular disease;
- Having moderate-to-severe pulmonary hypertension;
- With myocardial infarction or stroke within 6 months of screening;
- With Significant congenital heart disease;
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 |
|---|---|---|
| Multiscale entropy-guided ablation plus PVIThe multiscale entropy is calculated based on intracardiac electrical signals, higher multiscale entropy value indicates closer to the core of rotors which maintains the persistent atrial fibrillation. | Procedure or surgery | Multiscale entropy-guided ablation plus PVI |
| CARTO-Finder-guided ablation plus PVICARTO-Finder-guided ablation plus PVI | Procedure or surgery | CARTO-Finder-guided ablation plus PVI |
Primary outcome
Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate
Time frame: up to 24 months after enrollment
AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration
2 secondary outcomes
Postoperative AF recurrence rate
Time frame: up to 24 months after enrollment
Postoperative AFL/AT rate
Time frame: up to 24 months after enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiscale entropy-guided ablation plus PVI and CARTO-Finder-guided ablation plus PVI in people with Persistent Atrial Fibrillation, 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 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 12 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?
Contact Xu Liu, M.D. (18017321689, heartlx@sina.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 24 months after enrollment). 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 12 Jul 2022.