Atrial FibrillationHOTNCT03998956
High-density Mapping-guided bOx Isolation and subsTrate Ablation
A study testing CPVI, CPVI+BOX and CPVI+BOX+SUB in people with Atrial Fibrillation and Atrial Remodeling, run by The Third Xiangya Hospital of Central South University.
Trial summary
This study evaluates the efficacy of high-density mapping guided atrial substrate ablation for persistent atrial fibrillation. 1/5 of the patients with persistent atrial fibrillation undergo pulmonary veins isolation, 2/5 of them pulmonary veins and box isolation while others undergo atrial substrate ablation apart… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atrial Fibrillation, Atrial Remodeling
- What is being tested?
- CPVI, CPVI+BOX and CPVI+BOX+SUB
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2019to 31 Aug 2021
- 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
- Informed consent signed.
- Age of 18 to 75 years old.
- Persistent or longstanding persistent atrial fibrillation (≥7 days), which is confirmed by Holter in recent six months.
- Willing to have catheter ablation for atrial fibrillation.
Who cannot join
- Accompanied by serious heart diseases including cardiac valvular diseases, congenital heart diseases, hypertrophic obstructive cardiomyopathy, acute myocardium infarction, unstable anginal pectoris and so on.
- Complete atrioventricular block.
- An acute stroke or contradiction of anti-coagulation.
- Hyperthyroidism.
- Having a history of catheter ablation of atrial fibrillation.
- Left atrial appendage thrombosis confirmed by transesophageal echocardiography.
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- Pregnancy or lactation.
- Planning for pregnancy in the near future.
- Myopathy or active liver disease, including patients with sustained increase of serum transaminase of unknown reason and the ones with increased serum transaminase over three times the upper limit of normal.
- Patients of severe renal insufficiency with creatinine clearance lower than 30 ml/min.
About this study
Official title: Study of High-density Mapping-guided bOx Isolation and subsTrate Ablation for Persistent Atrial Fibrillation
This study evaluates the efficacy of high-density mapping guided atrial substrate ablation for persistent atrial fibrillation. 1/5 of the patients with persistent atrial fibrillation undergo pulmonary veins isolation, 2/5 of them pulmonary veins and box isolation while others undergo atrial substrate ablation apart from pulmonary veins and box isolation.
- Conditions
- Atrial Fibrillation, Atrial Remodeling
- Being tested
- CPVI, CPVI+BOX, CPVI+BOX+SUB
- Keywords
- catheter ablation
- Medical subject headings
- Atrial Fibrillation, Atrial Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPVIProcedure or surgery
Circumferential PV isolation only
CPVI+BOXProcedure or surgery
Circumferential PV and BOX isolation
CPVI+BOX+SUBProcedure or surgery
Atrial substrate ablation apart from circumferential PV and BOX isolation
| Study group | Role | What they receive |
|---|---|---|
| Circumferential PV isolation | Active comparator | Circumferential PV isolation only Receives: Procedure: CPVI |
| Circumferential PV and BOX isolation | Experimental | Circumferential PV and BOX isolation Receives: Procedure: CPVI+BOX |
| circumferential PV and BOX isolation with substrate ablation | Experimental | Atrial substrate ablation apart from circumferential PV and BOX isolation Receives: Procedure: CPVI+BOX+SUB |
What is being measured
The primary outcome is the main question the study is designed to answer.
sinus rhythm maintenance rate
Holter is performed 12months after the procedure and heart rhythm is recorded.
Measured: 12 months
Secondary outcomes (3)
left ventricular ejection fraction
LVEF is evaluated by echocardiography 12months after the procedure.
Measured: 12 months
Stroke or embolic events
History of stroke or embolic events is taken at each follow-up during the period of 12 months after procedure, and if necessary, radiographic examinations will be performed.
Measured: 12 months
Atrial fibrosis
Atrial substrate mapping is performed before and after catheter ablation in one day to evaluate the atrial fibrosis.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2019
- Study start1 Aug 2019 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2021 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03998956
- Sponsor's protocol ID
- 3rdxiangya@csu
- Acronym
- HOT
- Status last verified
- Jun 2019
- First submitted
- 25 Jun 2019
- Last updated
- 1 Jul 2019
- 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 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of High-density Mapping-guided bOx Isolation and subsTrate Ablation for Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03998956
- Acronym / sponsor ID
- HOT / 3rdxiangya@csu
- Conditions
- Atrial Fibrillation, Atrial Remodeling
- Keywords
- catheter ablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 26 Jun 2019 (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 study evaluates the efficacy of high-density mapping guided atrial substrate ablation for persistent atrial fibrillation. 1/5 of the patients with persistent atrial fibrillation undergo pulmonary veins isolation, 2/5 of them pulmonary veins and box isolation while others undergo atrial substrate ablation apart from pulmonary veins and box isolation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Circumferential PV isolation | Active comparator | Procedure: CPVICircumferential PV isolation only |
| Circumferential PV and BOX isolation | Experimental | Procedure: CPVI+BOXCircumferential PV and BOX isolation |
| circumferential PV and BOX isolation with substrate ablation | Experimental | Procedure: CPVI+BOX+SUBAtrial substrate ablation apart from circumferential PV and BOX isolation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent signed.
- Age of 18 to 75 years old.
- Persistent or longstanding persistent atrial fibrillation (≥7 days), which is confirmed by Holter in recent six months.
- Willing to have catheter ablation for atrial fibrillation.
Key exclusion criteria (10 listed)
- Accompanied by serious heart diseases including cardiac valvular diseases, congenital heart diseases, hypertrophic obstructive cardiomyopathy, acute myocardium infarction, unstable anginal pectoris and so on.
- Complete atrioventricular block.
- An acute stroke or contradiction of anti-coagulation.
- Hyperthyroidism.
- Having a history of catheter ablation of atrial fibrillation.
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 |
|---|---|---|
| CPVICircumferential PV isolation only | Procedure or surgery | Circumferential PV isolation |
| CPVI+BOXCircumferential PV and BOX isolation | Procedure or surgery | Circumferential PV and BOX isolation |
| CPVI+BOX+SUBAtrial substrate ablation apart from circumferential PV and BOX isolation | Procedure or surgery | circumferential PV and BOX isolation with substrate ablation |
Primary outcome
sinus rhythm maintenance rate
Time frame: 12 months
Holter is performed 12months after the procedure and heart rhythm is recorded.
3 secondary outcomes
left ventricular ejection fraction
Time frame: 12 months
Stroke or embolic events
Time frame: 12 months
Atrial fibrosis
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing CPVI, CPVI+BOX and CPVI+BOX+SUB in people with Atrial Fibrillation and Atrial Remodeling, run by The Third Xiangya Hospital of Central South University.
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 4 inclusion and 10 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 1 Jul 2019. 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?
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?
sinus rhythm maintenance rate (time frame: 12 months). 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 1 Jul 2019; AzTrials last refreshed its copy on 26 Oct 2026.