Atrial Fibrillation RecurrentILVRA-PAFM-UAHNCT06694610
A Study on the Relationship Between Individualized Low Voltage Regions in Left Atrium and the Mechanism of Atrial Fibrillation in Persistent Atrial Fibrillation Under Ultra-High-Resolution Mapping
A study testing non-pulmonary vein ablation group and only pulmonary vein ablation group in people with Atrial Fibrillation Recurrent, run by The Third People's Hospital of Chengdu.
Trial summary
The latest OCTARAY multi-electrode mapping catheter and TUREref technology were used to perform ultra-high precision mapping on the left atrial and left atrial auricle of persistent atrial fibrillation in the condition of sinus rhythm and atrial fibrillation respectively, and the density and accuracy of potential were… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Atrial Fibrillation Recurrent
- What is being tested?
- non-pulmonary vein ablation group and only pulmonary vein ablation group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2024to 5 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 85 years;
- Diagnosed with drug-refractory, symptomatic, persistent atrial fibrillation; Definition: At least one electrocardiogram (ECG) record of an atrial fibrillation episode within 12 months prior to enrollment.
- Non-valvular atrial fibrillation;
- Able to understand the purpose of the study, voluntarily participate in the study, the patient or their legal representative signs the informed consent form, and willing to complete follow-ups as required by the study protocol.-
Who cannot join
- Atrial fibrillation secondary to thyroid disease or other reversible factors;
- Imaging studies indicating intracardiac thrombus;
- Moderate to severe mitral stenosis or regurgitation;
- Left ventricular ejection fraction <40%, or New York Heart Association (NYHA) functional class III or IV;
- Unstable angina;
- Myocardial infarction (MI) or coronary artery bypass grafting (CABG) within 3 months prior to enrollment;
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- Presence of mural thrombus, space-occupying disease, or other abnormalities that hinder vascular puncture or catheter manipulation;
- Contraindications to anticoagulation and a history of blood coagulation or bleeding abnormalities;
- Patients with active systemic infections; Patients who have had an atrial septal closure device implanted within the last 6 weeks;
- Female patients who are pregnant, breastfeeding, or unable to use contraception during the study period;
- Patients with a life expectancy of less than 12 months (e.g., advanced malignant tumors); patients who have had an atrial septal closure device implanted within the last 6 weeks;
- Conditions affecting vascular access;
- Patients who are concurrently participating in other drug or device clinical trials;
- Any other abnormalities or diseases that the investigator deems should exclude the patient from the study enrollment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The latest OCTARAY multi-electrode mapping catheter and TUREref technology were used to perform ultra-high precision mapping on the left atrial and left atrial auricle of persistent atrial fibrillation in the condition of sinus rhythm and atrial fibrillation respectively, and the density and accuracy of potential were significantly improved. According to the mapping results, the numerical calculation of the personalized low voltage region was carried out, and the personalized ablation route was designed according to the low voltage region.
Read the detailed description
- The latest OCTARAY multi-electrode mapping catheter and TUREref technology were used to perform ultra-high precision mapping on the left atrial and left atrial auricle of persistent atrial fibrillation in the condition of sinus rhythm and atrial fibrillation respectively, and the density and accuracy of potential were significantly improved. According to the mapping results, the numerical calculation of the personalized low voltage region was carried out, and the personalized ablation route was designed according to the low voltage region.
- Octaray multi-electrode mapping catheter and CartoFinder software were used to map focal drive and reentrant ring in left atrial fibrillation. Based on the CartoFinder software's mapping of focal drive and normal potential areas, potential analysis was used to find the reentrant ring of persistent AF. The ablation route of the reentry ring is designed.
- Based on the designed ablation route, it is divided into different ablation route groups. They were divided into two groups: treatment of pulmonary vein ablation route only; Treatment of non-pulmonary venous ablation route group. In the group treated with only pulmonary vein ablation route, only potential isolation of pulmonary vein was performed, and bidirectional block was the end point. In the non-pulmonary vein ablation group, pulmonary vein isolation was not allowed, but the left atrial low-voltage area was treated first, and then the ablation route that terminated the reentry ring was treated. In the low-voltage region ablation group, if there was a large difference between the low-voltage region in atrial fibrillation and the low-voltage region in sinusional state, there was a common low-voltage region and a non-common low-voltage region. The non-common low-voltage region refers to the region with low voltage region in atrial fibrillation and no low voltage region in sinusional state. This type of cases were divided into two subgroups, A and B. Group A preferentially ablated the non-common low voltage region, group B preferentially ablated the common low voltage region. In the condition of atrial fibrillation, if there is overlap between the low-voltage ablation line and the reentrant ablation line in the non-pulmonary vein ablation group, the overlap line should be abated preferentially.
- In each group, the atrial fibrillation was attributed to the maintenance factor group according to the region of transsinus ablation or the region of atrial flutter tachycardia ablation. Pulmonary vene-associated atrial fibrillation, low-voltage region associated atrial fibrillation, reentrant ring associated atrial fibrillation.
- The intraoperative ablation data of each group were analyzed, such as ablation number, time, stopping site, and follow-up sinus rhythm maintenance rate. "Follow-up times are at 3 months, 6 months, and 12 months post-surgery. "Monitoring heart rhythm through the use of 7-day ambulatory Holter monitoring."
- Conditions
- Atrial Fibrillation Recurrent
- Being tested
- non-pulmonary vein ablation group, only pulmonary vein ablation group
- Keywords
- 心房颤动（Atrial Fibrillation）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-pulmonary vein ablation groupProcedure or surgery
In the non-pulmonary vein ablation group, pulmonary vein isolation was not allowed, but the left atrial low-voltage area was treated first, and then the ablation route that terminated the reentry ring was treated.
only pulmonary vein ablation groupProcedure or surgery
In the group treated with only pulmonary vein ablation route, only potential isolation of pulmonary vein was performed, and bidirectional block was the end point.
| Study group | Role | What they receive |
|---|---|---|
| non-pulmonary vein ablation group | Experimental | In the non-pulmonary vein ablation group, pulmonary vein isolation was not allowed, but the left atrial low-voltage area was treated first, and then the ablation route that terminated the reentry ring was treated. Receives: Procedure: non-pulmonary vein ablation group |
| only pulmonary vein ablation group | Active comparator | In the group treated with only pulmonary vein ablation route, only potential isolation of pulmonary vein was performed, and bidirectional block was the end point. Receives: Procedure: only pulmonary vein ablation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate Atrial Fibrillation Termination Rate
The number of atrial fibrillation rhythms ablated to sinus rhythm or flutter/atrial tachycardia during the procedure.
Measured: Intraoperative Immediate
Secondary outcomes (1)
Ablation Success Rate at 12 Months Post-Operation.
No electrocardiogram (ECG) recordings of atrial fibrillation, flutter, or tachycardia lasting ≥30 seconds from the end of the blanking period to the end of the 12-month follow-up.
Measured: 12 Months Post-Operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start15 Nov 2024 (estimated)
- Primary completion5 Apr 2025 (estimated)
- Study completion5 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation RecurrentStudies 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
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third People's Hospital of Chengdu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanxiong Liu, The Third People's Hospital of Chengdu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06694610
- Sponsor's protocol ID
- CDSY-ILVRA-PAFM-UAH
- Acronym
- ILVRA-PAFM-UAH
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 19 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Relationship Between Individualized Low Voltage Regions in Left Atrium and the Mechanism of Atrial Fibrillation in Persistent Atrial Fibrillation Under Ultra-High-Resolution Mapping
- ClinicalTrials.gov ID
- NCT06694610
- Acronym / sponsor ID
- ILVRA-PAFM-UAH / CDSY-ILVRA-PAFM-UAH
- Conditions
- Atrial Fibrillation Recurrent
- Keywords
- 心房颤动（Atrial Fibrillation）
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The Third People's Hospital of ChengduUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 5 Apr 2025 (estimated)
- Study completion
- 5 Apr 2026 (estimated)
- First posted
- 19 Nov 2024 (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.
The latest OCTARAY multi-electrode mapping catheter and TUREref technology were used to perform ultra-high precision mapping on the left atrial and left atrial auricle of persistent atrial fibrillation in the condition of sinus rhythm and atrial fibrillation respectively, and the density and accuracy of potential were significantly improved. According to the mapping results, the numerical calculation of the personalized low voltage region was carried out, and the personalized ablation route was designed according to the low voltage region.
Detailed description
- The latest OCTARAY multi-electrode mapping catheter and TUREref technology were used to perform ultra-high precision mapping on the left atrial and left atrial auricle of persistent atrial fibrillation in the condition of sinus rhythm and atrial fibrillation respectively, and the density and accuracy of potential were significantly improved. According to the mapping results, the numerical calculation of the personalized low voltage region was carried out, and the personalized ablation route was designed according to the low voltage region.
- Octaray multi-electrode mapping catheter and CartoFinder software were used to map focal drive and reentrant ring in left atrial fibrillation. Based on the CartoFinder software's mapping of focal drive and normal potential areas, potential analysis was used to find the reentrant ring of persistent AF. The ablation route of the reentry ring is designed.
- Based on the designed ablation route, it is divided into different ablation route groups. They were divided into two groups: treatment of pulmonary vein ablation route only; Treatment of non-pulmonary venous ablation route group. In the group treated with only pulmonary vein ablation route, only potential isolation of pulmonary vein was performed, and bidirectional block was the end point. In the non-pulmonary vein ablation group, pulmonary vein isolation was not allowed, but the left atrial low-voltage area was treated first, and then the ablation route that terminated the reentry ring was treated. In the low-voltage region ablation group, if there was a large difference between the low-voltage region in atrial fibrillation and the low-voltage region in sinusional state, there was a common low-voltage region and a non-common low-voltage region. The non-common low-voltage region refers to the region with low voltage region in atrial fibrillation and no low voltage region in sinusional state. This type of cases were divided into two subgroups, A and B. Group A preferentially ablated the non-common low voltage region, group B preferentially ablated the common low voltage region. In the condition of atrial fibrillation, if there is overlap between the low-voltage ablation line and the reentrant ablation line in the non-pulmonary vein ablation group, the overlap line should be abated preferentially.
- In each group, the atrial fibrillation was attributed to the maintenance factor group according to the region of transsinus ablation or the region of atrial flutter tachycardia ablation. Pulmonary vene-associated atrial fibrillation, low-voltage region associated atrial fibrillation, reentrant ring associated atrial fibrillation.
- The intraoperative ablation data of each group were analyzed, such as ablation number, time, stopping site, and follow-up sinus rhythm maintenance rate. "Follow-up times are at 3 months, 6 months, and 12 months post-surgery. "Monitoring heart rhythm through the use of 7-day ambulatory Holter monitoring."
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-pulmonary vein ablation group | Experimental | Procedure: non-pulmonary vein ablation groupIn the non-pulmonary vein ablation group, pulmonary vein isolation was not allowed, but the left atrial low-voltage area was treated first, and then the ablation route that terminated the reentry ring was treated. |
| only pulmonary vein ablation group | Active comparator | Procedure: only pulmonary vein ablation groupIn the group treated with only pulmonary vein ablation route, only potential isolation of pulmonary vein was performed, and bidirectional block was the end point. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 to 85 years;
- Diagnosed with drug-refractory, symptomatic, persistent atrial fibrillation; Definition: At least one electrocardiogram (ECG) record of an atrial fibrillation episode within 12 months prior to enrollment.
- Non-valvular atrial fibrillation;
- Able to understand the purpose of the study, voluntarily participate in the study, the patient or their legal representative signs the informed consent form, and willing to complete follow-ups as required by the study protocol.-
Key exclusion criteria (14 listed)
- Atrial fibrillation secondary to thyroid disease or other reversible factors;
- Imaging studies indicating intracardiac thrombus;
- Moderate to severe mitral stenosis or regurgitation;
- Left ventricular ejection fraction <40%, or New York Heart Association (NYHA) functional class III or IV;
- Unstable angina;
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 |
|---|---|---|
| non-pulmonary vein ablation groupIn the non-pulmonary vein ablation group, pulmonary vein isolation was not allowed, but the left atrial low-voltage area was treated first, and then the ablation route that terminated the reentry ring was treated. | Procedure or surgery | non-pulmonary vein ablation group |
| only pulmonary vein ablation groupIn the group treated with only pulmonary vein ablation route, only potential isolation of pulmonary vein was performed, and bidirectional block was the end point. | Procedure or surgery | only pulmonary vein ablation group |
Primary outcome
Immediate Atrial Fibrillation Termination Rate
Time frame: Intraoperative Immediate
The number of atrial fibrillation rhythms ablated to sinus rhythm or flutter/atrial tachycardia during the procedure.
1 secondary outcome
Ablation Success Rate at 12 Months Post-Operation.
Time frame: 12 Months Post-Operation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing non-pulmonary vein ablation group and only pulmonary vein ablation group in people with Atrial Fibrillation Recurrent, run by The Third People's Hospital of Chengdu.
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 14 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: opening soon, as of the sponsor's last update on 19 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Prof.Liu (8613551044286, lhanx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate Atrial Fibrillation Termination Rate (time frame: Intraoperative Immediate). 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 19 Nov 2024.