Persistent Atrial FibrillationNCT05652517
Univu-guided Vein of Marshall Ethanol Infusion (Marshall-Merge)
A study testing Vein of Marshall ethanol infusion in people with Persistent Atrial Fibrillation and Longstanding Persistent Atrial Fibrillation, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The study is a prospective, randomized, single-blind clinical trial aiming to compare two method in guidance of Vein of Marshall ethanol infusion (VOMEI), i.e., the conventional fluoroscopy-guided VOMEI and UNIVU-guided VOMEI. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Persistent Atrial Fibrillation, Longstanding Persistent Atrial Fibrillation
- What is being tested?
- 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
- 100 participants
- Where
- 1 siteChina
- Study dates
- Dec 2022to 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 85 years
- Sympathetic atrial fibrillation without previous ablation
- Persistent or long-standing persistent AF
- Patients' willing to undergo catheter ablation and VOMEI
Who cannot join
- Left atrial or left atrial appendage thrombus
- LVEF <30%
- Cardiac surgery within 90 days
- Myocardial infarction within 90 days
- PCI or PTCA within 90 days
- Thromboembolic events within 90 days, including stroke, pulmonary embolism, systemic embolism
Show all 19Show fewer
- Atrial myxoma
- Congenital heart disease
- Pregnant or pregnant plan
- Acute or severe infection
- Creatine> 221 μmol/L, or GFR <30 ml/min/1.73 m.
- Unstable angina
- Blood-clotting or bleeding disorder
- Contraindication to anticoagulation
- Life expectancy less than 1 year
- Uncontrolled heart failure
- Uncontrolled malignant tumor
- Malformation of femoral vascular access
- Without consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xinhua hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, 200092
Jian Sun, sunjian@xinhuamed.com.cn
About this study
Official title: Image Fusion of Integrating Fluoroscopy Into 3D Computed Tomography in Guidance of Vein of Marshall Ethanol Infusion During Persistent Atrial Fibrillation Ablation
The study is a prospective, randomized, single-blind clinical trial aiming to compare two method in guidance of Vein of Marshall ethanol infusion (VOMEI), i.e., the conventional fluoroscopy-guided VOMEI and UNIVU-guided VOMEI.
Read the detailed description
A total of 100 participants with persistent or longstanding persistent AF who undergo radiofrequency catheter ablation will be randomized assigned to two groups at 1:1 ratio to receive Vein of Marshall ethanol infusion (VOMEI).
Group 1: VOMEI guided by fluroscopy alone Group 2: VOMEI guided by fluoroscopy and CARTO UNIVU The intraprocedural major endpoints are the change in low-voltage area led by VOMEI (efficacy endpoint) and procedural complications (safety endpoint). The longterm major endpoint is the recurrence of atrial tachyarrhythmia between 3 and 12 months.
- Being tested
- Vein of Marshall ethanol infusion
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vein of Marshall ethanol infusionProcedure or surgery
Vein of Marshall ethanol infusion performed during the radiofrequency catheter ablation of persistent or long-standing persistent atrial fibrillation.
| Study group | Role | What they receive |
|---|---|---|
| Fluoroscopy-guided VOMEI | Active comparator | Vein of Marshall ethanol infusion guided by fluoroscopy alone Receives: Procedure: Vein of Marshall ethanol infusion |
| UNIVU-guided VOMEI | Experimental | Vein of Marshall ethanol infusion guided by CARTO UNIVU and fluoroscopy Receives: Procedure: Vein of Marshall ethanol infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of low-voltage or scar area before and after VOMEI
Left atrial voltage mapping will be performed before and after VOMEI. The low-voltage area or scar area will be mesured and compared before and after VOMEI
Measured: During the procedure
Procedural complications
Including cardiac tamponade, stroke, systemic embolism, major bleeding, acute coronary syndrome, acute heart failure, and death.
Measured: within 72 hours
Recurrence of atrial tachyarrhythmias
Including recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia
Measured: 3 to 12 months
Secondary outcomes (10)
Rates of mitral isthmus block
bidirectional block of mitral isthmus
Measured: During the procedure
New low-voltage or scar area outside mitral isthmus and left pulmonary ridge
New low-voltage or scar area after VOMEI outside the targeted regions
Measured: During the procedure
Rates of VOMEI incomplete
Any reason leading to incomplete VOMEI
Measured: During the procedure
X ray exposure time
Procedure-related temporal parameters
Measured: During the procedure
procedure time
Procedure-related temporal parameters
Measured: During the procedure
radiofrequency ablation time
Procedure-related temporal parameters
Measured: During the procedure
Rates of intraprocedural termination of atrial fibrillation (not achieved by cardioversion)
Termination of atrial fibrillation without cardioversion
Measured: During the procedure
Burden of atrial tachyarrhythmia
Evaluation by Holder monitoring at 12 months
Measured: 12 months
Recurrence of atrial flutter
recurrence of atrial flutter > 30 second by ECG or Holder monitoring
Measured: 3 to 12 months
Volume of ethanol and contrast agent used
ethanol volume, contrast agent volume used during the procedure
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study startDec 2022 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 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 Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Sun, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Jian Sun, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05652517
- Sponsor's protocol ID
- XH-22-009
- Status last verified
- Dec 2022
- First submitted
- 28 Nov 2022
- Last updated
- 15 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Fusion of Integrating Fluoroscopy Into 3D Computed Tomography in Guidance of Vein of Marshall Ethanol Infusion During Persistent Atrial Fibrillation Ablation
- ClinicalTrials.gov ID
- NCT05652517
- Acronym / sponsor ID
- XH-22-009
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 Dec 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.
The study is a prospective, randomized, single-blind clinical trial aiming to compare two method in guidance of Vein of Marshall ethanol infusion (VOMEI), i.e., the conventional fluoroscopy-guided VOMEI and UNIVU-guided VOMEI.
Detailed description
A total of 100 participants with persistent or longstanding persistent AF who undergo radiofrequency catheter ablation will be randomized assigned to two groups at 1:1 ratio to receive Vein of Marshall ethanol infusion (VOMEI).
Group 1: VOMEI guided by fluroscopy alone Group 2: VOMEI guided by fluoroscopy and CARTO UNIVU The intraprocedural major endpoints are the change in low-voltage area led by VOMEI (efficacy endpoint) and procedural complications (safety endpoint). The longterm major endpoint is the recurrence of atrial tachyarrhythmia between 3 and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluoroscopy-guided VOMEI | Active comparator | Procedure: Vein of Marshall ethanol infusionVein of Marshall ethanol infusion guided by fluoroscopy alone |
| UNIVU-guided VOMEI | Experimental | Procedure: Vein of Marshall ethanol infusionVein of Marshall ethanol infusion guided by CARTO UNIVU and fluoroscopy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 85 years
- Sympathetic atrial fibrillation without previous ablation
- Persistent or long-standing persistent AF
- Patients' willing to undergo catheter ablation and VOMEI
Key exclusion criteria (19 listed)
- Left atrial or left atrial appendage thrombus
- LVEF <30%
- Cardiac surgery within 90 days
- Myocardial infarction within 90 days
- PCI or PTCA within 90 days
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 |
|---|---|---|
| Vein of Marshall ethanol infusionVein of Marshall ethanol infusion performed during the radiofrequency catheter ablation of persistent or long-standing persistent atrial fibrillation. | Procedure or surgery | Fluoroscopy-guided VOMEI, UNIVU-guided VOMEI |
Primary outcome
Changes of low-voltage or scar area before and after VOMEI
Time frame: During the procedure
Left atrial voltage mapping will be performed before and after VOMEI. The low-voltage area or scar area will be mesured and compared before and after VOMEI
Procedural complications
Time frame: within 72 hours
Including cardiac tamponade, stroke, systemic embolism, major bleeding, acute coronary syndrome, acute heart failure, and death.
Recurrence of atrial tachyarrhythmias
Time frame: 3 to 12 months
Including recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia
10 secondary outcomes
Rates of mitral isthmus block
Time frame: During the procedure
New low-voltage or scar area outside mitral isthmus and left pulmonary ridge
Time frame: During the procedure
Rates of VOMEI incomplete
Time frame: During the procedure
X ray exposure time
Time frame: During the procedure
procedure time
Time frame: During the procedure
radiofrequency ablation time
Time frame: During the procedure
Rates of intraprocedural termination of atrial fibrillation (not achieved by cardioversion)
Time frame: During the procedure
Burden of atrial tachyarrhythmia
Time frame: 12 months
Recurrence of atrial flutter
Time frame: 3 to 12 months
Volume of ethanol and contrast agent used
Time frame: During the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2022.
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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.
Jian Sun principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vein of Marshall ethanol infusion in people with Persistent Atrial Fibrillation and Longstanding Persistent Atrial Fibrillation, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 4 inclusion and 19 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 15 Dec 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 Mu Chen, MD (021-25077287, chenmu@xinhuamed.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of low-voltage or scar area before and after VOMEI (time frame: During the procedure). The study lists 3 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 15 Dec 2022; AzTrials last refreshed its copy on 8 Nov 2026.