Atrial Fibrillation, PersistentNCT06578793
Comparison of Catheter Plus Marshall Vein Ablation vs. Catheter Ablation Alone in Persistent AF With Heart Failure
A study testing Catheter Ablation Combined with Marshall Vein Ethanol Ablation in people with Atrial Fibrillation, Persistent and Heart Failure, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This multicenter, randomized controlled trial aims to compare the clinical efficacy and safety of combining catheter ablation with Marshall vein ethanol ablation versus catheter ablation alone in patients with persistent atrial fibrillation (AF) and concomitant heart failure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Persistent, Heart Failure
- What is being tested?
- Catheter Ablation Combined with Marshall Vein Ethanol Ablation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 31 Jan 2026
- 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
- Age between 18 and 80 years
- For symptomatic patients with persistent atrial fibrillation: At least a 6-month history of atrial fibrillation; atrial fibrillation duration exceeding 7 days without spontaneous conversion to sinus rhythm; at least two episodes of persistent atrial fibrillation in the past 6 months even after rhythm conversion; poor tolerance or resistance to at least one Class I, II, or III antiarrhythmic drug
- Diagnosed with heart failure: Echocardiogram showing left ventricular ejection fraction (LVEF) ≤40%
- Patient willing to receive medication or surgical treatment
- Patient willing to comply with the requirements before the study, during the study, and during follow-up and to sign an informed consent form
- Capable of completing a 6-minute walk test
- For women of childbearing potential, a negative pregnancy test result is required
Who cannot join
- Presence of thrombus in the left atrium
- Left atrial diameter greater than 65 millimeters in the parasternal long-axis view, or left atrial volume exceeding 200 milliliters as measured by MRI or CT
- Presence of significant congenital abnormalities or medical issues, deemed by the researcher as inappropriate for participation in the study
- Reversible causes of atrial fibrillation, such as pericarditis, thyroid disease, acute alcohol intoxication, recent major surgery, or trauma
- Currently suffering from valvular heart disease requiring surgical intervention
- Currently suffering from coronary artery disease requiring surgical or percutaneous intervention
Show all 15Show fewer
- History of atrioventricular node ablation
- Liver failure
- Renal failure requiring dialysis
- Contraindicated use of appropriate anticoagulation therapy
- Participation in other experimental drug or device studies
- Severe pulmonary disease
- Previous catheter ablation for atrial fibrillation in the left atrium
- Documented thromboembolic event within the past 90 days
- Pregnant women
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Li Xuping, PhD, 13973183686, lixp0711@126.com
Liu Zhenjiang, PhD
About this study
Official title: Comparison of Catheter Ablation Combined With Ethanol Ablation of the Marshall Vein vs. Catheter Ablation Alone in Persistent Atrial Fibrillation With Heart Failure: A Multicenter Randomized Controlled Study
This multicenter, randomized controlled trial aims to compare the clinical efficacy and safety of combining catheter ablation with Marshall vein ethanol ablation versus catheter ablation alone in patients with persistent atrial fibrillation (AF) and concomitant heart failure. Persistent AF is a common arrhythmia that significantly impacts the quality of life and survival rates, especially when coexisting with heart failure. While catheter ablation is a standard treatment for AF, its effectiveness in persistent AF, particularly in patients with heart failure, remains suboptimal. The addition of Marshall vein ethanol ablation may enhance treatment outcomes by targeting arrhythmogenic substrates. This study will enroll 120 participants across three centers to evaluate whether this combined approach can reduce AF recurrence, improve heart function, and enhance patient outcomes compared to catheter ablation alone.
Read the detailed description
Persistent atrial fibrillation (AF) combined with heart failure presents a significant clinical challenge due to the high rates of morbidity and mortality associated with these conditions. Catheter ablation is widely used to manage AF, but its efficacy in persistent AF, particularly in patients with heart failure, is limited. Recent advances suggest that targeting the Marshall vein with ethanol ablation may offer additional benefits by disrupting critical pathways involved in AF maintenance.
This study is designed to evaluate the efficacy of combining Marshall vein ethanol ablation with standard catheter ablation compared to catheter ablation alone in a well-defined patient population. Conducted across three centers, this randomized controlled trial will rigorously assess whether the combined approach can offer superior outcomes, including lower AF recurrence rates and improved heart function. The study's findings are expected to contribute valuable insights into optimizing treatment strategies for this high-risk patient group.
- Conditions
- Atrial Fibrillation, Persistent, Heart Failure
- Being tested
- Catheter Ablation Combined with Marshall Vein Ethanol Ablation
- Keywords
- Atrial Fibrillation, Heart Failure, Catheter Ablation, Marshall Vein
- Medical subject headings
- Atrial Fibrillation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheter Ablation Combined with Marshall Vein Ethanol AblationProcedure or surgery
Also called Catheter Ablation Alone
This study involves two procedures. The first procedure is a combination of catheter ablation with ethanol ablation of the Marshall vein. The second procedure is catheter ablation alone. Both procedures involve standard techniques used to treat persistent atrial fibrillation, with the addition of Marshall vein ethanol ablation in the experimental group aimed at potentially improving outcomes by targeting additional arrhythmogenic substrates.
| Study group | Role | What they receive |
|---|---|---|
| Catheter ablation combined with Marshall vein ethanol ablation group | Experimental | Participants in this group will undergo standard catheter ablation, which involves the isolation of the pulmonary veins and may include additional ablation of other atrial areas as necessary, guided by fluoroscopy and/or 3D electroanatomical mapping. In addition to the standard ablation procedure, participants will receive Marshall vein ethanol ablation. This involves the injection of absolute ethanol into the Marshall vein via a specialized catheter, aiming to ablate the vein's myocardial sleeves and adjacent autonomic fibers. The ethanol ablation targets arrhythmogenic substrates and aims to enhance the efficacy of the overall ablation procedure by reducing atrial fibrillation triggers.
This combined approach is hypothesized to improve clinical outcomes by providing a more comprehensive treatment of atrial fibrillation substrates, particularly in patients with persistent atrial fibrillation and concomitant heart failure. Receives: Procedure: Catheter Ablation Combined with Marshall Vein Ethanol Ablation |
| Catheter ablation alone group | Active comparator | Participants in this group will undergo standard catheter ablation, which primarily involves the isolation of the pulmonary veins, a common trigger site for atrial fibrillation. The procedure may include additional ablation of other atrial areas based on the patient's specific arrhythmogenic substrate. The catheter ablation will be performed under fluoroscopic guidance and/or with the assistance of 3D electroanatomical mapping to ensure precision. This procedure is designed to eliminate or reduce the arrhythmogenic tissue within the atria to restore and maintain normal sinus rhythm.
This intervention is the comparator arm in the study, representing the current standard treatment for persistent atrial fibrillation, particularly in patients with concomitant heart failure. Receives: Procedure: Catheter Ablation Combined with Marshall Vein Ethanol Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from Atrial Fibrillation/Atrial Flutter (AT/AF) Recurrence
The primary outcome is the proportion of participants who remain free from clinical recurrence of atrial fibrillation (AF) or atrial flutter (AFL) at follow-up. Recurrence is defined as the absence of documented AF/AFL episodes lasting 30 seconds or more during continuous ECG monitoring over a 1-month period.
Measured: 12 months after the procedure
Change in NT-proBNP Levels
This outcome measures the change in NT-proBNP levels, a biomarker for heart failure, from baseline to follow-up, indicating the impact of the intervention on heart failure status.
Measured: 12 months after the procedure
Change in Left Ventricular Ejection Fraction (LVEF)
This outcome assesses the change in LVEF as measured by echocardiography, reflecting the effect of the intervention on cardiac function.
Measured: 12 months after the procedure
Change in 6-Minute Walk Test Distance
This outcome measures the change in the distance covered during the 6-minute walk test, an indicator of functional capacity and exercise tolerance.
Measured: 12 months after the procedure
Change in NYHA Functional Class
This outcome evaluates changes in the New York Heart Association (NYHA) functional classification, which assesses the severity of heart failure symptoms and functional limitations.
Measured: 12 months after the procedure
Secondary outcomes (11)
Presence or Absence of Arrhythmias Within 30 Days
This outcome measures whether arrhythmias related to the procedure occurred within 30 days post-intervention.
Measured: 30 days after the procedure
Presence or Absence of Chest Tightness Within 30 Days
This outcome measures whether chest tightness related to the procedure occurred within 30 days post-intervention.
Measured: 30 days after the procedure
Presence or Absence of Palpitations Within 30 Days
This outcome measures whether palpitations related to the procedure occurred within 30 days post-intervention.
Measured: 30 days after the procedure
Presence or Absence of Bleeding Within 30 Days
This outcome measures whether bleeding related to the procedure occurred within 30 days post-intervention.
Measured: 30 days after the procedure
Presence or Absence of Mortality Within 30 Days
This outcome measures whether mortality related to the procedure occurred within 30 days post-intervention.
Measured: 30 days after the procedure
Atrial Fibrillation Burden at 6 Months
This outcome assesses the percentage of time that patients experience atrial fibrillation (AF) during continuous monitoring 6 months post-intervention.
Measured: 6 months after the procedure
Atrial Fibrillation Burden at 12 Months
This outcome assesses the percentage of time that patients experience atrial fibrillation (AF) during continuous monitoring 12 months post-intervention.
Measured: 12 months after the procedure
Total Number of Procedures Performed
This outcome measures the total number of procedures performed during the intervention.
Measured: During the procedure(s)
Total Radiofrequency Ablation Time for the First Procedure
This outcome measures the total radiofrequency ablation time during the first procedure.
Measured: During the first procedure
Total Radiofrequency Ablation Time for the Second Procedure (if applicable)
This outcome measures the total radiofrequency ablation time during the second procedure, if applicable.
Measured: During the second procedure
Total Area of Left Atrial (LA) Tissue Ablated
This outcome measures the total area of left atrial (LA) tissue ablated during the procedure(s).
Measured: During the procedure(s)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Aug 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jan 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, PersistentStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Xuping, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06578793
- Sponsor's protocol ID
- XYSY_CAB_MVA_2024_001
- Status last verified
- Aug 2024
- First submitted
- 22 Aug 2024
- Last updated
- 29 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data (IPD) from this study with other researchers. The data will be used exclusively by the research team for the purposes of this study and will not be made available to third parties.
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Catheter Ablation Combined With Ethanol Ablation of the Marshall Vein vs. Catheter Ablation Alone in Persistent Atrial Fibrillation With Heart Failure: A Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06578793
- Acronym / sponsor ID
- XYSY_CAB_MVA_2024_001
- Conditions
- Atrial Fibrillation, Persistent, Heart Failure
- Keywords
- Atrial Fibrillation, Heart Failure, Catheter Ablation, Marshall Vein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 29 Aug 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.
This multicenter, randomized controlled trial aims to compare the clinical efficacy and safety of combining catheter ablation with Marshall vein ethanol ablation versus catheter ablation alone in patients with persistent atrial fibrillation (AF) and concomitant heart failure. Persistent AF is a common arrhythmia that significantly impacts the quality of life and survival rates, especially when coexisting with heart failure. While catheter ablation is a standard treatment for AF, its effectiveness in persistent AF, particularly in patients with heart failure, remains suboptimal. The addition of Marshall vein ethanol ablation may enhance treatment outcomes by targeting arrhythmogenic substrates. This study will enroll 120 participants across three centers to evaluate whether this combined approach can reduce AF recurrence, improve heart function, and enhance patient outcomes compared to catheter ablation alone.
Detailed description
Persistent atrial fibrillation (AF) combined with heart failure presents a significant clinical challenge due to the high rates of morbidity and mortality associated with these conditions. Catheter ablation is widely used to manage AF, but its efficacy in persistent AF, particularly in patients with heart failure, is limited. Recent advances suggest that targeting the Marshall vein with ethanol ablation may offer additional benefits by disrupting critical pathways involved in AF maintenance.
This study is designed to evaluate the efficacy of combining Marshall vein ethanol ablation with standard catheter ablation compared to catheter ablation alone in a well-defined patient population. Conducted across three centers, this randomized controlled trial will rigorously assess whether the combined approach can offer superior outcomes, including lower AF recurrence rates and improved heart function. The study's findings are expected to contribute valuable insights into optimizing treatment strategies for this high-risk patient group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Catheter ablation combined with Marshall vein ethanol ablation group | Experimental | Procedure: Catheter Ablation Combined with Marshall Vein Ethanol AblationParticipants in this group will undergo standard catheter ablation, which involves the isolation of the pulmonary veins and may include additional ablation of other atrial areas as necessary, guided by fluoroscopy and/or 3D electroanatomical mapping. In addition to the standard ablation procedure, participants will receive Marshall vein ethanol ablation. This involves the injection of absolute ethanol into the Marshall vein via a specialized catheter, aiming to ablate the vein's myocardial sleeves and adjacent autonomic fibers. The ethanol ablation targets arrhythmogenic substrates and aims to enhance the efficacy of the overall ablation procedure by reducing atrial fibrillation triggers. This combined approach is hypothesized to improve clinical outcomes by providing a more comprehensive treatment of atrial fibrillation substrates, particularly in patients with persistent atrial fibrillation and concomitant heart failure. |
| Catheter ablation alone group | Active comparator | Procedure: Catheter Ablation Combined with Marshall Vein Ethanol AblationParticipants in this group will undergo standard catheter ablation, which primarily involves the isolation of the pulmonary veins, a common trigger site for atrial fibrillation. The procedure may include additional ablation of other atrial areas based on the patient's specific arrhythmogenic substrate. The catheter ablation will be performed under fluoroscopic guidance and/or with the assistance of 3D electroanatomical mapping to ensure precision. This procedure is designed to eliminate or reduce the arrhythmogenic tissue within the atria to restore and maintain normal sinus rhythm. This intervention is the comparator arm in the study, representing the current standard treatment for persistent atrial fibrillation, particularly in patients with concomitant heart failure. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 18 and 80 years
- For symptomatic patients with persistent atrial fibrillation: At least a 6-month history of atrial fibrillation; atrial fibrillation duration exceeding 7 days without spontaneous conversion to sinus rhythm; at least two episodes of persistent atrial fibrillation in the past 6 months even after rhythm conversion; poor tolerance or resistance to at least one Class I, II, or III antiarrhythmic drug
- Diagnosed with heart failure: Echocardiogram showing left ventricular ejection fraction (LVEF) ≤40%
- Patient willing to receive medication or surgical treatment
- Patient willing to comply with the requirements before the study, during the study, and during follow-up and to sign an informed consent form
Key exclusion criteria (15 listed)
- Presence of thrombus in the left atrium
- Left atrial diameter greater than 65 millimeters in the parasternal long-axis view, or left atrial volume exceeding 200 milliliters as measured by MRI or CT
- Presence of significant congenital abnormalities or medical issues, deemed by the researcher as inappropriate for participation in the study
- Reversible causes of atrial fibrillation, such as pericarditis, thyroid disease, acute alcohol intoxication, recent major surgery, or trauma
- Currently suffering from valvular heart disease requiring surgical intervention
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 Ablation Combined with Marshall Vein Ethanol AblationAlso: Catheter Ablation AloneThis study involves two procedures. The first procedure is a combination of catheter ablation with ethanol ablation of the Marshall vein. The second procedure is catheter ablation alone. Both procedures involve standard techniques used to treat persistent atrial fibrillation, with the addition of Marshall vein ethanol ablation in the experimental group aimed at potentially improving outcomes by targeting additional arrhythmogenic substrates. | Procedure or surgery | Catheter ablation alone group, Catheter ablation combined with Marshall vein ethanol ablation group |
Primary outcome
Freedom from Atrial Fibrillation/Atrial Flutter (AT/AF) Recurrence
Time frame: 12 months after the procedure
The primary outcome is the proportion of participants who remain free from clinical recurrence of atrial fibrillation (AF) or atrial flutter (AFL) at follow-up. Recurrence is defined as the absence of documented AF/AFL episodes lasting 30 seconds or more during continuous ECG monitoring over a 1-month period.
Change in NT-proBNP Levels
Time frame: 12 months after the procedure
This outcome measures the change in NT-proBNP levels, a biomarker for heart failure, from baseline to follow-up, indicating the impact of the intervention on heart failure status.
Change in Left Ventricular Ejection Fraction (LVEF)
Time frame: 12 months after the procedure
This outcome assesses the change in LVEF as measured by echocardiography, reflecting the effect of the intervention on cardiac function.
Change in 6-Minute Walk Test Distance
Time frame: 12 months after the procedure
This outcome measures the change in the distance covered during the 6-minute walk test, an indicator of functional capacity and exercise tolerance.
Change in NYHA Functional Class
Time frame: 12 months after the procedure
This outcome evaluates changes in the New York Heart Association (NYHA) functional classification, which assesses the severity of heart failure symptoms and functional limitations.
11 secondary outcomes
Presence or Absence of Arrhythmias Within 30 Days
Time frame: 30 days after the procedure
Presence or Absence of Chest Tightness Within 30 Days
Time frame: 30 days after the procedure
Presence or Absence of Palpitations Within 30 Days
Time frame: 30 days after the procedure
Presence or Absence of Bleeding Within 30 Days
Time frame: 30 days after the procedure
Presence or Absence of Mortality Within 30 Days
Time frame: 30 days after the procedure
Atrial Fibrillation Burden at 6 Months
Time frame: 6 months after the procedure
Atrial Fibrillation Burden at 12 Months
Time frame: 12 months after the procedure
Total Number of Procedures Performed
Time frame: During the procedure(s)
Total Radiofrequency Ablation Time for the First Procedure
Time frame: During the first procedure
Total Radiofrequency Ablation Time for the Second Procedure (if applicable)
Time frame: During the second procedure
Total Area of Left Atrial (LA) Tissue Ablated
Time frame: During the procedure(s)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2024.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data (IPD) from this study with other researchers. The data will be used exclusively by the research team for the purposes of this study and will not be made available to third parties.
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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 Catheter Ablation Combined with Marshall Vein Ethanol Ablation in people with Atrial Fibrillation, Persistent and Heart Failure, run by Second Xiangya Hospital of Central South University 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 7 inclusion and 15 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 29 Aug 2024. 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 Li Xuping (3973183686, lixp0711@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from Atrial Fibrillation/Atrial Flutter (AT/AF) Recurrence (time frame: 12 months after the procedure). The study lists 5 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 29 Aug 2024.