Atrial FibrillationNCT06438692
Ablation Strategies for Persistent Atrial Fibrillation Combined With Heart Failure
A study testing VOM ethanol chemical ablation and 2C3L and 2C3L in people with Atrial Fibrillation and Heart Failure, run by Qianfoshan Hospital at 1 site in China.
Trial summary
(1) To evaluate the efficacy and safety of "2C3L" strategy combined with VOM anhydrous ethanol chemical ablation for persistent atrial fibrillation complicated with heart failure; (2) To evaluate the effectiveness of high-efficiency ablation of atrial fibrillation complicated with heart failure. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Atrial Fibrillation, Heart Failure
- What is being tested?
- VOM ethanol chemical ablation and 2C3L and 2C3L
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 16 Jun 2022to 16 Jun 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
- age:18y-80y
- First ablation on non valvular atrial fibrillation
- Persistent atrial fibrillation with LVEF≤40%
- The patient has symptoms related to atrial fibrillation, including but not limited to palpitations, premonitory syncope, syncope, fatigue, and shortness of breath, and is evaluated for clinical cardiac function between NYHA II-IV levels
- No response to antiarrhythmic drugs, unacceptable side effects, or unwillingness to take antiarrhythmic drugs.
Who cannot join
- Paroxysmal atrial fibrillation
- Atrial fibrillation secondary to obvious reversible causes
- Echocardiography: Parasternal long axis section, left atrial diameter ≥ 60mm
- LVEF >40%
- Receiving dual antithrombotic therapy
- Contraindications to the use of oral anticoagulants
Show all 10Show fewer
- Contraindications to right or left cardiac catheterization
- pregnancy
- Life expectancy<1 year (such as advanced malignant tumors, advanced kidney disease, etc.)
- Unable to discontinue antiarrhythmic drugs due to reasons other than atrial fibrillation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hesheng Hu
Jinan, Shandong, 250012
Hesheng Hu, 13589112300
About this study
Official title: Clinical Study on the 2C3L Strategy Based on Marshall Venous Chemoablation for the Treatment of Persistent Atrial Fibrillation Combined With Heart Failure
(1) To evaluate the efficacy and safety of "2C3L" strategy combined with VOM anhydrous ethanol chemical ablation for persistent atrial fibrillation complicated with heart failure; (2) To evaluate the effectiveness of high-efficiency ablation of atrial fibrillation complicated with heart failure.
Read the detailed description
2C3L ablation strategy: The electroanatomical mapping system was the Carto 3 V6 system of Johnson \& Johnson, and the high-density mapping electrode (Pentaray) and cold saline perfusion pressure catheter (ST-SF) were used for ablation. Ablation parameters were set as follows: ablation power of 45 to 50 Watts (reduced to 25 Watts in the coronary vein and 35 Watts in the endocardium of the mitral isthmus), upper temperature limit of 43 ° C, and saline infusion rate of 15 mL/ min (changed to 30 mL/min in coronary veins), the pressure was controlled at 5-15 g, and the target AI was set: 480-500 for the anterior wall of the pulmonary vein, 350-380 for the posterior wall, 450 for the top of the left atrium, 600 for the mitral valve isthmus, and 450 for the tricuspid valve isthmus. A single catheter procedure was performed in the left atrium, and the ablation endpoint was to achieve continuous bilateral circumferential pulmonary vein damage with loss of intrapulmonary vein potential, which was further confirmed after conversion to sinus rhythm. During left pulmonary vein ablation, the top and posterior wall of left pulmonary vein were ablated first. If pulmonary vein isolation was achieved, no further intervention was performed on the anterior edge of left pulmonary vein. The ablation of the mitral annulus started from about 1 cm away from the junction between the VOM and the coronary vein, and continued to the low-voltage area. Ablation was performed in the corresponding epicardium, namely the coronary vein. Finally, the isthmus of the tricuspid valve was ablated from 6:00 to the inferior vena cava. If the patient still had atrial fibrillation or atrial flutter after the above ablation, 200 J direct current was used to cardioversion the sinus rhythm, and the complete block of each ablation path was verified by pacing during sinus rhythm. In the ablation-only group, catheter ablation was used only to these end points. The operation time was from the start of venipuncture to the removal of sheath tube. The melting time was the cumulative ablation time.
VOM absolute ethanol chemical ablation: The SL1 long sheath was delivered to the opening of the coronary sinus through the right femoral vein, and the right coronary finger guide tube (JR4) was placed to the opening of the coronary sinus. The guide tube was rotated clockwise, and the tip of the guide catheter was pointed in the posterior-superior direction under the right anterior oblique 30 degree fluoroscopy. The BMW guide wire was sent to the proximal end of VOM, and the OTW balloon was sent to the middle and distal end of VOM. The balloon was expanded, and after the BMW guide wire was removed, the course of VOM and whether there was regurgitation were observed by angiography to ensure the complete occlusion of VOM. Anhydrous ethanol was injected in fractions via the OTW balloon.
- Conditions
- Atrial Fibrillation, Heart Failure
- Being tested
- VOM ethanol chemical ablation and 2C3L, 2C3L
- 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.
VOM ethanol chemical ablation and 2C3LProcedure or surgery
Annular pulmonary vein ablation, mitral isthmus line ablation, tricuspid isthmus line ablation, apex line ablation,anhydrous alcohol ablation of VOM
2C3LProcedure or surgery
Annular pulmonary vein ablation, mitral isthmus line ablation, tricuspid isthmus line ablation, apex line ablation
| Study group | Role | What they receive |
|---|---|---|
| 2C3L group | Sham comparator | Ablation Procedure:2C3L Receives: Procedure: 2C3L |
| 2C3L-plus group | Experimental | Ablation Procedure:2C3L combined with Marshall ethanol ablation Receives: Procedure: VOM ethanol chemical ablation and 2C3L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative recurrence rate
Postoperative recurrence rate was evaluated by holter monitoring.
Measured: 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start16 Jun 2022
- Primary completion16 Jun 2025 (estimated)
- Study completion16 Jun 2025 (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.
- More trials run by Qianfoshan 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qianfoshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hesheng Hu, Study director, Shandong First Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438692
- Sponsor's protocol ID
- 05949801
- Status last verified
- May 2024
- First submitted
- 2 Jan 2024
- Last updated
- 3 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the 2C3L Strategy Based on Marshall Venous Chemoablation for the Treatment of Persistent Atrial Fibrillation Combined With Heart Failure
- ClinicalTrials.gov ID
- NCT06438692
- Acronym / sponsor ID
- 05949801
- Conditions
- Atrial Fibrillation, Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Qianfoshan HospitalUniversity, hospital or other
- Study start
- 16 Jun 2022 (actual)
- Primary completion
- 16 Jun 2025 (estimated)
- Study completion
- 16 Jun 2025 (estimated)
- First posted
- 3 Jun 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.
(1) To evaluate the efficacy and safety of "2C3L" strategy combined with VOM anhydrous ethanol chemical ablation for persistent atrial fibrillation complicated with heart failure; (2) To evaluate the effectiveness of high-efficiency ablation of atrial fibrillation complicated with heart failure.
Detailed description
2C3L ablation strategy: The electroanatomical mapping system was the Carto 3 V6 system of Johnson \& Johnson, and the high-density mapping electrode (Pentaray) and cold saline perfusion pressure catheter (ST-SF) were used for ablation. Ablation parameters were set as follows: ablation power of 45 to 50 Watts (reduced to 25 Watts in the coronary vein and 35 Watts in the endocardium of the mitral isthmus), upper temperature limit of 43 ° C, and saline infusion rate of 15 mL/ min (changed to 30 mL/min in coronary veins), the pressure was controlled at 5-15 g, and the target AI was set: 480-500 for the anterior wall of the pulmonary vein, 350-380 for the posterior wall, 450 for the top of the left atrium, 600 for the mitral valve isthmus, and 450 for the tricuspid valve isthmus. A single catheter procedure was performed in the left atrium, and the ablation endpoint was to achieve continuous bilateral circumferential pulmonary vein damage with loss of intrapulmonary vein potential, which was further confirmed after conversion to sinus rhythm. During left pulmonary vein ablation, the top and posterior wall of left pulmonary vein were ablated first. If pulmonary vein isolation was achieved, no further intervention was performed on the anterior edge of left pulmonary vein. The ablation of the mitral annulus started from about 1 cm away from the junction between the VOM and the coronary vein, and continued to the low-voltage area. Ablation was performed in the corresponding epicardium, namely the coronary vein. Finally, the isthmus of the tricuspid valve was ablated from 6:00 to the inferior vena cava. If the patient still had atrial fibrillation or atrial flutter after the above ablation, 200 J direct current was used to cardioversion the sinus rhythm, and the complete block of each ablation path was verified by pacing during sinus rhythm. In the ablation-only group, catheter ablation was used only to these end points. The operation time was from the start of venipuncture to the removal of sheath tube. The melting time was the cumulative ablation time.
VOM absolute ethanol chemical ablation: The SL1 long sheath was delivered to the opening of the coronary sinus through the right femoral vein, and the right coronary finger guide tube (JR4) was placed to the opening of the coronary sinus. The guide tube was rotated clockwise, and the tip of the guide catheter was pointed in the posterior-superior direction under the right anterior oblique 30 degree fluoroscopy. The BMW guide wire was sent to the proximal end of VOM, and the OTW balloon was sent to the middle and distal end of VOM. The balloon was expanded, and after the BMW guide wire was removed, the course of VOM and whether there was regurgitation were observed by angiography to ensure the complete occlusion of VOM. Anhydrous ethanol was injected in fractions via the OTW balloon.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2C3L group | Sham comparator | Procedure: 2C3LAblation Procedure:2C3L |
| 2C3L-plus group | Experimental | Procedure: VOM ethanol chemical ablation and 2C3LAblation Procedure:2C3L combined with Marshall ethanol ablation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age:18y-80y
- First ablation on non valvular atrial fibrillation
- Persistent atrial fibrillation with LVEF≤40%
- The patient has symptoms related to atrial fibrillation, including but not limited to palpitations, premonitory syncope, syncope, fatigue, and shortness of breath, and is evaluated for clinical cardiac function between NYHA II-IV levels
- No response to antiarrhythmic drugs, unacceptable side effects, or unwillingness to take antiarrhythmic drugs.
Key exclusion criteria (10 listed)
- Paroxysmal atrial fibrillation
- Atrial fibrillation secondary to obvious reversible causes
- Echocardiography: Parasternal long axis section, left atrial diameter ≥ 60mm
- LVEF >40%
- Receiving dual antithrombotic therapy
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 |
|---|---|---|
| VOM ethanol chemical ablation and 2C3LAnnular pulmonary vein ablation, mitral isthmus line ablation, tricuspid isthmus line ablation, apex line ablation,anhydrous alcohol ablation of VOM | Procedure or surgery | 2C3L-plus group |
| 2C3LAnnular pulmonary vein ablation, mitral isthmus line ablation, tricuspid isthmus line ablation, apex line ablation | Procedure or surgery | 2C3L group |
Primary outcome
Postoperative recurrence rate
Time frame: 12 months after operation
Postoperative recurrence rate was evaluated by holter monitoring.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
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.
Hesheng Hu study director
Shandong First Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VOM ethanol chemical ablation and 2C3L and 2C3L in people with Atrial Fibrillation and Heart Failure, run by Qianfoshan 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 5 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 3 Jun 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. Some participants in this study may receive a placebo. 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 Hesheng Hu (13589112300, hyperhhs@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative recurrence rate (time frame: 12 months after operation). 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 3 Jun 2024.