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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
  • Hesheng Hu

    Jinan, Shandong, 250012

    Hesheng Hu, 13589112300

    Recruiting

Other trials in China

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.

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 groups in NCT06438692
Study groupRoleWhat they receive
2C3L groupSham comparatorAblation Procedure:2C3L
Receives: Procedure: 2C3L
2C3L-plus groupExperimentalAblation 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.

  1. 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.

  1. First posted3 Jun 2024
  2. Study start16 Jun 2022
  3. Primary completion16 Jun 2025 (estimated)
  4. Study completion16 Jun 2025 (estimated)

Resources

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)
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

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.

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