Evaluation of PWI Assisted by Marshall Ethanolization in Ablation of Persistent Atrial Fibrillation

Atrial Fibrillation Clinical Trial

Official title:

Randomized Controlled Study of Atrial Posterior Wall Isolation (PWI) Assisted by Vein of Marshall Ethanol Infusion (VOMEI) and Pulmonary Vein Isolation in Persistent Atrial Fibrillation Ablation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06363604
• Other study ID #: XHEC-C-2023-128-2
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: November 2026

Study information

• Verified date: January 2024
• Source: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Contact: Yichi YU, Dr.
• Phone: +8613585563975
• Email: yuyichi[@]xinhuamed.com.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, randomized controlled, single-blind, multi-center clinical trial study aiming to investigate whether the strategy of posterior wall isolation (PWI) assisted by vein of Marshall ethanol infusion (VOMEI) could improve the success rate of persistent atrial fibrillation ablation.

Description:

A total of 260 participants with persistent AF who undergo radiofrequency catheter ablation and received VOMEI + PVI will be randomized assigned to two groups at 1:1 ratio.

Group 1: VOMEI + PVI + linear ablation + PWI; Group 2: VOMEI + PVI +linear ablation. The major endpoint (efficacy endpoint) is the recurrence of atrial tachyarrhythmias between 3-12 months during follow-up. The secondary endpoint (safety endpoint) is the occurrence of procedural complications.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: November 2026
• Est. primary completion date: September 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Between 18-85 years old;

2. Symptomatic, non-valvular persistent atrial fibrillation (atrial fibrillation duration =1 week), and refractory to at least one antiarrhythmic drug;

3. Prepared to undergo atrial fibrillation catheter ablation;

4. Provide informed consent to participate in the study, comply with follow-up trials and evaluation procedures.

Exclusion Criteria:

1. Presence of acute conditions such as acute phase after myocardial infarction (within 3 months), acute heart failure or new onset of cerebral infarction within 3 months;

2. On the heart transplant list;

3. Life expectancy less than 1 year;

4. With other bleeding disorders that cannot be treated with anticoagulation therapy;

5. With left atrial thrombus;

6. Heart failure with NYHA class III-IV or LVEF<40%;

7. With uncontrolled malignant tumor;

8. Obvious liver or kidney dysfunction (ALT, AST levels more than 2 times the upper limit of normal, and/or CCr<50%);

9. History of catheter radiofrequency ablation for atrial fibrillation or cardiac surgery;

10. Women who are pregnant, breastfeeding, planning to become pregnant, or of childbearing age but not using reliable contraception.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• VOMEI + PVI + linear ablation of mitral isthmus
The CS angiography is firstly performed to visualize the vein of Marshall. The ethanol infusion by anhydrous alcohol is then performed by using a guidewire and an OTW ballon. For radiofrequency catheter ablation, the standard procedure of pulmonary vein isolation is performed. All the enrolled persistent AF patients perform the routine linear ablation of mitral isthmus.
• Posterior wall isolation
PWI is additionally performed for experimental group with linear ablation of LA roof and bottom line, and verified by mapping with a multielectrode catheter.

Locations

Country	Name	City	State
China	Xinhua Hospital, Shanghai Jiao Tong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (19)

Bai R, Di Biase L, Mohanty P, Trivedi C, Dello Russo A, Themistoclakis S, Casella M, Santarelli P, Fassini G, Santangeli P, Mohanty S, Rossillo A, Pelargonio G, Horton R, Sanchez J, Gallinghouse J, Burkhardt JD, Ma CS, Tondo C, Natale A. Proven isolation — View Citation

Chen M, Li C, Liao P, Cui X, Tian W, Wang Q, Sun J, Yang M, Luo L, Wu H, Li YG. Epidemiology, management, and outcomes of atrial fibrillation among 30 million citizens in Shanghai, China from 2015 to 2020: A medical insurance database study. Lancet Reg He — View Citation

Chen M, Sun J, Wang QS, Zhang PP, Li W, Zhang R, Mo BF, Yu YC, Cai X, Yang M, Lian XM, Zhao Y, Gong C, Yu Y, Liu B, Feng X, Lu Q, Li YG. Long-term outcome of combined catheter ablation and left atrial appendage closure in atrial fibrillation patients. Int — View Citation

Clarke JD, Piccini JP, Friedman DJ. The role of posterior wall isolation in catheter ablation of persistent atrial fibrillation. J Cardiovasc Electrophysiol. 2021 Sep;32(9):2567-2576. doi: 10.1111/jce.15164. Epub 2021 Jul 21. — View Citation

Cutler MJ, Johnson J, Abozguia K, Rowan S, Lewis W, Costantini O, Natale A, Ziv O. Impact of Voltage Mapping to Guide Whether to Perform Ablation of the Posterior Wall in Patients With Persistent Atrial Fibrillation. J Cardiovasc Electrophysiol. 2016 Jan; — View Citation

He Z, Yang L, Bai M, Yao Y, Zhang Z. Feasibility, efficacy, and safety of ethanol infusion into the vein of Marshall for atrial fibrillation: A meta-analysis. Pacing Clin Electrophysiol. 2021 Jul;44(7):1151-1162. doi: 10.1111/pace.14263. Epub 2021 May 24. — View Citation

Hylek EM, Go AS, Chang Y, Jensvold NG, Henault LE, Selby JV, Singer DE. Effect of intensity of oral anticoagulation on stroke severity and mortality in atrial fibrillation. N Engl J Med. 2003 Sep 11;349(11):1019-26. doi: 10.1056/NEJMoa022913. — View Citation

Kistler PM, Chieng D, Sugumar H, Ling LH, Segan L, Azzopardi S, Al-Kaisey A, Parameswaran R, Anderson RD, Hawson J, Prabhu S, Voskoboinik A, Wong G, Morton JB, Pathik B, McLellan AJ, Lee G, Wong M, Finch S, Pathak RK, Raja DC, Sterns L, Ginks M, Reid CM, — View Citation

Lee JM, Shim J, Park J, Yu HT, Kim TH, Park JK, Uhm JS, Kim JB, Joung B, Lee MH, Kim YH, Pak HN; POBI-AF Investigators. The Electrical Isolation of the Left Atrial Posterior Wall in Catheter Ablation of Persistent Atrial Fibrillation. JACC Clin Electrophy — View Citation

Lin H, Chen YH, Hou JW, Lu ZY, Xiang Y, Li YG. Role of contact force-guided radiofrequency catheter ablation for treatment of atrial fibrillation: A systematic review and meta-analysis. J Cardiovasc Electrophysiol. 2017 Sep;28(9):994-1005. doi: 10.1111/jc — View Citation

Liu X, Gao X, Chen L, Shen L, Liu M, Xu Y. Clinical impact of posterior wall isolation in catheter ablation for persistent atrial fibrillation: A systematic review and meta-analysis. Pacing Clin Electrophysiol. 2022 Oct;45(10):1268-1276. doi: 10.1111/pace — View Citation

Mo BF, Sun J, Zhang PP, Li W, Chen M, Yuan JL, Yu Y, Wang QS, Li YG. Combined Therapy of Catheter Ablation and Left Atrial Appendage Closure for Patients with Atrial Fibrillation: A Case-Control Study. J Interv Cardiol. 2020 Jun 25;2020:8615410. doi: 10.1 — View Citation

O'Neill L, Hensey M, Nolan W, Keane D. Clinical outcome when left atrial posterior wall box isolation is included as a catheter ablation strategy in patients with persistent atrial fibrillation. J Interv Card Electrophysiol. 2015 Oct;44(1):63-70. doi: 10. — View Citation

Pambrun T, Duchateau J, Delgove A, Denis A, Constantin M, Ramirez FD, Chauvel R, Tixier R, Welte N, Andre C, Nakashima T, Nakatani Y, Kamakura T, Takagi T, Krisai P, Cheniti G, Vlachos K, Bourier F, Takigawa M, Kitamura T, Frontera A, Sacher F, Hocini M, — View Citation

Sugumar H, Thomas SP, Prabhu S, Voskoboinik A, Kistler PM. How to perform posterior wall isolation in catheter ablation for atrial fibrillation. J Cardiovasc Electrophysiol. 2018 Feb;29(2):345-352. doi: 10.1111/jce.13397. Epub 2017 Dec 26. — View Citation

Sun J, Chen M, Wang Q, Zhang PP, Li W, Zhang R, Mo BF, Han B, Li XJ, Du W, Zhao L, Wang H, Yang B, Wu Y, Cai X, Li C, Chen TZ, Li YG. Adding six short lines on pulmonary vein isolation circumferences reduces recurrence of paroxysmal atrial fibrillation: R — View Citation

Thiyagarajah A, Kadhim K, Lau DH, Emami M, Linz D, Khokhar K, Munawar DA, Mishima R, Malik V, O'Shea C, Mahajan R, Sanders P. Feasibility, Safety, and Efficacy of Posterior Wall Isolation During Atrial Fibrillation Ablation: A Systematic Review and Meta-A — View Citation

Valderrabano M, Peterson LE, Swarup V, Schurmann PA, Makkar A, Doshi RN, DeLurgio D, Athill CA, Ellenbogen KA, Natale A, Koneru J, Dave AS, Giorgberidze I, Afshar H, Guthrie ML, Bunge R, Morillo CA, Kleiman NS. Effect of Catheter Ablation With Vein of Mar — View Citation

Verma A, Jiang CY, Betts TR, Chen J, Deisenhofer I, Mantovan R, Macle L, Morillo CA, Haverkamp W, Weerasooriya R, Albenque JP, Nardi S, Menardi E, Novak P, Sanders P; STAR AF II Investigators. Approaches to catheter ablation for persistent atrial fibrilla — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of atrial arrhythmias	Efficacy endpoint: Including recurrence of atrial fibrillation, atrial flutter, and atrial tachycardia (sustaining more than 30s)	3 and 12 months from the date of procedure
Secondary	Procedural complications	Safety endpoint: Occurrence of of atrioesophageal fistula, pulmonary vein stenosis, pericardial tamponade, phrenic nerve injury, and embolism	through study completion, an average of 1 year