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

NCT06363604 | Recruiting

• 1 other identifier: XHEC-C-2023-128-2
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Procedural complications

  through study completion, an average of 1 year

Study Arms (2)

VOMEI + PVI + linear ablation of mitral isthmus + PWI

EXPERIMENTAL

Acquisition of left atrial posterior wall isolation by linear ablation of LA roof and bottom line, in addition to routine strategy with vein of Marshall ethanol infusion, isolation of bilateral pulmonary veins and linear ablation of mitral isthmus.

Procedure: VOMEI + PVI + linear ablation of mitral isthmus; Procedure: Posterior wall isolation

VOMEI + PVI + linear ablation of mitral isthmus

ACTIVE COMPARATOR

Routine strategy with vein of Marshall ethanol infusion, isolation of bilateral pulmonary veins and linear ablation of mitral isthmus. Left atrial posterior wall not isolated.

Procedure: VOMEI + PVI + linear ablation of mitral isthmus

Interventions

VOMEI + PVI + linear ablation of mitral isthmus PROCEDURE

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.

VOMEI + PVI + linear ablation of mitral isthmus; VOMEI + PVI + linear ablation of mitral isthmus + PWI

Posterior wall isolation PROCEDURE

PWI is additionally performed for experimental group with linear ablation of LA roof and bottom line, and verified by mapping with a multielectrode catheter.

Also known as: PWI

VOMEI + PVI + linear ablation of mitral isthmus + PWI

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18-85 years old;
• Symptomatic, non-valvular persistent atrial fibrillation (atrial fibrillation duration ≥1 week), and refractory to at least one antiarrhythmic drug;
• Prepared to undergo atrial fibrillation catheter ablation;
• Provide informed consent to participate in the study, comply with follow-up trials and evaluation procedures.

You may not qualify if:

• 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;
• On the heart transplant list;
• Life expectancy less than 1 year;
• With other bleeding disorders that cannot be treated with anticoagulation therapy;
• With left atrial thrombus;
• Heart failure with NYHA class III-IV or LVEF\<40%;
• With uncontrolled malignant tumor;
• Obvious liver or kidney dysfunction (ALT, AST levels more than 2 times the upper limit of normal, and/or CCr\<50%);
• History of catheter radiofrequency ablation for atrial fibrillation or cardiac surgery;
• Women who are pregnant, breastfeeding, planning to become pregnant, or of childbearing age but not using reliable contraception.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Related Publications (19)

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  PMID: 34775069 RESULT

• 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 fibrillation. N Engl J Med. 2015 May 7;372(19):1812-22. doi: 10.1056/NEJMoa1408288.

  PMID: 25946280 RESULT

• 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.

  PMID: 34258794 RESULT

• 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.

  PMID: 29178497 RESULT

• 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;27(1):13-21. doi: 10.1111/jce.12830. Epub 2015 Oct 30.

  PMID: 26515166 RESULT

• 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 of the pulmonary vein antrum with or without left atrial posterior wall isolation in patients with persistent atrial fibrillation. Heart Rhythm. 2016 Jan;13(1):132-40. doi: 10.1016/j.hrthm.2015.08.019. Epub 2015 Aug 13.

  PMID: 26277862 RESULT

• 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: 10.1007/s10840-015-0024-2. Epub 2015 Jun 12.

  PMID: 26066661 RESULT

• 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.14591. Epub 2022 Sep 20.

  PMID: 36073753 RESULT

• 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 Electrophysiol. 2019 Nov;5(11):1253-1261. doi: 10.1016/j.jacep.2019.08.021. Epub 2019 Oct 30.

  PMID: 31753429 RESULT

• 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, Sanders P, Kalman JM. Effect of Catheter Ablation Using Pulmonary Vein Isolation With vs Without Posterior Left Atrial Wall Isolation on Atrial Arrhythmia Recurrence in Patients With Persistent Atrial Fibrillation: The CAPLA Randomized Clinical Trial. JAMA. 2023 Jan 10;329(2):127-135. doi: 10.1001/jama.2022.23722.

  PMID: 36625809 RESULT

• 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, Jais P, Haissaguerre M, Walton RD, Derval N. Epicardial course of the septopulmonary bundle: Anatomical considerations and clinical implications for roof line completion. Heart Rhythm. 2021 Mar;18(3):349-357. doi: 10.1016/j.hrthm.2020.11.008. Epub 2020 Nov 11.

  PMID: 33188900 RESULT

• 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-Analysis. Circ Arrhythm Electrophysiol. 2019 Aug;12(8):e007005. doi: 10.1161/CIRCEP.118.007005. Epub 2019 Aug 12.

  PMID: 31401853 RESULT

• 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 Marshall Ethanol Infusion vs Catheter Ablation Alone on Persistent Atrial Fibrillation: The VENUS Randomized Clinical Trial. JAMA. 2020 Oct 27;324(16):1620-1628. doi: 10.1001/jama.2020.16195.

  PMID: 33107945 RESULT

• 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.

  PMID: 33990979 RESULT

• 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 J Cardiol. 2022 Dec 1;368:41-48. doi: 10.1016/j.ijcard.2022.08.007. Epub 2022 Aug 8.

  PMID: 35952939 RESULT

• 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: 10.1155/2020/8615410. eCollection 2020.

  PMID: 32669982 RESULT

• 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/jce.13264. Epub 2017 Jun 23.

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MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yigang LI, Dr.

  Xinhua Hospital, Shanghai Jiaotong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yichi YU, Dr.

CONTACT

+8613585563975; yuyichi@xinhuamed.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study used a single-blind design for the subjects. A statistician created a random sequence of numbers using a randomization scheme. The sequence was then placed in opaque coded envelopes and sealed in numerical order. When a patient met the inclusion and exclusion criteria and was assigned a number, the researcher notified the manager to obtain the corresponding envelope and perform the intervention according to the grouping plan inside the envelope. Group 0 correspond to the control group not receiving PWI isolation, while group 1 correspond to the experimental group for PWI isolation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 0 (Control): VOMEI + PVI + linear ablation of mitral isthmus. Group 1 (Experimental): VOMEI + PVI + linear ablation of mitral isthmus + PWI

Study Record Dates

• First Submitted: January 21, 2024
• First Posted: April 12, 2024
• Study Start: December 1, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 12, 2024

Record last verified: 2024-01

Locations

CN (1)