A New Operation for the Treatment for Long-standing Atrial Fibrillation

NCT03347695 | Completed Results DMC

• 1 other identifier: CLW2017AF
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Atrial fibrillation(AF) often occurs in patients with mitral valve disease. Both mitral replacement and mitral valve plasty are the effective methods to the mitral valve disease. How to cure atrial fibrillation is the key to full recovery. Radiofrequency ablation (RFA) in surgery is an effective treatment for those patients. But there are some recurrence rate after RFA, particularly in patients with enlarged left atrium. So the investigators design a new procedure(Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure) during mitral surgery and study the outcomes to evaluate this new operation.

Conditions

Cardiovascular Disease

Keywords

atrial fibrillation; surgery

Outcome Measures

Primary Outcomes (3)

• Numbers of Participants Free From AF

  Freedom from AF in patients with longstanding persistent AF undergoing MVS at 6 months and 12 months. AF will be measured by 7 days continuous Holter monitoring at 6 months and 12 months post-surgery; and freedom of AF will be defined by absence of AF lasting \> 30 seconds at 12 months

  3, 6, and 12 months after the operation

• Intraoperative Cardiopulmonary Bypass Duration

  Cardiopulmonary bypass (CPB) technology is used in most cardiovascular surgeries. These surgeries utilize CPB, which has been associated with some adverse effects. This is most likely due to exposure of blood to abnormal surfaces and conditions leading to systemic inflammatory responses. Prolonged CPB duration is associated with worse clinical outcomes.

  1 hour after operation

• The Adverse Events Within 30 Days After Surgery

  The adverse events within 30 days after surgery, including: death, stroke, serious cardiac events (heart failure, myocardial infarction), cardiac re-hospitalizations, transient ischemic attack, pulmonary embolism, peripheral embolism, coronary artery injury, anatomical excessive bleeding, deep sternal wound infection/mediastinitis, damage to specialized conduction system requiring permanent pacemaker, and superior vena cava stenosis.

  Within 30 days after surgery

Secondary Outcomes (5)

• Change in Left Atrial Anteroposterior Diameter

  6 months and 12 months post-surgery

• Change in Left Atrial Transversal Diameter

  6 months and 12 months post-surgery

• Change in Left Atrial Superoinferior Diameter

  6 months and 12 months post-surgery

• The Number of Participants Who Will be Detected the Peak Late Trans-mitral Flow Velocity (A Wave) Reappearance

  6 months and 12 months post-surgery

• MACEs Within 12 Months After Surgery

  Within 12 months

Study Arms (2)

A new operation

EXPERIMENTAL

Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure

Procedure: Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients)

A new operation (Selected pilot study)

OTHER

Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure

Procedure: Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure

Interventions

Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients) PROCEDURE

Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure

A new operation

Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure PROCEDURE

Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure

A new operation (Selected pilot study)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to sign Informed Consent and Release of Medical Information forms
• Age ≥ 18 years and ≤ 60 years old
• Clinical indications for only mitral valve surgery for the following:
• Organic mitral valve disease without other cardiac disorders (functional or structural).
• Longstanding persistent AF is defined as continuous AF of greater than one year duration.
• Duration of AF must be documented by medical history and Presence of AF must be documented by a direct electrocardiographic assessment upon arrival in the clinic.
• Able to use heart rhythm monitor
• Anteroposterior diameter of left atrial between 45mm and 60mm

You may not qualify if:

• Able to sign Informed Consent and Release of Medical Information forms
• Age ≥ 18 years
• Clinical indications for mitral valve surgery for the following:
• Organic mitral valve disease; or Functional non-ischemic mitral regurgitation; or Ischemic mitral regurgitation with evidence of concomitant structural mitral valve disease.
• Note: May include need for surgical management of functional tricuspid regurgitation or patent foramen ovale. May also include concomitant CABG, aortic arch or aortic valve procedure. Surgical intervention may be performed via sternotomy or minimally invasive procedure.
• Longstanding persistent AF is defined as continuous AF of greater than one year duration.
• Duration of AF must be documented by medical history and Presence of AF must be documented by a direct electrocardiographic assessment upon arrival in the clinic.
• Able to use heart rhythm monitor
• AF without indication for mitral valve surgery; or
• AF is only or paroxysmal persistent; or
• Evidence of active infection; or
• Mental impairment or other conditions that may not allow patient to understand the nature, significance, and scope of study; or
• Surgical management of hypertrophic obstructive cardiomyopathy; or
• Previous catheter ablation for AF; or
• Life expectancy of less than one year; or

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Department of Cardiovascular Surgery,Union Hospital

Fuzhou, Fujian, 350001, China

Location

Related Publications (9)

• Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.

  PMID: 27042964 BACKGROUND

• 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 BACKGROUND

• Kim JH, Na CY, Lee SJ, Oh SS. Circumferential left atrium resection for treating a giant left atrium. J Card Surg. 2013 Mar;28(2):102-8. doi: 10.1111/jocs.12061. Epub 2013 Jan 29.

  PMID: 23356418 BACKGROUND

• Shi J, Bai ZX, Zhang BG, Ren WJ, Guo YQ. A modified Cox maze IV procedure: a simpler technique for the surgical treatment of atrial fibrillation. Interact Cardiovasc Thorac Surg. 2016 Dec;23(6):856-860. doi: 10.1093/icvts/ivw256. Epub 2016 Aug 11.

  PMID: 27521177 BACKGROUND

• Zheng S, Zhang H, Li Y, Han J, Jia Y, Meng X. Comparison of Left Atrial and Biatrial Maze Procedure in the Treatment of Atrial Fibrillation: A Meta-Analysis of Clinical Studies. Thorac Cardiovasc Surg. 2016 Dec;64(8):661-671. doi: 10.1055/s-0035-1554941. Epub 2015 Jul 28.

  PMID: 26220695 BACKGROUND

• Kong MH, Lopes RD, Piccini JP, Hasselblad V, Bahnson TD, Al-Khatib SM. Surgical Maze procedure as a treatment for atrial fibrillation: a meta-analysis of randomized controlled trials. Cardiovasc Ther. 2010 Oct;28(5):311-26. doi: 10.1111/j.1755-5922.2010.00139.x.

  PMID: 20370795 BACKGROUND

• Baek MJ, Na CY, Oh SS, Lee CH, Kim JH, Seo HJ, Park SW, Kim WS. Surgical treatment of chronic atrial fibrillation combined with rheumatic mitral valve disease: Effects of the cryo-maze procedure and predictors for late recurrence. Eur J Cardiothorac Surg. 2006 Nov;30(5):728-36. doi: 10.1016/j.ejcts.2006.08.016. Epub 2006 Sep 26.

  PMID: 17008109 BACKGROUND

• Kumar P, Athanasiou T, De L Stanbridge R. Treatment of long-duration atrial fibrillation by modified maze procedure. J R Soc Med. 2002 Nov;95(11):552-3. doi: 10.1258/jrsm.95.11.552. No abstract available.

  PMID: 12411621 BACKGROUND

• Chen L, Li Q, Chen J, Qiu Z, Xiao J, Tang M, Wu Q, Shen Y, Dai X, Fang G, Lu H. A new procedure for elimination of atrial fibrillation associated with mitral valve disease: a proof-of-concept study. Int J Surg. 2023 Oct 1;109(10):2914-2925. doi: 10.1097/JS9.0000000000000566.

  PMID: 37352525 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

\[Not Specified\]

Results Point of Contact

• Title: Dr. Liangwan Chen
• Organization: Fujian Medical University Union Hospital

chenliangwan@tom.com

861335825333

Study Officials

• Liangwan Chen, M.D

  Union Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The director of the department of cardiovascular surgery

Study Record Dates

• First Submitted: November 11, 2017
• First Posted: November 20, 2017
• Study Start: September 1, 2017
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: October 29, 2021
• Results First Posted: October 18, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available after the study ends.
• Access Criteria: cardiovascular researchers

Locations

CN (1)