Endocardial Mapping of Left Atrium for Evaluation of Concomitant Surgical Ablation Lesions

Atrial Fibrillation Clinical Trial

— PLAN-AF  

Official title:

Endocardial Mapping of Left Atrium for Evaluation of Concomitant Surgical Ablation Lesions for Treatment of Atrial Fibrillation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05714800
• Other study ID #: PLAN-AF
• Status: Recruiting
• Start date: December 10, 2023
• Est. completion date: June 3, 2025

Study information

• Verified date: August 2023
• Source: University Medical Centre Ljubljana
• Contact: Matevž Jan, MD
• Phone: 0038615228238
• Email: matevz.jan[@]kclj.si
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Concomitant ablation is an effective treatment for patients with various types of atrial fibrillation undergoing heart surgery.

However, recurrences of tachycardias after concomitant ablation can happen and seem to be mostly related to reentry mechanism resulting in atrial tachycardias.

The aim of the study is to perform invasive re-mapping of ablated regions in the atria to assess durability of ablation lesions and prevalence of conduction gaps that can be targets for additional ablation to lower longterm arrhythmia recurrence.

Description:

Patients after concomitant ablation for treatment of atrial fibrillation will be enrolled. At ablation procedure pulmonary veins will be isolated and additional ablation lines will be performed in the left atrium (posterior wall box lesion, connecting lesion to the mitral annulus, connecting lesion to the left atrial appendage,...) and the right atrium (intercaval connecting lesion, cavotricuspid isthmus lesion,...) and left atrial appendage will be excluded (suture and excision, clipping device,...) at the discretion and expertise of the operator. Radiofrequency and/or cryoablation will be used at the discretion and expertise of the operator.

Invasive mapping with a high density mapping catheter connected to a three-dimensional electro-anatomical mapping system will be performed to assess pulmonary vein isolation and linear lesion durability 3 months after the initial concomitant ablation. Potential gaps will be identified and ablated with a radiofrequency ablation catheter.

Participants will be followed-up clinically and with holter ECG before and after the invasive re-mapping procedure up to the first year after the concomitant ablation procedure.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 3, 2025
• Est. primary completion date: June 3, 2024
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• all patients scheduled for any kind of elective heart surgery having also indication (EHRA and/or HRS guidelines) to undergo concomitant ablation for any type of atrial fibrillation

Exclusion Criteria:

• life expectancy of less than one year,

• severe heart failure with left ventricular ejection fraction below 35%,

• emergency surgery due to a life threatening condition such as acute aortic dissection, papillary muscle rupture, acute endocarditis, major trauma,...

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Slovenia	University Medical Centre Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Centre Ljubljana

Country where clinical trial is conducted

Slovenia, 

References & Publications (5)

Badhwar V, Rankin JS, Damiano RJ Jr, Gillinov AM, Bakaeen FG, Edgerton JR, Philpott JM, McCarthy PM, Bolling SF, Roberts HG, Thourani VH, Suri RM, Shemin RJ, Firestone S, Ad N. The Society of Thoracic Surgeons 2017 Clinical Practice Guidelines for the Surgical Treatment of Atrial Fibrillation. Ann Thorac Surg. 2017 Jan;103(1):329-341. doi: 10.1016/j.athoracsur.2016.10.076. — View Citation

Kornej J, Borschel CS, Benjamin EJ, Schnabel RB. Epidemiology of Atrial Fibrillation in the 21st Century: Novel Methods and New Insights. Circ Res. 2020 Jun 19;127(1):4-20. doi: 10.1161/CIRCRESAHA.120.316340. Epub 2020 Jun 18. — View Citation

Lippi G, Sanchis-Gomar F, Cervellin G. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021 Feb;16(2):217-221. doi: 10.1177/1747493019897870. Epub 2020 Jan 19. Erratum In: Int J Stroke. 2020 Jan 28;:1747493020905964. — View Citation

McCarthy PM, Kruse J, Shalli S, Ilkhanoff L, Goldberger JJ, Kadish AH, Arora R, Lee R. Where does atrial fibrillation surgery fail? Implications for increasing effectiveness of ablation. J Thorac Cardiovasc Surg. 2010 Apr;139(4):860-7. doi: 10.1016/j.jtcv — View Citation

McClure GR, Belley-Cote EP, Jaffer IH, Dvirnik N, An KR, Fortin G, Spence J, Healey J, Singal RK, Whitlock RP. Surgical ablation of atrial fibrillation: a systematic review and meta-analysis of randomized controlled trials. Europace. 2018 Sep 1;20(9):1442 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of conduction gaps	Prevalence of conduction gaps in pulmonary vein isolation lines and linear ablation lines found at the invasive re-mapping procedure	3 months
Primary	Prevalence of atrial fibrillation/tachycardia before and after delayed invasive re-mapping	ECG and holter ECG will be performed before and after the re-mapping procedure to assess possible change in prevalence related to closure of potential conduction gaps at the re-mapping procedure	12 months