Long-term Outcome Following Concomitant Surgical Ablation for Atrial Fibrillation at University Hospital Basel: A Retrospective Study

Atrial Fibrillation Clinical Trial

Official title:

Long-term Outcome Following Concomitant Surgical Ablation for Atrial Fibrillation at University Hospital Basel: A Retrospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05542017
• Other study ID #: 2018-00206
• Status: Completed
• Start date: February 26, 2018
• Est. completion date: October 10, 2019

Study information

• Verified date: September 2022
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This retrospective single-centre study aims to examine the success rate of concomitant surgical ablation in patients with atrial fibrillation (AF) with an up to eight years follow-up period. Moreover, the focus of this study was to identify variables which predict freedom from AF, such as the type of AF, lesion set performed, energy source used and the patient's characteristics.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: October 10, 2019
• Est. primary completion date: October 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• concomitant surgical ablation for atrial fibrillation

• performed between January 2011 and January 2017 at University Hospital Basel

Exclusion Criteria:

• stand-alone procedure

• surgical ablation for atrial flutter

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Surgical Ablation for Atrial Fibrillation
Surgical ablation in combination with other cardiac procedures through a median sternotomy or thoracotomy. Main procedures were valve surgery (i.e. repair, replacement) and/or coronary artery bypass grafting (CABG). Surgical ablation procedures for atrial fibrillation were divided into three different groups according to Heart Rhythm Society (HRS) expert consensus 2017: (1) Pulmonary vein isolation alone; (2) Pulmonary vein isolation combined with left atrial lesion sets; (3) and biatrial procedure.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel	Basel-Stadt

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation: Executive summary. Europace. 2018 Jan 1;20(1):157-208. doi: 10.1093/europace/eux275. Review. — View Citation

Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomström-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. Erratum in: Eur Heart J. 2021 Feb 1;42(5):507. Eur Heart J. 2021 Feb 1;42(5):546-547. Erratum in: Eur Heart J. 2021 Oct 21;42(40):4194. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from AF one year after surgical ablation	one-year success	12 months
Secondary	Freedom from atrial fibrillation (AF) and atrial flutter (AFL) after removal from antiarrhythmic drug therapy		from surgical ablation until 10th October 2019
Secondary	Need of additional arrhythmia interventions	repeat ablation procedures, electrical cardioversion, pacemaker implantation or implantable cardioverter-defibrillator (ICD) implantation	from surgical ablation until 10th October 2019
Secondary	Use of oral anticoagulation		from surgical ablation until 10th October 2019
Secondary	Perioperative morbidity		from surgical ablation until 10th October 2019
Secondary	Mortality		from surgical ablation until 10th October 2019
Secondary	Evolution of left atrial size		from surgical ablation until 10th October 2019