NCT05542017

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2018

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2019

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
Last Updated

September 26, 2022

Status Verified

September 1, 2022

Enrollment Period

1.6 years

First QC Date

September 12, 2022

Last Update Submit

September 22, 2022

Conditions

Keywords

Surgical AblationCardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • Freedom from AF one year after surgical ablation

    one-year success

    12 months

Secondary Outcomes (6)

  • Freedom from atrial fibrillation (AF) and atrial flutter (AFL) after removal from antiarrhythmic drug therapy

    from surgical ablation until 10th October 2019

  • Need of additional arrhythmia interventions

    from surgical ablation until 10th October 2019

  • Use of oral anticoagulation

    from surgical ablation until 10th October 2019

  • Perioperative morbidity

    from surgical ablation until 10th October 2019

  • Mortality

    from surgical ablation until 10th October 2019

  • +1 more secondary outcomes

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent concomitant surgical ablation for atrial fibrillation between January 2011 and January 2017 at the University Hospital of Basel. The study population consisted of patients with paroxysmal, persistent, and long-standing persistent AF as defined by the 2020 ESC-Guidelines. Surgical ablation was performed concomitant to cardiac surgery addressing valvular or ischemic heart disease.

You may qualify if:

  • concomitant surgical ablation for atrial fibrillation
  • performed between January 2011 and January 2017 at University Hospital Basel

You may not qualify if:

  • stand-alone procedure
  • surgical ablation for atrial flutter

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

Location

Related Publications (2)

  • Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-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. No abstract available.

    PMID: 32860505BACKGROUND
  • 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. No abstract available.

    PMID: 29016841BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 12, 2022

First Posted

September 15, 2022

Study Start

February 26, 2018

Primary Completion

October 10, 2019

Study Completion

October 10, 2019

Last Updated

September 26, 2022

Record last verified: 2022-09

Locations