- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05542017
Long-term Outcome Following Concomitant Surgical Ablation for Atrial Fibrillation at University Hospital Basel: A Retrospective Study
September 22, 2022 updated by: Elodie Hersperger, University Hospital, Basel, Switzerland
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
123
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Basel-Stadt
-
Basel, Basel-Stadt, Switzerland, 4031
- University Hospital Basel
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Freedom from AF one year after surgical ablation
Time Frame: 12 months
|
one-year success
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Freedom from atrial fibrillation (AF) and atrial flutter (AFL) after removal from antiarrhythmic drug therapy
Time Frame: from surgical ablation until 10th October 2019
|
from surgical ablation until 10th October 2019
|
|
|
Need of additional arrhythmia interventions
Time Frame: from surgical ablation until 10th October 2019
|
repeat ablation procedures, electrical cardioversion, pacemaker implantation or implantable cardioverter-defibrillator (ICD) implantation
|
from surgical ablation until 10th October 2019
|
|
Use of oral anticoagulation
Time Frame: from surgical ablation until 10th October 2019
|
from surgical ablation until 10th October 2019
|
|
|
Perioperative morbidity
Time Frame: from surgical ablation until 10th October 2019
|
from surgical ablation until 10th October 2019
|
|
|
Mortality
Time Frame: from surgical ablation until 10th October 2019
|
from surgical ablation until 10th October 2019
|
|
|
Evolution of left atrial size
Time Frame: from surgical ablation until 10th October 2019
|
from surgical ablation until 10th October 2019
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Eur Heart J. 2021 Feb 1;42(5):507. Eur Heart J. 2021 Feb 1;42(5):546-547. Eur Heart J. 2021 Oct 21;42(40):4194.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 26, 2018
Primary Completion (Actual)
October 10, 2019
Study Completion (Actual)
October 10, 2019
Study Registration Dates
First Submitted
September 12, 2022
First Submitted That Met QC Criteria
September 12, 2022
First Posted (Actual)
September 15, 2022
Study Record Updates
Last Update Posted (Actual)
September 26, 2022
Last Update Submitted That Met QC Criteria
September 22, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-00206
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Atrial Fibrillation
-
Medtronic Cardiac Ablation SolutionsRecruitingParoxysmal Atrial Fibrillation (PAF) | Persistent Atrial Fibrillation | Atrial Fibrillation (AF)Australia, United States, France, Belgium, Switzerland, Czechia
-
Boston Scientific CorporationRecruitingAtrial Fibrillation (AF) | Persistant Atrial FibrillationUnited States, Spain, Belgium, France, Netherlands, Germany, Hong Kong
-
AtriCure, Inc.Active, not recruitingPersistent Atrial Fibrillation | Atrial Fibrillation (AF) | Longstanding Persistent Atrial FibrillationUnited States
-
China National Center for Cardiovascular DiseasesRecruitingAtrial Fibrillation Ablation | Atrial Fibrillation (AF) | Radiofrequency Catheter Ablation | Atrial Fibrillation Recurrent | Pulsed Field AblationChina
-
Ablacon, Inc.CompletedArrhythmias, Cardiac | Atrial Fibrillation, Persistent | Persistent Atrial Fibrillation | Longstanding Persistent Atrial FibrillationGermany
-
CortexAblacon, Inc.Active, not recruitingAtrial Fibrillation | Arrhythmias, Cardiac | Arrhythmia | Atrial Flutter | Atrial Fibrillation, Persistent | Atrial Tachycardia | Atrial Arrhythmia | Atrial Fibrillation Paroxysmal | Atrial Fibrillation, Paroxysmal or PersistentUnited States, Belgium, Netherlands, Czechia
-
Maastricht University Medical CenterRWTH Aachen UniversityUnknownAtrial Fibrillation (Paroxysmal) | Atrial Fibrillation Recurrent | Atrial Fibrillation Common Gene VariantsNetherlands
-
Medtronic Cardiac Ablation SolutionsNot yet recruitingParoxysmal Atrial Fibrillation (PAF) | Persistent Atrial Fibrillation
-
University Medical Centre LjubljanaEnrolling by invitationPersistent Atrial Fibrillation | Persistent Atrial Fibrillation LongstandingSlovenia
-
Vivek ReddyBoston Scientific CorporationRecruitingParoxysmal Atrial Fibrillation | Persistent Atrial FibrillationUnited States
Clinical Trials on Surgical Ablation for Atrial Fibrillation
-
Population Health Research InstituteHamilton Health Sciences CorporationRecruiting
-
Eastbourne General HospitalWithdrawn
-
Stanford UniversityWithdrawnAtrial Fibrillation | Obstructive Sleep ApneaUnited States
-
L.V.A. BoersmaCompleted
-
Sacramento EP ResearchThe University of Texas Health Science Center, Houston; Beth Israel Deaconess... and other collaboratorsCompletedParoxysmal Atrial FibrillationUnited States
-
CathVision ApSMedicept IncCompletedCardiac Arrhythmia | Persistent Atrial FibrillationUnited States
-
Inova Health Care ServicesWithdrawnAblation of Atrial Fibrillation
-
CathVision ApSAKRN ConsultingCompletedAtrial FibrillationBelgium
-
Centro Medico TeknonNot yet recruiting
-
Hoag Memorial Hospital PresbyterianRecruiting