Atrial FibrillationNCT05542017
Long-term Outcome Following Concomitant Surgical Ablation for Atrial Fibrillation at University Hospital Basel: A Retrospective Study
An observational study of Atrial Fibrillation and Maze Procedure, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation, Maze Procedure
- What is being tested?
- Surgical Ablation for Atrial Fibrillation
- Type of treatment
- Surgery or procedure
- How many people
- 123 participants
- Where
- 1 siteSwitzerland
- Study dates
- 26 Feb 2018to 10 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- concomitant surgical ablation for atrial fibrillation
- performed between January 2011 and January 2017 at University Hospital Basel
Who cannot join
- stand-alone procedure
- surgical ablation for atrial flutter
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4031
About this study
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.
- Conditions
- Atrial Fibrillation, Maze Procedure
- Being tested
- Surgical Ablation for Atrial Fibrillation
- Keywords
- Surgical Ablation, Cardiac Surgery
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Ablation for Atrial FibrillationProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from AF one year after surgical ablation
one-year success
Measured: 12 months
Secondary outcomes (6)
Freedom from atrial fibrillation (AF) and atrial flutter (AFL) after removal from antiarrhythmic drug therapy
Measured: from surgical ablation until 10th October 2019
Need of additional arrhythmia interventions
repeat ablation procedures, electrical cardioversion, pacemaker implantation or implantable cardioverter-defibrillator (ICD) implantation
Measured: from surgical ablation until 10th October 2019
Use of oral anticoagulation
Measured: from surgical ablation until 10th October 2019
Perioperative morbidity
Measured: from surgical ablation until 10th October 2019
Mortality
Measured: from surgical ablation until 10th October 2019
Evolution of left atrial size
Measured: from surgical ablation until 10th October 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start26 Feb 2018
- Primary completion10 Oct 2019
- Study completion10 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elodie Hersperger, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542017
- Sponsor's protocol ID
- 2018-00206
- Other IDs
- 2018
- Status last verified
- Sep 2022
- First submitted
- 12 Sep 2022
- Last updated
- 26 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 32860505Calkins 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.
PubMed 29016841
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Outcome Following Concomitant Surgical Ablation for Atrial Fibrillation at University Hospital Basel: A Retrospective Study
- ClinicalTrials.gov ID
- NCT05542017
- Acronym / sponsor ID
- 2018-00206
- Conditions
- Atrial Fibrillation, Maze Procedure
- Keywords
- Surgical Ablation, Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 26 Feb 2018 (actual)
- Primary completion
- 10 Oct 2019 (actual)
- Study completion
- 10 Oct 2019 (actual)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- concomitant surgical ablation for atrial fibrillation
- performed between January 2011 and January 2017 at University Hospital Basel
Key exclusion criteria (2 listed)
- stand-alone procedure
- surgical ablation for atrial flutter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical Ablation for Atrial FibrillationSurgical 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. | Procedure or surgery | – |
Primary outcome
Freedom from AF one year after surgical ablation
Time frame: 12 months
one-year success
6 secondary outcomes
Freedom from atrial fibrillation (AF) and atrial flutter (AFL) after removal from antiarrhythmic drug therapy
Time frame: from surgical ablation until 10th October 2019
Need of additional arrhythmia interventions
Time frame: from surgical ablation until 10th October 2019
Use of oral anticoagulation
Time frame: from surgical ablation until 10th October 2019
Perioperative morbidity
Time frame: from surgical ablation until 10th October 2019
Mortality
Time frame: from surgical ablation until 10th October 2019
Evolution of left atrial size
Time frame: from surgical ablation until 10th October 2019
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2022.
- Background: PubMed 32860505Hindricks 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.
- Background: PubMed 29016841Calkins 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.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation and Maze Procedure, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Freedom from AF one year after surgical ablation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05542017, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2022.