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NCT05836389
Long-term Results of Bilateral Thoracoscopic Ablation for Stand-alone Atrial Fibrillation
trial testing Pulmonary veins isoltation in bilateral thoracoscopy in Atrial Fibrillation in 56 participants. Completed in 30 June 2020.
30 June 2020
Quick facts
| Lead sponsor | Michele De Bonis |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 56 |
| Start date | 15 June 2020 |
| Primary completion | 30 June 2020 |
| Estimated completion | 30 June 2020 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Pulmonary veins isoltation in bilateral thoracoscopy
Conditions studied
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
Sponsor
Michele De Bonis
Who can join
Adults 20 to 80, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Atrial fibrillation (AFib) represents the most frequent cardiac arrhythmia whose prevalence appears to be increasing in the general population. Furthermore, this arrhythmia determines an increased risk of neurological complications (stroke) and, consequently, of mortality and morbidity. Currently, the first choice for the treatment of AFib is represented by the use of antiarrhythmic drugs. In patients who do not respond to pharmacological treatment, the ESC 2016 European guidelines recommend the execution of transcatheter ablation (Class I, level of evidence A). However, minimally invasive pulmonary vein isolation surgery (PVI) is recommended for subjects who are not even responsive to transcatheter ablation (Class IIa, Level of Evidence B). Previous studies have demonstrated good short-term results of thoracoscopic AFib ablation using PVI, with a 1-year freedom from atrial fibrillation recurrence without antiarrhythmic drugs of approximately 64-73%. However, only a few authors have described the medium-long term follow-up outcomes. The aim of this study is to report the long-term follow-up data of ablation of isolated, predominantly paroxysmal atrial fibrillation performed by isolation of the pulmonary veins by radiofrequency in bilateral thoracoscopy.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05836389
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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- Google Scholar
Related trials
Other recruiting trials for Atrial Fibrillation
Currently open trials in the same condition.
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- NCT07271238 — Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures · NA · recruiting
- NCT07388108 — Atrial Dyssynchrony to Predict Arrhythmias in the Postoperative Setting of Cardiovascular Surgery. · recruiting
- NCT07428967 — AV Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function · NA · recruiting
- NCT06650995 — AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure · NA · recruiting
Other Michele De Bonis trials
Trials by the same sponsor.
- NCT05774821 — Surgical Treatment of Tricuspid Valve Regurgitation in Patients With Cardiac Implantable Electronic Devices: Long Term R · completed
- NCT05774808 — Fate of Moderate Secondary Mitral Regurgitation in Patients Undergoing Aortic Valve Surgery for Severe Aortic Regurgitat · completed
- NCT05721417 — Long-term Outcomes of Isolated Tricuspid Valve Surgery According to Preoperative Clinical and Functional Staging · completed
- NCT05774769 — Commissural Closure to Treat Severe Mitral Regurgitation: Standing the Test of Time. · completed
- NCT05733988 — Edge-To-Edge Technique Used as a Bailout in Case of Sub-Optimal Mitral Repair: Very Long-Term Results · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05836389 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Michele De Bonis
- Last refreshed: 1 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05836389.
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