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NCT05774821
Surgical Treatment of Tricuspid Valve Regurgitation in Patients With Cardiac Implantable Electronic Devices: Long Term Results
trial testing Tricuspid valve surgery in Tricuspid Regurgitation in 151 participants. Completed in 27 February 2022.
27 February 2022
Quick facts
| Lead sponsor | Michele De Bonis |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 151 |
| Start date | 4 February 2022 |
| Primary completion | 27 February 2022 |
| Estimated completion | 27 February 2022 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Tricuspid valve surgery
Conditions studied
- Tricuspid Regurgitation — all drugs for Tricuspid Regurgitation →
Sponsor
Michele De Bonis
Who can join
18 and older, any sex, with Tricuspid Regurgitation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Old trials aimed to evaluate Implantable Cardioverter-Defibrillator (ICD) safety and efficacy demonstrated a meaningful decreased rates of sudden death but an increased rate of hospitalization for heart failure . At the time, the chance that an endocardial lead could cause a significant tricuspid regurgitation (TR), leading to worsening heart failure, was not widely considered. Whereas, it is now well established that in patients with cardiac implantable electronic device (CIEDs), moderate or severe TR occurs frequently and it is associated with increased mortality and hospitalization for heart failure. The present study aims to report the long-term results of tricuspid valve repair and replacement surgery in patients with CIEDs Indeed, patients with TR and CIEDs can be divided in 2 categories: CIEDs induced TR and CIEDs associated TR. In patients with CIEDs induced TR, the valve dysfunction is directly caused by the lead with several mechanism such as mechanical interference with tricuspid valve (TV) leaflet mobility and coaptation (impingement), valve damage during lead placement or manipulation and sub-valvular entanglement. In patients with CIEDs associated TR the valve dysfunction is not directly caused by the lead. In 2009 approximately 720 000 CIEDs were implanted worldwide \[7\] and since then a continuous increase of CIEDs implantation was registered, with an estimation of 1.4 millions of CIEDs implantation in 2023. With this impressive number of CIEDs requirement, the need for surgical or trans-catheter treatment of severe TR CIEDs induced or associated, increased steadily in the past years and it likely will continue to increase in the next years. However, limited data are available regarding the outcome of tricuspid valve surgery in patients with CIEDs, particularly for the long-term results. With this study we aim to report the long-term result of tricuspid valve repair and replacement in patients with CIEDs.
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 NCT05774821
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Related trials
Other trials of Tricuspid valve surgery
Trials testing the same drug.
- NCT05721417 — Long-term Outcomes of Isolated Tricuspid Valve Surgery According to Preoperative Clinical and Functional Staging · completed
Other recruiting trials for Tricuspid Regurgitation
Currently open trials in the same condition.
- NCT07509658 — TriClip Japan Post-Approval Study · recruiting
- NCT07042360 — Application of Comprehensive Non-invasive Assessment To Phenotype Tricuspid Regurgitation · recruiting
- NCT06833476 — TTVR STRONG Under Coverage With Evidence Development (CED) Study · recruiting
- NCT06836011 — A Multicenter Study on Atrioventricular Regurgitation in Transthyretin Amyloid Cardiomyopathy: Definition, Prevalence, a · recruiting
- NCT07085650 — The Multi-center Study of Comprehensive Atrial Fibrillation Regurgitation and Recurrent Events Evaluation · recruiting
Other Michele De Bonis trials
Trials by the same sponsor.
- 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
- NCT05774795 — LOng-Term Fate of Moderate Aortic Regurgitation Left Untreated at the Time of Mitral Valve Surgery · 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 NCT05774821 (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: 20 March 2023
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