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Aortic Valve Stenosis clinical trials

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NCT ID: NCT05779787 Recruiting - Clinical trials for Aortic Valve Stenosis

COronary Re-engageMent aFter randOm NavitoR alignmenT (COMFORT STUDY)

COMFORT
Start date: February 15, 2023
Phase:
Study type: Observational

Whereas PCI before TAVR was previously recommended despite its uncertain prognostic role, recent data underline the possibility of a postponed coronary intervention using a commissural alignment technique. This approach allows easy coronary re-engagement through the valve stent frame with a trade off paid of procedure complexity. Considering the prevalence of coronary artery disease (CAD) and the increasing percentage of younger patients treated with TAVI, investigate whether a simpler procedure with random implantation of Navitor valve is not inferior in terms of coronary re-access, is required The key point of the project will be the evaluation of the feasibility of coronary re-engagement after a Navitor valve randomly implanted.

NCT ID: NCT05778773 Recruiting - Clinical trials for Aortic Valve Stenosis

OUTcomes Evaluation of Current Therapeutic STrategies for Severe Aortic Valve steNosis anD the agING Population in ITALY

OUTSTANDING
Start date: November 1, 2018
Phase:
Study type: Observational [Patient Registry]

In 2015 the Italian Ministry of Health invited the Cardiac Research Hospitals of Italy to constitute a Cardiac Network. The aim of the network is to facilitate and promote scientific and technological research in the setting of cardiovascular diseases and related risk factors. IRCCS (Scientific Research and Cure Institute) Policlinico San Donato is the responsible hospital for cardiac valve pathologies and has been appointed the leader for the present study. The non-calcific aortic valve stenosis in the elderly is one of the most frequent cardiovascular diseases. Different therapeutic options are available for treating this condition: medical therapy and follow-up, conventional surgery (including sternotomy and employment of mechanical, biological, or sutureless valves), and transcatheter valve implantation. The uncertainty about the advantages and limitations of the different approaches is still very high. In this panorama, the concept of mere survival should be replaced by a broader vision of the quality of life. The aim of the present study is to build an Italian registry of aortic valve stenosis in the elderly (age >= 65 years) who, following the current guidelines, would receive a biological aortic valve replacement. The following topics will be evaluated: (i) the results of the different therapeutical options; (ii) the determination of the choice criteria for the different therapeutical options and the verification of the appropriateness, economic and organizational impact for each of them; (iii) the evaluation of the quality of life modifications, periprocedural and at a long follow-up; (iv) the health technology assessment of the applied therapies.

NCT ID: NCT05774691 Recruiting - Clinical trials for Aortic Valve Stenosis

Routine Versus Selective Protamine Administration to Reduce Bleeding Complications After Transcatheter Aortic Valve Implantation (POPular ACE TAVI)

Start date: November 1, 2023
Phase: Phase 4
Study type: Interventional

Heparin reversal by protamine administration after transcatheter aortic valve implantation (TAVI) may reduce bleeding events. However, protamine can also cause life-threatening allergic reactions. High-quality evidence regarding the clinical safety and efficacy of routine protamine administration after TAVI is lacking. The aim of this clinical trial is to determine if routine protamine administration, compared with selective protamine administration, reduces the risk of cardiovascular mortality or bleeding within 30 days after transcatheter aortic valve implantation.

NCT ID: NCT05768594 Recruiting - Stenosis, Aortic Clinical Trials

Omics in Valvular Disease

OVERLOAD
Start date: November 15, 2019
Phase:
Study type: Observational [Patient Registry]

The aim of our study is to investigate the effects of impaired left ventricular remodeling on the short- and long-term prognosis in AS partecipants undergoing extracorporeal circulation during valve repair surgery and in partecipants undergoing implantation transcatheter. For the achievement of these purposes, markers obtained from will be considered cardiovascular imaging methods, such as color Doppler echocardiography and isolated biomarkers from peripheral blood and heart tissue.

NCT ID: NCT05758909 Recruiting - Clinical trials for Aortic Valve Stenosis

Evaluation of the Viability and Safety of Early Discharge Protocol After TAVI Implantation

FAST TRACK
Start date: April 4, 2023
Phase:
Study type: Observational [Patient Registry]

Evaluation of the safety and efficacy of early discharge (24 hours) after transfemoral transcatheter aortic prosthesis implantation (TAVI).

NCT ID: NCT05758662 Recruiting - Clinical trials for Aortic Valve Stenosis

The Effect of Subclinical Leaflet Thrombosis and Prosthesis Type on Transcatheter Aortic Valve Degeneration (POPular PET TAVI)

Start date: November 16, 2023
Phase:
Study type: Observational

A multicentre cross-sectional cohort study to assess the difference in bioprosthetic micro-calcification activity, detected with 18F-NaF PET-CT, as early marker of transcatheter valve degeneration, between patients with vs. without subclinical leaflet thrombosis at five years after TAVI; and between patients with intra-annular vs. supra-annular TAVI prostheses.

NCT ID: NCT05756608 Recruiting - Aortic Stenosis Clinical Trials

Fibrosis in Chronic and Delayed Myocardial Infarction

FCDMI
Start date: November 10, 2022
Phase:
Study type: Observational

In this study the investigators aim to examine the role that fibrosis plays in heart conditions such as aortic stenosis , chemotherapy-induced cardiotoxicity and carcinoid syndrome . Fibrosis is a common final result following any injury to the heart muscle and the investigators aim to identify this process early and in its active state. This will be examined by using a radiotracer 68Ga-FAPI or 18F-AlF-FAPI and PET-MRI or PET-CT.

NCT ID: NCT05751577 Recruiting - Clinical trials for Aortic Stenosis, Severe

TRanscatheter Aortic-Valve Implantation With or Without On-site Cardiac Surgery: the TRACS Trial

TRACS
Start date: May 1, 2023
Phase: N/A
Study type: Interventional

The primary efficacy objective is to determine whether a TAVI procedure performed by experienced operators in centers without on-site cardiac surgery is noninferior to TAVI procedure performed by the same operators in centers with on-site cardiac surgery in terms of all-cause death, stroke and rehospitalization for cardiovascular cause. The primary safety objective is to demonstrate that mortality associated with periprocedural complications actionable by emergent cardiac surgery did not differ between study arms.

NCT ID: NCT05739253 Recruiting - Aortic Stenosis Clinical Trials

Changes of Ascending Aortic Diameter in Patients Undergoing Transcatheter Aortic Valve Replacement

Start date: March 22, 2022
Phase:
Study type: Observational

The goal of this observational study is to assess the changes of ascending aortic diameter in patients undergoing transcatheter aortic valve replacement. The main questions it aims to answer are: 1. whether the ascending aortic diameter increases or remains stable after transcatheter aortic valve replacement, especially in patients with preoperative ascending aortic dilatation; 2. the determinants of postoperative ascending aortic dilatation.

NCT ID: NCT05714579 Recruiting - Clinical trials for Aortic Stenosis, Severe

Predictive Value of Pre-TAVI Infrahissian Conduction Time in the Occurrence of Complete Atrioventricular Block

TAVHIS
Start date: May 30, 2023
Phase: N/A
Study type: Interventional

The purpose of the study is implantation of a Pacemaker at 30 days for occurrence of a high-grade conduction disorder per- or post-procedure (yes/no)