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Aortic Valve Stenosis clinical trials

View clinical trials related to Aortic Valve Stenosis.

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NCT ID: NCT05836311 Not yet recruiting - Clinical trials for Aortic Valve Stenosis

Single Perclose Escalation Technique for Vascular Closure in TAVR

Start date: July 19, 2023
Phase:
Study type: Observational

This study examines in the safety and efficacy of using a single Perclose escalation technique (SPET) using a single Perclose Proglide device to preclose and the need for a rescue device based on a control angiography at the end of the procedure, with a 6F femoral sheath.

NCT ID: NCT05830760 Not yet recruiting - Clinical trials for Aortic Valve Stenosis

Expression of Sodium-glucose Co-transporter 2 in Human Heart

SGLT2-MICRA
Start date: June 2023
Phase: N/A
Study type: Interventional

The aim of the study is to evaluate the expression of Sodium Glucose Co-transporter 2 (SGLT2) in myocardium from patients with aortic stenosis. 2 groups of patients will be defined: Group A with diastolic heart failure and Group B without heart failure. The expression of SGLT2 will be measured on small myocardium specimens harvested during aortic valve replacement operation. This study should allow us to better understand the effect of glifozines in human heart failure.

NCT ID: NCT05813353 Completed - Clinical trials for Cognitive Impairment

Pre- and Post TAVI Cognitive Functioning and Intraoperative Carotid Flow Measurements

Start date: July 14, 2021
Phase:
Study type: Observational

Purpose: 1. Measuring and optimize the usability of the BAMCOG (games to measure cognitive functioning) 2. Concurrent validation of BAMCOG with MoCA to see if BAMCOG can serve as a monitoring instrument/screener 3. Determination of carotid flow/cerebral blood flow pre- and post implant of prosthesis of aortic valve by ultrasound doppler measurements

NCT ID: NCT05804903 Recruiting - Clinical trials for Transcatheter Aortic Valve Implantation

Investigation of the NVT ALLEGRA Plus THV System in Patients With Severe Aortic Stenosis or Failed Surgical Aortic Bioprosthesis

EMPIRE-II
Start date: November 24, 2023
Phase: N/A
Study type: Interventional

The EMPIRE II study evaluates the safety and performance of the entire ALLEGRA THV System. The primary safety endpoint is composite of all-cause mortality or stroke rates at 12 months. And the primary performance endpoint is device success at 7 days. Based on the outcomes of a study with a similar device and considering a drop-out rate of 5%, 177 patients need to be enrolled in the study.

NCT ID: NCT05788770 Recruiting - Clinical trials for Aortic Valve Stenosis

Preoperative CT-imaging With Patient-specific Computer Simulation in Transcatheter Aortic Valve Replacement: a Randomized Controlled Trial

GUIDE-TAVI
Start date: April 6, 2022
Phase: N/A
Study type: Interventional

Combining routine preoperative CT imaging with patient-specific computer modelling predicts the interaction between different sizes of transcatheter aortic valve replacement devices at different implantation depths and the patient's unique anatomy (including post-implantation deformation) allowing preoperative evaluation of the risk for paravalvular leakage and conduction disorders. The objective of this randomized controlled trial is to evaluate whether pre-operative CT-imaging with advanced computer modelling and simulation (FEops HEARTguideā„¢) adequately predicts procedural outcomes in TAVR procedures, whether it leads to changes of preoperative decisions and whether or not this leads to improved outcome in TAVR procedures.

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).