Aortic Stenosis, Severe

9

Review clinical trials related to Aortic Stenosis, Severe. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Not yet recruiting

Valvosoft Outcomes Registry for Real-World Evidence

The VALvosoft Outcomes Registry for Real-World Evidence (VALOR-PMCF) is a prospective, multicenter, single-arm post-market clinical follow-up (PMCF) registry designed to evaluate the long-term safety and effectiveness of the Valvosoft® non-invasive ultrasound therapy (NIUT) device in patients with severe symptomatic calcific aortic stenosis (sSAS). Valvosoft® delivers focused, high-intensity, short-duration ultrasound pulses to the aortic valve via a trans-thoracic approach, inducing non-thermal mechanical softening of calcified valve tissue. This registry will enroll up to 200 participants across approximately 20 clinical sites in Europe following CE marking. Participants will be followed from discharge through 12 months post-procedure to assess clinical outcomes, quality of life, echocardiographic parameters, and safety events in a real-world setting.

Participants needed: 200
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Cardiawave SAUpdated: Apr 14, 2026Locations: 6
Eligibility criteria

Suffering from calcific sSAS according to the definition presented in the curren... [+3]

Prosthetic aortic valve; [+3]

Status: Recruiting

A Study to Obtain Imaging Data in 40 Patients Having Transcatheter Aortic Valve Implantation (TAVI)

The aim of this study is to learn if the Computed Tomography scan (CT scan) and heart echo scan TransThoracic Echo scan (TTE or heart echo scan) taken before a Transcatheter Aortic Valve Implantation (TAVI) procedure can be used to predict how the new TAVI valve will perform in the future. To do this the investigators need the usual CT scan before and a new CT scan after the TAVI valve has been put in. At present a CT scan after TAVI procedure is not routinely done. Male and female patients with severe Aortic Stenosis (AS) will be asked to take part. The data from the scans along with routine measures that are taken will be used to assess if there has been any deterioration in the valve at six months. The scan data collected will be used in a computer programme. This programme will be trained to predict TAVI valve performance. The main purpose of this study is to collect the CT scan data before and after the TAVI procedure. The study aims to answer: • Can the investigators obtain additional CT imaging data and other data before and after TAVI to enable the prediction of valve performance? Participants will be asked if they would have another CT scan 6 months after their TAVI procedure, during their routine follow up.

Participants needed: 40
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Barts & The London NHS TrustUpdated: Sep 3, 2025Locations: 1
Eligibility criteria

≥ 18 years of age [+16]

Life expectancy <6 months [+15]

Status: Recruiting

Influence of Lung Ultrasonography on the Prognosis and Postoperative Outcomes in Cardiac Surgical Patients

The goal of this interventional is to assess advantages of the ultrasound examination of the lungs in the early postoperative period in cardiac surgical patients after heart surgeries requiring cardiopulmonary bypass. Evaluation of pulmonary complications and outcomes during mid-term follow-up, as well as comparison of ultrasound examination and traditional roentgenologic methods (X-ray examination and CT of the chest) will be performed. The main question\[s\] it aims to answer are: * Is ultrasound examination of the lungs a more specific and sensitive method in identification of early postoperative pulmonary complications after on-pump cardiac surgical procedures, in comparison with traditional X-ray methods. * Does early identification of interstitial pulmonary edema (based on number of visualised B-lines in the early postoperative period), influences mid-term outcomes in this cohort of patients Participants will undergo ultrasound examination of the lungs on postoperative day 1, 3, 5 and 7 after heart surgery. Based on ultrasound findings and degree of interstitial pulmonary edema, medical (diuretics, anti-inflammatory, e.t.c) therapy will be modified. Researchers will compare this group of patients with control group, in which ultrasound examination will be performed in the same time frames, but no changes in medical management based on ultrasound findings will be made to see if timely administered medical therapy, based on ultrasound findings, can significantly improve symptoms, hospital lengths of stay and outcomes of this patients.

Participants needed: 186
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Saint Petersburg State University, RussiaUpdated: Dec 9, 2024Locations: 1
Eligibility criteria

open heart surgery with cardiopulmonary bypass (CPB) between 15 December 2023 an... [+1]

reoperations on the open heart with CPB [+4]

Status: Recruiting

Timing And Typology of ConducTIon disturbanCes During TAVI

The TACTIC-TAVI registry aims to collect information about a consecutive cohort of patients undergoing transcatheter aortic valve insertion. The registry is international, multi-centre and observational. The registry is planned to continue until the calculated sample size is achieved.

Participants needed: 490
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Istituto Clinico HumanitasUpdated: Jul 22, 2024Locations: 1
Eligibility criteria

Presence of previously implanted permanent cardiac pacemaker. [+7]

Status: Recruiting

PARTNER 3 Trial - Aortic Valve-in-Valve

This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.

Participants needed: 125
Trial details
Biological sex: AllType: InterventionalSponsor: Edwards LifesciencesUpdated: May 10, 2024Locations: 51
Eligibility criteria

Failing surgical or transcatheter bioprosthetic valve in the aortic position dem... [+5]

Surgical or transcatheter valve in the mitral position (mitral rings are not an... [+30]

Status: Recruiting

Exercise CMR in (p)LF-LG AS

Patient with paradoxical or conventional low-flow low-gradient aortic stenosis on echocardiographic assessment will undergo physiological exercise-stress CMR in addition to guideline recommended surveys prior to TAVR.

Participants needed: 100
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University of GöttingenUpdated: Nov 13, 2023Locations: 1
Eligibility criteria

paradoxical or conventional severe low-flow low-gradient aortic stenosis

CMR incapable device [+4]

Status: Not yet recruiting

Outcome Prediction in Patients With Aortic Stenosis After TAVI

This study will investigate changes right ventricular function and functional recovery metrics after transcatheter aortic valve implantation

Participants needed: 69
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: Guy's and St Thomas' NHS Foundation TrustUpdated: Sep 21, 2023Locations: 1
Eligibility criteria

Patients with symptomatic severe aortic stenosis (AVA <1.0 cm2/<0.6cm2/m2 or mea...

Extracardiac limitations of ambulatory exercise, cardiac rehab opt out, non-tran...

Status: Not yet recruiting

TAVIS Registry - Trilogy Heart Valve System for Management of Patients With Aortic Valve Disease

To collect information about the management of symptomatic severe Aortic Stenosis (AS) and Aortic Regurgitation (AR) using transcatheter aortic valve replacement (TAVI).

Participants needed: 600
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: JenaValve Technology, Inc.Updated: Jan 11, 2023Locations: 3Duration: 5 Years
Eligibility criteria

Patients who have signed ICF and are indicated by their doctors to be treated wi... [+4]

Patients who have known hypersensitivity or contraindication to Nitinol (titaniu... [+7]

Status: Recruiting

MRI in Randomised Cohorts of Asymptomatic AS

Aortic stenosis is narrowing of the aortic valve, and is the commonest type of valve disease requiring surgery. Current guidelines recommend waiting till patients develop symptoms (chest pain, breathlessness and dizzy spells/fainting) before possible open heart surgery to replace the valve is offered. However, studies using detailed 'MRI' scanning of the heart have shown that up to half of the patients already have 'scarring' in the heart by the time symptoms develop. Furthermore, scarring is not fully reversed even after surgery and is associated with worse outcome. This suggests that some patients are being offered treatment too late. Two randomised trials in the UK (EASY AS and EVOLVED) are currently investigating if valve replacement before symptoms will result in better survival. The aim of this study is to compare the effect of early valve replacement versus waiting for symptoms, on the amount of scarring in the heart. The investigators want to know if early treatment leads to less overall scarring at the end, and leads to better quality of life and recovery after surgery. The investigators will invite participants of the EASY AS and EVOLVED trials to have 1-2 MRI heart scans: at recruitment and 3 years after being randomly allocated to early aortic valve replacement vs 'watchful waiting'. The investigators will also assess the impact of the two treatment approaches on quality of life, disability-free survival (using questionnaires) and recovery after surgery. The results from this project will increase understanding of the results of the main trials, and lead to improved selection of patients with aortic stenosis who are likely to benefit from early surgery.

Participants needed: 230
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: University of LeicesterUpdated: Jan 5, 2022Locations: 1
Eligibility criteria

Willing to and able to consent [+4]

Contra-indication to MRI. [+2]