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Active clinical trials for "Aortic Valve Insufficiency"

Results 11-20 of 119

Transcatheter Aortic Valve Replacement Versu Surgical Aortix Valve Replacement for Treating Elderly...

Degenerative Aortic Valve DiseaseAortic Stenosis1 more

To date, no formal, randomized, prospective, head-to-head comparisons of surgical aortic valve replacement (SAVR) versus transcatheter aortic valve replacement (TAVR) have been undertaken in the severe aortic stenosis (AS) population with small aortic annuli. Objectives of the present study are to compare the hemodynamic performance (incidence of severe PPM and ≥ moderate AR) and clinical outcomes (death, stroke, major or life threatening bleeding) between TAVR and SAVR in patients with severe AS and small aortic annuli.

Active10 enrollment criteria

Comparison of the Balloon-Expandable Edwards Valve and Self-Expandable CoreValve Evolut R or Evolut...

Aortic Valve StenosisRegurgitation2 more

The treatment with transcatheter aortic valve implantation (TAVI) of patients with small (≤23mm) surgical bioprostheses remains a challenge due to the increased transvalvular residual gradients and high rates of severe prosthesis-patient mismatch (PPM) following the procedure.

Active4 enrollment criteria

ProspeCtive, nOn-randoMized, MulticENter Clinical Evaluation of Edwards Pericardial Bioprostheses...

Aortic StenosisMitral Stenosis3 more

The objective of this trial is to confirm that the modifications to tissue processing, valve sterilization and packaging do not raise any new questions of safety and effectiveness in subjects who require replacement of their native or prosthetic aortic or mitral valve.

Active31 enrollment criteria

THE ALIGN-AR EFS TRIAL: JenaValve Pericardial TAVR Aortic Regurgitation Study

Aortic Regurgitation

To collect information about treatment for severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.

Active10 enrollment criteria

The JenaValve ALIGN-AR Pivotal Trial

Aortic RegurgitationAortic Valve Insufficiency2 more

To collect information about treatment for symptomatic severe Aortic Regurgitation (AR), which affects the aortic valve in the heart. Aortic regurgitation is a condition where aortic valve in the heart does not close tightly and allows some blood to leak back into the heart chamber. Symptoms of aortic regurgitation may include fatigue and shortness of breath. The preferred treatment for severe aortic regurgitation is aortic valve replacement surgery.

Active10 enrollment criteria

Polish Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI) Registry

Aortic Valve StenosisAortic Valve Insufficiency2 more

In the past years a substantial shift away from mechanical heart valves occurred and bioprosthetic heart valves claimed majority of market shares irrespective of patients' age.This indicates that population with failed surgical bioprostheses requiring ViV-TAVI will grow significantly and therefore, meticulous prospective data collection is necessary for future analyses in order to better understand potential limitations of this procedure.

Recruiting3 enrollment criteria

J-Valve TF Early Feasibility Study

Aortic Valve DiseaseAortic Valve Insufficiency1 more

The main objective of this study is to assess the preliminary safety and effectiveness of the J-Valve TF System in patients with symptomatic severe native aortic regurgitation who are judged by a multi-disciplinary heart team to be eligible for the device and to be at high risk for open surgical aortic valve replacement.

Not yet recruiting36 enrollment criteria

TAVR in Adults With Pure Severe Aortic Regurgitation

Transcatheter Aortic Valve ReplacementAortic Regurgitation

The study aimed to evaluate the efficacy and safety of transcatheter aortic valve replacement (TAVR) in patients with severe native valve aortic insufficiency. It is a multicentre, observational cohort study. The primary endpoint consisted of a composite of all-cause death, disabling stroke, or rehospitalization for heart failure at 12 months postoperatively. According to previous research results and opinions of expert groups, the sample size was expected to be 76 cases.

Recruiting9 enrollment criteria

Aortic or Mitral Valve Replacement With the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis...

Aortic Valve InsufficiencyAortic Valve Regurgitation6 more

Collect data on the safety and clinical performance of the Braile Biomédica® Bovine Pericardium Valvular Bioprosthesis

Recruiting46 enrollment criteria

Assessment of Paravalvular Leak After TAVI by Hemodynamic Measurements and Cardiac MRI

Transcatheter Aortic Valve ReplacementHemodynamic Monitoring2 more

Rationale: Transcatheter aortic valve implantation (TAVI) has become the standard therapy for elderly patients with high surgical risks. Paravalvular leakage after TAVI is relatively common and there is conflicting evidence regarding the clinical impact of mild paravalvular leakage in self-expanding devices. Prospective data for self-expanding devices are required to compare the extent of paravalvular leakage as a result of device design. Grading paravalvular leakage after TAVI is difficult. Echocardiography and angiography systematically underestimate paravalvular leakage (PVL) as compared to cardiac MRI. Hemodynamic measurements are used to aid decision making directly after TAVI implantation. Prospective data comparing hemodynamic measurements with cardiac MRI are needed to design an optimal strategy to grade paravalvular leakage peri-operatively in order to optimize TAVI outcomes. Objective: To assess procedural hemodynamic measurements in patients with paravalvular regurgitation quantified by means of cardiac MRI (CMR) and to analyse its association with impaired clinical outcome during 5-year follow-up. Study design: This is a prospective, single center clinical trial. Patients will receive a TAVI. After implantation different hemodynamic indices of paravalvular leakage will be assessed. At 1 month a cardiac MRI will be performed to quantify the amount of paravalvular leakage. Standardized clinical follow-up will take place at discharge, 30 days, 3 months and yearly up to 5 years. Study population: Approximately 80 patients with severe symptomatic aortic valve stenosis with an indication for TAVI will be included. Intervention: Patients will undergo cardiac MRI on top of standard clinical care within 30 days after TAVI. Main study parameters/endpoints: The primary endpoint is defined as paravalvular leakage regurgitation fraction as measured by cardiac MRI. The secondary endpoint will comprise a composite of device success, early safety and clinical efficacy as defined by the Valve Academic Research Consortium-2 (VARC-2)(1) and will comprise death, vascular complications, stroke/ Transient Ischemic Attack (TIA), life threatening bleeding requiring transfusion, and acute kidney injury requiring dialysis.

Active20 enrollment criteria
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