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Last Updated: 01/06/2023

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13 Clinical Trials
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Evaluation of Clinical Outcomes of Transcatheter Transfemoral Mitral Valve-in-Valve Implantation in Polish Population- Observational Multicenter Registry

Summary: In recent years increasing number of mitral bioprosthesis implantation, especially in elderly population, is observed. Bioprosthetic valves are associated with a lower risk of thrombotic and bleeding adverse events compared with mechanical prostheses, but their use is limited due to their durability. After years numerous patients may develop bioprosthesis failure, requiring valve reintervention. S...

Quality of Life After Cardiac Surgery

Summary: During the last twenty years heart surgery has become safer and the number of patients having heart surgery has increased with more frail patients being offered increasingly complex surgery. Heart operations often improve survival and quality of life (QoL), but that is not true for all patients. Regarding survival, clinicians can measure the risk to life from having a heart operation and the risk ...

A Randomized, Open, Phase 2 Study to Evaluate the Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis

Summary: This study aims to compare the efficacy and safety of the edoxaban and the warfarin in atrial fibrillation patients with mitral stenosis. The study design is a multicenter, randomized, open-label, investigator initiated phase 2 trial. The patients were randomly assigned to Edoxaban or Warfarin groups. Primary outcome was a composite of stroke and systemic arterial thromboembolism. The safety outco...

Validation of B-type Natriuretic Peptide With N-terminal Pro B-type Natriuretic Peptide in Perioperative Risk Assessment

Summary: This is a single-centre, prospective study to determine the correlation and comparative thresholds between N-terminal pro-brain natriuretic peptide (NT ProBNP, Roche) and brain natriuretic peptide (BNP, Abbott) tests. The study population will include patients assessed in presurgical screening (PSS) or on the day of surgery (DOS) who are presenting for elective surgery requiring a minimum of one-n...

The Safety and Effectiveness of the SAPIEN 3 and SAPIEN 3 Ultra Valve in Patients With Symptomatic Severe Calcific Mitral Valve Disease With Severe Mitral Annular Calcification Who Are Not Candidates for Standard Mitral Valve Surgery.

Summary: A prospective multicenter study enrolling high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve disease. There are 2 arms in this study: Transseptal Valve-in-MAC (ViMAC) and a control arm of patients treated with medical treatment only which will include patients who can't be treated due to the presence of anatomical exclusion criteria or other exc...

Left Atrial Appendage (LAA) Clot With Severe Mitral Stenosis, Responders and Non-responders With Anticoagulation

Summary: Consecutive patients with severe mitral stenosis and clot in left atrial appendage (LAA) on transesophageal echocardiography fulfilling the inclusion criteria will be recruited for this study. An ACUSON 128-XP echocardiographic system equipped with omniplane and biplane transesophageal probes will be used for this study. TEE followed by CT Angiography will be performed according to the standard pr...

Inhibition of Aortic Valve Calcification Through the Carboxylation Mechanism of Matrix Gla Protein (MGP), Following Administration of Vitamin K2 (Menaquinone-7). Correlation With Mitral Annulus and Ascending Aorta Calcification.

Summary: A randomized 12-month trial will include two groups of 100 individuals aged over 50 years, with asymptomatic mild to moderate Aortic valve stenosis (AVA > 1 cm2, Vmax < 4 m/s). The first group of 100 individuals will serve as the intervention group that will receive 300 mcg of K2 vitamin on a daily basis, while the second group of 100 individuals will be the control group that will receive placebo...

Randomised Controlled Trial Into the Role of Ramipril in Fibrosis Reduction in Rheumatic Heart Disease: The RamiRHeD Trial Protocol

Summary: Objective propose: to investigate the effect of Ramipril in suppressing ST2 (suppression of tumorigenicity 2) in the cardiac mitral valve in patients with Rheumatic Heart Disease. We hypothesized that we hypothesized that ramipril will improve rheumatic mitral valve fibrosis through the downregulation of ST2.

A Phase IV Double-blind, Randomised, Parallel Group Comparison of the Efficacy and Safety of Preoperative Intravenous Ferric Carboxymaltose and Placebo in the Treatment of Patients Undergoing Elective or Urgent Cardiac Surgery

Summary: This study evaluates the efficacy and safety of single dose preoperative ferric carboxymaltose in the prevention of postoperative infections and blood transfusions in patients scheduled for cardiac surgery. Half of the patients will receive ferric carboxymaltose and half of the patients physiological saline solution as placebo.

Rationale and Design of Dabigatran for Mitral Stenosis Atrial Fibrillation Trial

Summary: Atrial fibrillation (AF) is the most common sustained cardiac arrythmia encountered in clinical practice and patients suffer from this are at increased risk of ischemic stroke and systemic thromboembolism due to the formation and embolism of left atrial thrombi. Current international guidelines recommend non-vitamin K oral anticoagulants (NOACs) for stroke prevention amongst these patients with no...

The Prospecive OBSERVational Munich Interventional MITRAl-Valve Registry

Summary: Prospective, single-center observational registry including all consecutive patients treated with transcatheter mitral or tricuspid valve therapy at the Deutsches Herzzentrum München, Germany.

Randomized Trial of Transcatheter Valve-in-Valve Intervention vs Redo Surgery for the Treatment of Structural Mitral Bioprosthetic Dysfunction

Summary: Transcatheter valve-in-valve implantation has emerged as a valid alternative to redo surgery for patients with surgical bioprosthetic dysfunction. Nowadays, transcatheter, transeptal mitral valve-in-valve replacement (TsMViV) has been adopted in many centers worldwide. Some studies report low rates of periprocedural morbidity and mortality and favorable hemodynamic parameters of valve performance....

Showing 1-12 of 13

Last Updated: 01/06/2023