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Tiara* Transcatheter Mitral Valve Replacement Study

To evaluate the safety and performance of the Neovasc Tiara MitralTranscatheter Heart Valve with the Tiara Transapical Delivery System.Data collected in this clinical study will include 30-day safety and performance ofthe device and delivery system…

The PULSTA(TM) Transcatheter Pulmonary Valve (TPV) Pre-Approval Study

The primary objective is to evaluate the safety and effectiveness of the PULSTA TPV System for the treatment of congenital or acquired heart disease with pulmonary valve disease and to gain data that will lead to CE mark approval for the PULSTA TPV…

Transfemoral Replacement of Aortic Valve with HLT MeriDIAN Valve CE Mark Trial

To evaluate the safety and performance of the HLT System in patients with symptomatic heart disease due to severe aortic stenosis who are judged by a Heart Team to be at Intermediate or High Risk for aortic valve replacement surgery

Improved Diagnostic Strategies in Staphylococcus aureus bacteraemia

Primary objectives1. Determine prospectively the accuracy of proposed clinical criteria to assess the risk of SA-IE and complicated SAB2. Determine the diagnostic accuracy of cCT for SA-IE in patients with SAB3. Determine the diagnostic and…

Medtronic PERIcardial SurGical AOrtic Valve ReplacemeNt Pivotal Trial (PERIGON) Long-term Follow-Up.
A multi-center, non-randomized trial to determine the safety and effectiveness of the Model 400 aortic valve bioprosthesis in patients with aortic valve disease.

To evaluate the safety and effectiveness of the Model 400 Aortic Valve Bioprosthesis. LTFU:To evaluate the long-term safety and effectiveness of the Avalus Bioprosthesis.

An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated with the Abbott TriClipTM Device

To confirm the safety and performance of the TriClip* Tricuspid Valve Repair System in a real-world setting.

A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Performance of the Leaflex* Performer

The purpose of this study is to demonstrate the safety and performance of the Leaflex* when used for aortic valve repair in patients with symptomatic severe aortic stenosis. The main performance objective is to demonstrate an acute increase in…

ATTR amyloidosis in patients undergoing transcatheter aortic valve replacement: from prevalence to hemodynamic consequence.

Objective: 1. Investigate the prevalence of ATTR in patients undergoing TAVR in the Netherlands.2. To determine whether ATTR influences the effectiveness of TAVR treatment on LV dysfunction.

PROVE ACURATE neo2TM - post market safety and performance surveillance in aortic stenosis

To further evaluate the safety, efficacy and device performance of the ACURATE neo2* aortic bioprosthesis and ACURATE neo2* transfemoral delivery system in 2000 consecutive patients with severe aortic stenosis according to VARC-3 criteria.

Risk factors for progression of aortic valve stenosis

- To document the average progression of AVS in a large population of patients with mild to moderate AVS.- To assess the prevalence of elevated Lp(a) among patients with mild to moderate AVS.- To identify lipid and genetic risk factors for AVS.

Trifecta GT Post Market Clinical Follow-up

The objective of this study is to evaluate the safety and performance of the Trifecta* GT valve through 5 year follow-up in a prospective, multi-center, real-world setting. This study is intended to satisfy post-market clinical follow-up…

Endovascular covered stent as a treatment of vascular complications after TF-AVI

This study will assess the patient* health status regarding vascular symptoms after TF-AVI procedure together with stent function and the rate of stent fractures

A prospective, single arm feasibility pilot study to evaluate the safety and performance of the TriGUARD*3 Embolic Protection Device in patients undergoing Transcatheter Aortic Valve Implantation (TAVI)

The primary objective of the TriGUARD 3 * First in Man trial is to demonstrate the safety and performance of the TriGUARD*3 in patients undergoing TAVI.

MISSION-Registry: Assessing clinical outcomes using the EDWARDS INTUITY Elite Valve Systyem in isolated AVR using Minimally InvaSive Surgery In a EurOpean multi-ceNter, active, post-market registry.

Primary Objective:To compare the Cross Clamp Time collected with EDWARDS INTUITY Elite to published data with a conventional valve within a MIS approachSecondary Objectives:To describe short term (30 days) and long term (6 months) clinical safetyTo…

A comparison between rivaroxaban-based strategy and antiplatelet-based strategy following successful TAVR for prevention of leaflet thickening and reduced leaflet motion as evaluated by four-dimensional, volume-rendered computed tomography (4DCT) in a population of patients coming from the GALILEO randomized trial

Evaluate whether a rivaroxaban-based strategy, following successful TAVR, compared to an antiplatelet-based strategy, is superior in reducing subclinical valve leaflet thickening and motion abnormalities - as evaluated by 4DCT imaging at three…

Surgical Replacement and Transcatheter Aortic Valve Implantation Trial 10 Year Follow-up

The objective of this trial is to characterize annually the safety and durability data through 10 years in a subset of subjects randomized in the SURTAVI trial.

SAFETY AND PERFORMANCE OF THE TRIALIGN PERCUTANEOUS TRICUSPID VALVE ANNULOPLASTY SYSTEM (PTVAS) FOR SYMPTOMATIC CHRONIC FUNCTIONAL TRICUSPID REGURGITATION

To assess the safety and performance of the Trialign System for the treatment of symptomatic chronic functional tricuspid regurgitation in patients with a minimum of moderate tricuspid regurgitation.

Von Willebrand Factor to Identify high-risk patients with aortic Stenosis during Exercise - WISE study

HypothesisThe hypothesis of this pilot study is that vWF (both HMWV-multimers and CT-ADP) changes within minutes during exercise in patients with moderate and severe aortic stenosis due to increased flow and shear stress. Further studies need to…

Portico Alternative Access; Assessment of the St. Jude Medical Portico Resheathable Aortic Valve System - Alternative Access

The purpose of this clinical investigation is to expand the indication of the Portico TF Delivery System and obtain approval of the Alternative Access Delivery System to place a Portico transcatheter aortic valve through an alternative access site,…

BIOTRONIK - Safety and clinical performance of the self-expanding transcatheter BIOVALVE prosthesis in subjects with severe symptomatic calcified aortic valve stenosis suitable for transfemoral transcatheter aortic valve implantation (TAVI)

To evaluate the safety and clinical performance of the BIOVALVE prosthesis in subjects presenting with severe symptomatic aortic valve stenosis, which are as judged by the heart team, indicated for transfemoral transcatheter aortic valve…