Clinical Research Directory

Balloon vs. Self Expanding Transcatheter Valve for Degenerated Bioprosthesis

Transcatheter aortic valve implantation (TAVI) serves a growing spectrum of patients with symptomatic severe aortic stenosis (AS). Approximately 80% of surgical aortic valve replacements are performed using a bioprosthesis. Durability of surgical bioprostheses varies according to patient age at the time of implantation, prosthesis type and size, among other factors. TAVI has become an established treatment option for patients with a degenerated surgical aortic bioprosthesis. The time from index surgical aortic valve replacement (SAVR) to bioprosthetic valve degeneration is typically 8-10 years. TAVI in this setting has shown favorable outcomes. Balloon-expandable and self-expanding transcatheter heart valves (THVs) can both be used for the treatment of a degenerated surgical aortic bioprosthesis and have specific advantages and limitations. Valve-in-valve TAVI may be associated with coronary obstruction, THV migration, paravalvular regurgitation, and prosthesis-patient mismatch. Objective: To compare valve-in-valve TAVI with balloon-expandable SAPIEN/MYVAL THV series versus the self-expanding EVOLUT THV series. The primary analysis evaluates device success at 30 days in the primary cohort. Continued enrollment will additionally support a secondary comparison of the safety and efficacy of the SAPIEN and MYVAL THV series. Study design: International multicenter randomized study with 1:1 randomization to TAVI with the EVOLUT THV series or the SAPIEN/MYVAL THV series. Study population: The primary cohort comprises 440 patients with a failing surgical aortic bioprosthesis (aortic stenosis with or without aortic regurgitation) selected for transfemoral TAVI by heart-team consensus. Enrollment of the primary cohort has been completed. The continued-enrollment cohort comprises 160 additional patients and will increase the total study population to 600 patients, with a target distribution of 300 patients treated with the EVOLUT THV series, 150 with the SAPIEN THV series, and 150 with the MYVAL THV series. Investigational intervention: Transfemoral valve-in-valve TAVI with a balloon-expandable SAPIEN or MYVAL THV series or a self-expanding EVOLUT THV series. Main study parameters/endpoints: 1. Primary endpoint is device success at 30 days Defined by: * Absence of procedural mortality; AND * Technical success at exit from the procedure room defined as freedom from mortality, successful access, delivery of the device and retrieval of the delivery system, correct positioning of a single prosthetic heart valve into the proper anatomical location, and freedom from surgery or intervention related to the device or to a major vascular or access-related, or cardiac structural complication; AND * Intended performance of the prosthetic heart valve (no severe prosthesis-patient mismatch and mean aortic valve gradient \<20 mmHg or peak velocity \<3 m/s, Doppler velocity index ≥0.25, and no moderate or severe prosthetic valve regurgitation). Severe prosthesis-patient mismatch is defined as an indexed effective orifice area (EOAi) ≤0.65 cm²/m² (≤0.55 cm²/m² if BMI ≥30 kg/m²). 2. Safety endpoint at 1 year defined by the composite of all-cause death, disabling stroke, rehospitalization for heart failure, or valve-related problems. 3. Secondary objective is comparison of the safety and efficacy of the SAPIEN versus MYVAL THV series, including the incidence of moderate or severe prosthesis-patient mismatch. The continued-enrollment cohort is designed to support this comparison.

Use of Artificial Intelligence-Guided Echocardiography to assIst cardiovascuLar Patient managEment

Heart Failure and valvular heart disease are disproportionate problems in rural and remote Australia (RRA). Echocardiography is the best imaging investigation, and essential for management, but access to this essential test shows huge geographic variations, primarily because of dependence on expert acquisition. This trial seeks to demonstrate the effectiveness of artificial intelligence-based echocardiography for triage and management of patients with known or suspected heart disease in RRA.

Post-Operative Myocardial Incident & Atrial Fibrillation

To explore predictors of major cardio-vascular events after cardiac surgery and trans-catheter valve implantation with a specific interest in studying mechanisms linking pre-operative leukocyte, fat and myocardial phenotypes with post-intervention outcomes.

Comparative Imaging Assessment of Valvular Heart Disease

The purpose of the study is to compare the various 2D and 3D methods of valvular heart disease quantification (Doppler, PISA, VCA, volumetric method) and strain with cardiac magnetic resonance (CMR) measurements of left and right ventricular systolic function strain and myocardial fibrosis assessment.

FRAILTY Classification Algorithm for the Corsano CARDIOWATCH 287-2: a Development and Validation Study

The FRAILTY-CARDIOWATCH study is investigating how well the Corsano CardioWatch 287-2, a wrist-worn medical device, can classify frailty in patients. Frailty is a condition often seen in older adults, characterized by decreased strength, endurance, and overall health, which can make individuals more vulnerable to illness or injury. The goal of this study is to develop an algorithm that can accurately assess frailty using the device. In phase 1 of the study, data will be collected from patients aged 70 or older who are scheduled for heart-related procedures, such as valve replacements or pacemaker implantation. The study aims to compare the frailty classifications of the CardioWatch with two established methods: the Geriatric 8 (G8) questionnaire and the FRAIL scale. It will also compare the CardioWatch with the 6-minute walk test. Patients will wear the CardioWatch for six days-three days before their procedure and three days after-and complete the G8, FRAIL, and 6-minute walk tests. The collected data will help develop and train the frailty classification algorithm. The main focus is to evaluate how well the frailty classifications from the CardioWatch match those from the other tests. This research could potentially lead to a more accurate and continuous way to monitor frailty in patients using wearable technology.

ChAracterization of Patients and Treatment OUtcomes in Severe Tricuspid Regurgitation

The goal of this observational study is to characterize the population of patients qualified for transcatheter tricuspid valve interventions (TTVI). It is expected to: * Describe the profile of patients qualified for TTVI * Establish the most common causes for disqualification from TTVI * Evaluate the immediate and long-term efficacy of TTVI * Evaluate TTVI safety Participants will undergo a standard qualification procedure for TTVI and then will be subject to a follow-up consisting of clinical examination, echocardiography and laboratory testing.

Allogeneic Valve Transplantation

Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve.

PREhabilitation in Patients Awaiting Acute Inpatient Cardiac SurgEry

This is a single centre, single arm pilot feasibility study to determine the feasibility and practicality of prehabilitation in acute inpatients waiting for cardiac surgery. We will be looking into participant eligibility, acceptability, recruitment rates, completion rates and barriers to implementing a prehabilitation programme. Secondary outcomes include safety (incidence of adverse events directly related to the study), improvement in 6 minutes walk test (6MWT), hand grip strength, quality of life, and spirometry. At the end of the trial, we will be seeking the feedback of the participants to help us improve the design further.

Transfusion in Cardiac Valve Surgery

This prospective, randomized controlled study is aimed to figure out suitable transfusion threshold in patients undergoing cardiac valve surgery under cardiopulmonary bypass(CPB). Patients are randomly assigned to restrictive and liberal transfusion group and receive blood transfusion during and after surgery. Compare primary and secondary outcomes of two groups.