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Aortic Stenosis clinical trials

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NCT ID: NCT06372301 Recruiting - Aortic Stenosis Clinical Trials

Dobutamine Stress Echocardiography in LF/LG Aortic Stenosis and Wild-type Transthyretin Amyloid Cardiomyopathy

DobAttrAS
Start date: April 2, 2024
Phase: N/A
Study type: Interventional

The goal of this prospective clinical study is improve the diagnosis of Low-flow low-gradient aortic stenosis (LF/LG AS), in patients with co-existing wild-type transthyretin cardiac amyloidosis (ATTRwt). The main question it aims to answer is whether the classic dobutamine-stress echocardiography can be used to determine AS severity in patients with ATTRwt and LF/LG AS This question will be tried to answer by comparing dobutamine stress echocardiography, with the invasively measured aortic valve area (which is considered as the gold standard). In addition we aim to assess the degree of myocardial fibrosis and amyloid infiltration, assessed by light microscopy and cardiac magnetic resonance (CMRI) and evaluation of myocyte mitochondrial function by high resolution respirometry and their relation to AS severity and hemodynamic response to dobutamine.

NCT ID: NCT06204783 Recruiting - Heart Failure Clinical Trials

Real-time Pressure Volume Loop Monitoring as a Guide for Enhanced Understanding of Changes in Elemental Cardiovascular Physiology During Therapeutic Strategies Aiming for Hemodynamic Optimization. Cohort II: Structural Heart Interventions (PLUTO-II)

PLUTO-II
Start date: November 14, 2022
Phase:
Study type: Observational

The aim of PLUTO-II is to use biventricular pressure-volume (PV) loop measurements to improve the understanding of direct changes in cardiac and hemodynamic physiology induced by transcatheter aortic valve implantation (TAVI) or tricuspid edge-to-edge repair (TEER). These procedures evoke immediate changes in cardiac mechanoenergetics, ventricular-vascular interaction as well as ventricular (in)dependency. Within the context of PLUTO-II, patients will undergo biventricular PV-loop measurements before and after TAVI or TEER. In future, the application of perprocedural PV loop monitoring may tailor the daily individual decision making process during structural interventions in the catheterization laboratory.

NCT ID: NCT06136689 Recruiting - Aortic Stenosis Clinical Trials

Role of Aortic Valve Composition in Pathophysiology and Diagnosis of Aortic Stenosis

COMP-AS
Start date: January 1, 2022
Phase:
Study type: Observational

The study aims to evaluate composition differences of aortic valves in different stages and phenotypes of aortic stenosis using non-invasive imaging and histology.

NCT ID: NCT06129331 Recruiting - Aortic Stenosis Clinical Trials

Aortic Stenosis and Cardiac Amyloidosis

Start date: March 1, 2023
Phase:
Study type: Observational

The dual pathology of aortic stenosis (AS) and cardiac amyloidosis (CA) is increasingly recognized. Even tough efforts have been undertaken to bring cohorts together, the largest cohort of AS-ATTR to date is <50 patients. It is the aim of the present international, multi-center registry to collect ~300 patients with AS-CA creating a big enough cohort to allow 1. thorough characterization of this condition 2. assessment of log-term clinical outcomes of AS-CA 3. assessment of effectiveness of amyloid-specific treatment on top of valve replacement

NCT ID: NCT06076824 Recruiting - Aortic Stenosis Clinical Trials

Glucocorticoid Treatment in Transaortic Valve Replacement to Reduce the Incidence of Conduction Disturbances (GLUCO-TAVR).

GLUCO-TAVR
Start date: August 12, 2023
Phase: Phase 4
Study type: Interventional

The goal of this phase IV, randomized, controlled and open-label study is to assess the efficacy of peri-procedure glucocorticoid treatment in the prevention of conduction abnormalities and the need for pacemaker implantation in patients undergoing transaortic valve replacement compared to placebo. Participants randomized to the intervention group will receive a single dose of intravenous Methylprednisolone 7 mg/kg/day on the day of the procedure (1 hour before), followed by 15 mg/12 hours of daily Prednisone for 5 days. The primary endpoint is a composite of permanent pacemaker implantation and the occurrence of new conduction abnormalities (any-degree AV block, bundle branch block, or non-specific intraventricular conduction disorder) at discharge, at 30 days and 1 year.

NCT ID: NCT06055751 Recruiting - Aortic Stenosis Clinical Trials

Long Term Evaluation of Cardiac Arrhythmias After Transcatheter Aortic Valve Implantation -The LOCATE Registry

Start date: September 22, 2023
Phase:
Study type: Observational [Patient Registry]

The purpose of the Long term Evaluation of Cardiac Arrhythmias after Transcatheter Aortic Valve Implantation (LOCATE) Registry is to perform long-term ambulatory monitoring of patients with severe aortic stenosis who undergo trans-catheter aortic valve implantation (TAVI) and develop new onset conduction system abnormalities post-procedure that do not require urgent permanent pacemaker (PPM) implantation. The primary objectives of this study are to assess the incidence of late onset heart block necessitating PPM implantation and to evaluate the incidence of new onset atrial fibrillation (AF) following TAVI. This study aims to provide valuable insights into the long-term cardiac health of TAVI patients and inform the development of improved treatment strategies for aortic stenosis patients with conduction system abnormalities.

NCT ID: NCT06047561 Recruiting - Aortic Stenosis Clinical Trials

The Scottish Aortic Stenosis LongiTudinal Imaging and biomarkeR (SALTIRE) Programme

SALTIRE
Start date: May 22, 2023
Phase:
Study type: Observational

The goal of this observational study is to understand the processes of what causes and accelerates the disease progress in aortic stenosis and following aortic valve replacement. Participants will undergo transthoracic echocardiography every 6 months, with annual visits for state-of-the-art scanning techniques including positron-emission tomography combined with computed tomography or magnetic resonance imaging with radiotracers designed to look at disease processes including fibrosis, calcification, inflammation and thrombosis activity.

NCT ID: NCT06008080 Recruiting - Aortic Stenosis Clinical Trials

Post-Market Clinical Follow Up Study With Navitor Valve

VISTA
Start date: September 29, 2023
Phase:
Study type: Observational

Evaluation of the safety and performance of the Navitor TAVI System in a Global Study

NCT ID: NCT06007222 Recruiting - Aortic Stenosis Clinical Trials

Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation Trial

Start date: April 6, 2023
Phase: Phase 4
Study type: Interventional

Aspirin group: Aspirin 100mg will be started within 24 hours after randomization, and continued aspirin 100mg/day the end of the study period. Non-antithrombotic group: No antithrombotic agents will be administered after randomization until the end of the study period.

NCT ID: NCT05958537 Recruiting - Aortic Stenosis Clinical Trials

High Flow Nasal Oxygen Cannula in Transcatheter Aortic Valve Replacement: Complications and Biomarkers

TAVR-Highflow
Start date: November 1, 2023
Phase: N/A
Study type: Interventional

Background Transcatheter aortic valve replacement is a risky procedure, performed in patients that can also be considered at risk of developing complications. The use of HFNO could be justified in this context and could improve the results and safety of these procedures. The use of HFNO during sedation for TAVR could increase oxygen content and minimise hypercapnia, which occurs frequently. This may have 2 potential benefits: one in terms of facilitating the patient's tolerance to anaesthetic sedation; and the other to optimise oxygen delivery to organs such as the brain, kidneys, and myocardium. Primary aim The number of oxygen desaturation episodes. An oxygen desaturation episode is defined as any episode of Sp02 <93% for more than 10 seconds. Method A single-center prospective randomised controlled clinical trial with 132 individuals comparing the use of High Flow Nasal oxygen (intervention group) with the conventional standard of care oxygenation with nasal cannula standard oxygenation (control group) of patients undergoing sedation for transfemoral TAVR. The randomisation process will be carried out with a 1:1 assignment, using the RedCap Clínic tool for this purpose. Both groups will be treated at the same centre and by the same interventional cardiology and anaesthesia team. Sedation regime will be based on Target controlled infusion (TCI) with propofol and remifentanil. Local anaesthesia will be infiltrated by interventional cardiologist prior obtaining femoral vascular access. 50 L/min with 0.6% FiO2 will be administered through a high-flow nasal cannula in the intervention group. In the control group, oxygen therapy will also be administered in all cases, using the usual procedure: oxygen therapy through a conventional nasal cannula and at a flow of 5 L/min.