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Aortic Valve Disease clinical trials

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NCT ID: NCT04897659 Completed - Clinical trials for Aortic Valve Disease

Left Bundle Branch Block (LBBB) After IntuityTM

Start date: January 1, 2021
Phase:
Study type: Observational

This study aimed to evaluate incidence, prognosis and predictive factors of new-onset of persistent left bundle branch block (LBBB) after rapid-deployment aortic valve replacement (RD-AVR) with the IntuityTM bioprosthesis. It was an observational, retrospective and single-center study. Two hundred and seventy-four consecutive patients without any baseline ventricular conduction disorder or previous permanent pacemaker or defibrillator implantation who underwent RD-AVR with the IntuityTM valve were included. Twelve-lead electrocardiogram and transthoracic echocardiography were performed preoperatively, postoperatively, at discharge, 1-month, and 1-year. Incidence, prognosis and predictive factors of new-onset of persistent LBBB were evaluated.

NCT ID: NCT04557345 Completed - Clinical trials for Aortic Valve Stenosis

Evaluation of the Inflammatory Response in Post-operated Aortic Valve Replacement Patients.

Start date: January 1, 1990
Phase:
Study type: Observational

Background Calcification of the aortic valve affects more than 26% of adult patients over 65 years of age and is the main indication for valve replacement in the United States of America. Previous evidence shows that aortic valve calcification is an active biological process associated with inflammation. The only actual treatment for severe aortic stenosis is surgical aortic valve replacement (AVR). The materials with which the different types of prostheses are manufactured could induce inflammation per se. Biological prostheses, an incomplete cell removal process and therefore, the presence of residual proteins of animal origin, could induce the immune system's response. In the manufacturing bioprosthesis at the "Ignacio Chávez" National Institute of Cardiology (INC), an evaluation was carried out in the early, and late post-surgical period, it was shown that the inflammatory response after six months is similar to that produced by mechanical prosthesis. This study's main objective is to evaluate the inflammatory response in patients with post-operated AVR due to biological or mechanical prosthetic valve through different plasma biomarkers in long-term follow-up. Research question What is the inflammatory response and calcification in patients who undergo aortic valve replacement for a manufactured prosthesis at the "Ignacio Chávez" National Institute of Cardiology in the long-term follow-up? Hypothesis Manufactured bioprostheses at the "Ignacio Chávez" National Institute of Cardiology show a similar or lower inflammatory response to imported bioprostheses or mechanical prostheses associated with less valve dysfunction and more outstanding durability.

NCT ID: NCT04491513 Completed - Clinical trials for Coronary Artery Disease

Detection of Proximal Coronary Artery Disease in the Work-up for Transcatheter Aortic Valve Implantation Using CTA (From the DEPICT CTA Database)

DEPICT CTA
Start date: October 1, 2019
Phase:
Study type: Observational

Background: Computed tomography angiography (CTA) is already used in the work-up for transcatheter aortic valve implantation (TAVI) and could partially replace invasive coronary angiography (CAG) to rule out proximal coronary lesions. Objectives: To assess the diagnostic accuracy and yield of pre-TAVI CTA to detect coronary lesions (≥50% DS and ≥70% DS) in the proximal coronary segments on a per-patient and a per-segment level. Methods: The DEPICT CTA database consists of individual patient data of four studies that analysed the diagnostic accuracy of pre-TAVI CTA to detect coronary lesions. For this analysis, diagnostic accuracy was assessed in the left main and the three proximal coronary segments.

NCT ID: NCT04455165 Completed - Clinical trials for Aortic Valve Disease

Factors Influencing Morbi-mortality in Right Anterior Minithoracotomy Approch for Aortic Valve Replacement

RVAOMITAVA
Start date: June 29, 2020
Phase:
Study type: Observational

Since 2009, positive experiences with right anterior minithoracotomy as an approach to aortic valve replacement are extensively practiced in our institution. The primary disease process for which patients are referred remains aortic stenosis. But more and more, we met older patients with both aortic stenosis and other cardiac pathology (coronary artery disease, other valvulopathy...). Even if minimally invasive valve surgery has been demonstrated to significantly improve postoperative course (reduced blood transfusion, pain, hospital lengths of stay) and to enhance postoperative recovery, when compared with a median sternotomy, it is however important to have medical data and statistics in order to better understand the factors influencing morbi-mortality and thereby to continue this improvement.

NCT ID: NCT04437303 Completed - Stroke Clinical Trials

Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)

Start date: November 25, 2020
Phase: Phase 4
Study type: Interventional

Transcatheter aortic valve implantation (TAVI) is a rapidly growing treatment option for patients with aortic valve stenosis. Stroke is a feared complication of TAVI, with an incidence of around 4-5% in the first 30 days. Up to 50% of patients undergoing TAVI have an indication for oral anticoagulants (OAC) mostly for atrial fibrillation. OAC use during TAVI could increase bleeding complications, but interruption during TAVI may increase the risk for thromboembolic events (i.e. stroke, systemic embolism, myocardial infarction). Recent observational data suggest that periprocedural continuation of OAC is safe and might decrease the risk of stroke. Beside the potential reduction of thromboembolic events, continuation of OAC is associated with an evident clinical ancillary benefit for patients and staff. Since periprocedural OAC interruption not infrequently leads to misunderstanding and potentially dangerous situations, when patients are not properly informed before hospital admission or may experience difficulties with the interruption regimen. Hypothesis: Periprocedural continuation of oral anticoagulants is safe and might decrease thromboembolic complications without an increase in bleeding complications at 30 days

NCT ID: NCT04401397 Completed - Clinical trials for Coronary Artery Disease

Effect of Early Mobilization on Length of Stay, Recovery and Readmission Rate of Patients After CABG or AVR/MVR Surgery

Start date: June 3, 2020
Phase: N/A
Study type: Interventional

The present study will investigate the volume and extent of the expected physiological effects of "early mobilization" on the prevention of the clinical illness' detrimental sequelae and on the functional recovery promotion of CABG, AVR and MVR patients. Consequently, it will investigate if the improved health outcomes may limit the number and intensity of complications and thus if it may speed up hospital discharge.

NCT ID: NCT04086836 Completed - Stroke Clinical Trials

Swedish Study on STroke After TAVR

SWESTAT
Start date: July 1, 2019
Phase:
Study type: Observational [Patient Registry]

This study aims at studying the frequency of late stroke after transcatheter aortic valve replacement/implantation

NCT ID: NCT04073875 Completed - Clinical trials for Aortic Valve Disease

18F-GP1 PET-CT to Detect Bioprosthetic Aortic Valve Thrombosis

Start date: October 22, 2019
Phase:
Study type: Observational

18F-GP1 binds with high affinity to the glycoprotein IIb/IIIa receptors on activated platelets. 18F-GP1 PET-CT has recently demonstrated favourable safety, pharmacokinetic, biodistribution and diagnostic performance for the in vivo identification of venous and arterial thrombemboli.

NCT ID: NCT04055883 Completed - Clinical trials for Calcific Aortic Valve Disease

Clinical Study to Evaluate Efficacy and Safety of DA-1229 in Patients With CAVD

DIP-CAVD
Start date: August 26, 2019
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of DA-1229 in patients with calcific aortic valve disease.

NCT ID: NCT03976817 Completed - Clinical trials for Aortic Valve Disease

Aortic Valve Replacement Above the Aortic Annulus (SA-AVR) With the Carpentier-Edwards Magna-Ease Bioprosthesis

SA-AVR
Start date: February 1, 2018
Phase:
Study type: Observational

Surgical valve replacement is commonly performed in patients with severe aortic valve disease. In small aortic annulus, implantation of bioprosthetic valves can be associated with limited functional capacity. To avoid this condition, we changed our surgical technique to implant a larger bioprosthesis. Briefly, the prosthesis is sutured to the aortic annulus along the left and right coronary sinuses, and in a supraannular position along the noncoronary sinus, therefore allowing us to insert a prosthetic valve with a one-size larger diameter than the native aortic annulus.