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Mitral Valve Disease clinical trials

View clinical trials related to Mitral Valve Disease.

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NCT ID: NCT05345730 Recruiting - Surgery Clinical Trials

The Role of Left Atrial Fibrosis in Mitral Valve Repair Surgery (ALIVE Trial)

ALIVE
Start date: February 2, 2022
Phase:
Study type: Observational

Rationale: Patients with mitral valve insufficiency suffer from left atrial remodeling. Atrial fibrosis is part of this remodeling process. The presence of atrial fibrosis is associated with adverse events. Currently, mitral valve repair surgery is the ultimate treatment for severe primary mitral valve insufficiency. The main indications and timing for surgery are severe mitral valve insufficiency with symptoms or left ventricular dysfunction. However, the role of atrial fibrosis in this process remains undetermined despite its well-recognized clinical implications. Characterization of atrial fibrosis patterns in mitral valve insufficiency patients might be potentially valuable for the indication and timing of mitral valve repair surgery in order to improve clinical outcomes. To date, however, mitral valve insufficiency patients suffering from left atrial remodeling have hardly been studied using these new imaging techniques. Therefore, the investigators intend to combine advanced cardiac MRI and post-processing techniques prior to and after mitral valve repair surgery to gain more insight in the clinical implications of atrial fibrosis in this patient population. It is hypothesized that the atrial fibrosis surface area paradoxically will increase after mitral valve surgery because of global shrinkage of the left atrium caused by the reversed remodeling process. As a consequence, more frequently atrial fibrosis related events including (paroxysmal) atrial fibrillation, may be observed in these patients. Objective: To assess the effects of (reduced) volume overload on the left atrial wall texture (presence, amount and location of atrial fibrosis) and associated geometry and function in patients with mitral valve insufficiency, prior to and after mitral valve repair surgery. Study design: Single center pilot study. Study population: The research population consists of mitral valve insufficiency patients scheduled for elective surgical mitral valve repair (N=20) according to the current European guideline criteria.

NCT ID: NCT05076604 Recruiting - Clinical trials for Aortic Valve Disease

Effects of Microplegia on Transfusion Rates After Cardiac Surgery

Start date: March 25, 2019
Phase: Phase 4
Study type: Interventional

This is a prospective, randomized study that is studying the rate of red blood cell (RBC) transfusion rates after planned heart (cardiac) surgery. The study will be conducted at Barnes-Jewish Hospital. Cardioplegia refers to the method of stopping (arresting) the heart in order to perform heart surgery. However, cardioplegia has also come to refer to the solution to achieve cardiac arrest as well as the machinery in which to deliver the solution. This study will investigate our current Standard Cardioplegia (diluted 4:1 blood cardioplegia) versus Microplegia (undiluted blood cardioplegia) to determine if Microplegia reduces peri-operative blood transfusion rates as compared to Standard Cardioplegia. All forms of cardioplegia will be delivered using the MPS2 Microplegia delivery machine by Quest Medical, Inc. Patients will be randomized to receive undiluted microplegia or standard 4:1 cardioplegia. The patient and the surgeon will be blinded to the randomization. Patients will be followed for 30 days post-operatively (or until their initial standard of care post-operative follow up visit with cardiac surgery if that appointment falls outside of the 30 day post-operative window) for the development of any adverse events as well as documentation of blood products given. We will draw one tube of blood for troponin levels at four time points; 1 draw before surgery (this may be done during the intraoperative period), and 3 draws post-operatively: ICU arrival, 12 hours post-ICU arrival and 24 hours post-ICU arrival. This is to closely monitor the patient for any heart tissue injury.

NCT ID: NCT04954404 Recruiting - Clinical trials for Mitral Valve Disease

Transcatheter Mitral Valve InterventiOn Single Center Registry in CHinese Patients With Mitral Valve Disease (TORCH-M)

Start date: May 1, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the safety and effectiveness of transcatheter mitral valve intervention in Chinese population with mitral valve disease.

NCT ID: NCT04916535 Recruiting - Clinical trials for Mitral Valve Disease

Prospective Multicenter Study on Mitral Annular Disjunction

MAD-NesS
Start date: June 3, 2021
Phase: N/A
Study type: Interventional

Observational cohort prospective multicenter study on patients with mitral annular disjunction (MAD). MAD is defined as a separation (≥1 mm) between the atrial wall-mitral valvular junction and the left ventricular free wall during end-systole

NCT ID: NCT04914468 Recruiting - Clinical trials for Mitral Valve Disease

Hamburg TranscathEteR Mitral Valve REplacement RegiStry

HERMES
Start date: March 8, 2021
Phase:
Study type: Observational

The Hamburg TranscathEteR Mitral Valve REplacement RegiStry (HERMES) is a prospective clinical cohort registry aiming to gather follow-up information on short- and long-term outcome of patients with mitral valve disease that undergo transcatheter mitral valve replacement (TMVR) screening. In particular, long-term durability and function of implanted bioprosteses is of utmost interest for both patients and clinicians. Moreover, this study aimes to investigate and compare the different treatment strategies patients undergo after successful or unsuccessful screening for TMVR.

NCT ID: NCT04787757 Recruiting - Clinical trials for Heart Valve Diseases

Autonomous Robotics for Transcatheter Cardiac Procedures

ARTERY
Start date: March 15, 2021
Phase:
Study type: Observational

Cardiovascular diseases represent the most common cause of death worldwide. Percutaneous approaches with intravascular catheters are pivotal, since they allow to treat patients with high perioperative risks. However, catheter-based treatments require steep learning curves and are characterized by poor ergonomics and exposure to damaging radiation. ARTERY will offer a radiation-free approach based on shared-autonomy robotic catheters, with increased user engagement and easy interaction. Intraprocedural three-dimensional echocardiography as well as computed tomography images obtained during usual clinical practice will provide artificial intelligence algorithms that will turn catheter navigation to a simple task. Optical and electromagnetic sensing techniques will ensure a superior view upon the cardiovascular anatomy and will guide the autonomous catheter upon the interventionist supervision, who will be able to take over control at any instant.

NCT ID: NCT04736667 Recruiting - Clinical trials for Mitral Valve Disease

Mitral Valve Screening Survey

MVSS
Start date: August 6, 2021
Phase:
Study type: Observational [Patient Registry]

This study aims to examine the clinical profile/anatomical characteristics and natural history of patients who subsequently fail screening for transcatheter mitral valve intervention (TMVI).

NCT ID: NCT04659655 Recruiting - Clinical trials for Aortic Valve Disease

VIenna Pilot Study for Automated Annular Suturing Technology

VIP-RAM
Start date: January 1, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to compare surgical outcomes between patients who underwent valve replacement with and without the help of the automated annular suturing technology. In addition, data of the early and intermediate postoperative period will be collected within routine clinical follow-up in order to assess morbidity and mortality as well as echocardiographic parameters.

NCT ID: NCT04408430 Recruiting - Clinical trials for Mitral Regurgitation

The MITRAL II Pivotal Trial (Mitral Implantation of TRAnscatheter vaLves).

MITRAL-II
Start date: March 8, 2021
Phase: N/A
Study type: Interventional

A prospective multicenter study enrolling high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve dysfunction (severe stenosis, ≥ moderate to severe regurgitation, or mixed ≥ moderate stenosis and ≥ regurgitation). There are 2 Arms in this study: 1) "Transseptal (TS) Valve-in-MAC" (ViMAC) Arm, and 2) Natural History of Disease Registry (NHDR) for patients treated with medical treatment only (which includes patients who meet inclusion criteria but can't be treated with transeptal ViMAC due to the presence of anatomical exclusion criteria or other exclusion criteria) and have not had other procedures that may impact outcomes (i.e., alcohol septal ablation or radiofrequency ablation). The study also includes a Registry of Permanently Unassigned" for subjects who undergo preemptive septal ablation procedures (alcohol or radiofrequency) in anticipation of continuing onto ViMAC arm, but are not accepted in the ViMAC Study arm or the patient chooses not to undergo ViMAC procedure.

NCT ID: NCT04231461 Recruiting - Clinical trials for Aortic Valve Stenosis

Quality of Life After Cardiac Surgery

QUACS
Start date: July 19, 2019
Phase:
Study type: Observational

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 to life from not quite precisely, but clinicians have little idea about the impact of heart operations on QoL, which is the outcome that patients care about most. Clinicians are unable to provide patients with robust information on how an operation will affect their QoL. This study will provide this information by analysing the data from patient questionnaires immediately before and after the procedure and monthly thereafter for 12 months.