Active clinical trials for "Heart Valve Diseases"

Rationale: Patients awaiting cardiac surgery can experience pre-procedural anxiety. This anxiety is associated with increased analgesic needs, increased risk of mortality and prolonged recovery time. Adequate patient education can help diminish pre-procedural anxiety and minimize postoperative complications. Recent studies have demonstrated that Virtual Reality (VR) can function as a useful tool to diminish pre-procedural anxiety in several medical fields. Especially 360 degree VR could familiarize patients with their clinical pathway. Nevertheless, limited to no research on the application of 360 degree VR has been conducted in the context of cardiothoracic surgery yet. Objective: The aim of this study is to explore the effects and possible benefits of 360 degree VR on pre-procedural anxiety in patients awaiting elective cardiac surgery involving a sternotomy, compared to standard forms of patient education. Study design: Single-center, randomized controlled trial Study population: Patients aged 18 or older awaiting elective cardiac surgery involving a sternotomy.

The goal of this clinical trial is to compare telehealth monitoring at home against usual care in patients undergoing planned heart surgery. The main questions it aims to answer are: Can telehealth improve quality of life prior to surgery Can telehealth prevent serious deterioration requiring hospital or primary care attendance Participants awaiting heart surgery will be randomly allocated to either telehealth remote monitoring of symptoms, blood pressure, heart rate, oxygen levels and activity levels or they will be allocated to usual care which is unmonitored on the waiting list for surgery. Researchers will compare telehealth to usual care to see if it improves quality of life or prevents deteriorations on the waiting list.

In this randomized clinical trial, the researchers are investigating whether a multi-component virtual cardiac rehabilitation program in addition to usual care will improve functional status, cholesterol level, overall cardiovascular health, individual risk factors, quality of life and mental health for patients who have recently been diagnosed with atherosclerotic cardiovascular disease, as compared to usual care.

In this prospective, single-arm study, we will look at the initiation, participation, sustained engagement, and safety of 100 adult subjects (ages 45 years or older) with recent (within the past 60 days) clinician referral to CR who are offered CTR via the RecoveryPlus platform. We want to understand the effectiveness of the RecoveryPlus platform in engaging participants in CR while remaining a safe alternative for the delivery of evidence-based CR content. The primary hypothesis of this study is that the RecoveryPlus CTR platform and patient-facing mobile application provide a safe alternative to traditional in-person CR, and demonstrate a high rate of initiation, participation, and engagement in CR exercise programming than traditional modes of CR delivery, as documented in the literature. Current in-person and non-personalized CR programming lacks RecoveryPlus' convenient remote access, easy-to-use digital tools to support independent, autonomous exercise, and a platform to facilitate engagement and feedback between patients and EPs.

Sleep apnea including obstructive sleep apnea (OSA) and central sleep apnea (CSA), are common in patients with cardiovascular disease. The prevalence of OSA is 2%-4% in general population and 16%-47% in surgical-heart failure patients. The previous studies found that the sleep apnea types shifted from OSA to CSA after continuous positive airway pressure (CPAP) treatment or from CSA to OSA after heart surgery (cardiac valve replacement/ repair or heart transplantation) without the mechanism illuminated clearly. The recent studies found that the loop gain (LG) could predict the effect of upper airway surgery and CPAP treatment on the reversion of OSA. However, in patients with valvular heart disease, whether LG and related parameters can predict the therapeutic efficacy of CPAP or cardiac valve replacement is not expounded clearly. The investigators' previous study found that there were different outcomes of sleep apnea after cardiac valve replacement: elimination or consistent. But the corresponding non-anatomic mechanisms was not clear. The investigators' preliminary experiment showed that the LG and related parameters were not improved while OSA improved by CPAP treatment; however, the recovery of OSA after cardiac valve replacement was closed related to the improvement of LG and related parameters. The investigators speculated that, 1. LG and related parameters could predict OSA outcome of CPAP treatment or cardiac valve replacement. 2. non-anatomic mechanisms including LG and associated parameters, contributed to CPAP treatment and cardiac valve replacement were different. In this study, the investigators aimed to explore the relationship between LG and, outcomes of OSA and the regarding non-anatomic mechanisms in patient with heart valve disease.

Considering decrease of major complications and improvement of procedural results, conductive disorders currently remain the main issue after TAVR (Transcatheter aortic valve replacement). While pacemaker implantation rate was about 10-15%, new onset LBBB (Left bundle branch block) was observed in 30 % of patients after TAVR but resolved at discharge in the majority of them, with less than 20% progressed to complete AV (atrioventricular) block requiring permanent pacing at hospital discharge. Higher implantation and improvement of the devices were associated with decline of pace maker implantation rate over the years in experienced teams. While guidelines do not give definite recommendation regarding conductive disorder management and pacemaker indication, a strategy of selective telemetry monitoring (TM) after TAVR according to the risk of conductive disorders may be proposed to limit indication and lenght of stay of intensive care unit admission (ICU), allowing direct admission of lower risk patients in general cardiology ward (GCW) without TM, to decrease the duration of TM when a conductive disorder is stable or regressive and finally to decrease the rate of pacemakers implantation. Potential benefit may also include limitation of ICU overload in high volume TAVR centers, investigators can also expect shorter hospitalization duration, with potential economic impact, in line with the development of algorithms for fast track procedures. Therefore the main objective of our prospective study was to evaluate feasibility and safety of a strategy of management of conductive disorders after TAVR based on an algorithm of diagnosis, monitoring and therapeutic strategies based on ECG analysis.

The CASPER study is a prospective, international, multicenter registry which aims to evaluate the use of an algorithm for choosing the size of the prosthesis to be implanted in patients with bicuspid aortic stenosis type I treated by TAVI with Evolut® Pro prostheses (23 -26-29) and Evolut® R 34.

NOTACS aims to determine if prophylactic use of high-flow nasal therapy (for a minimum of 16 hours after tracheal extubation) increases days at home in the first 90 days after surgery, for adult patients undergoing cardiac surgery who are at high risk of postoperative pulmonary complications. The study also incorporates a health economic analysis to estimate the incremental cost-effectiveness and cost-utility of HFNT versus standard oxygen therapy at 90 days, from the view-point of the public sector, NHS and patients.

The objective of the trial is to evaluate the procedural safety and efficacy of the Medtronic TAVR system in patients with bicuspid aortic anatomy and severe aortic stenosis at low risk for SAVR

This study is a prospective, single-arm, multi-center feasibility clinical study of the Tendyne Mitral Valve System for the treatment of eligible subjects with symptomatic, severe mitral regurgitation and severe mitral annular calcification (MAC). Subjects satisfying the study inclusion/exclusion criteria will undergo a procedure to implant the Tendyne mitral valve replacement device.