Strategies for Antithrombotic Treatment Following Transcatheter Edge-to-edge Repair in Patients With an Indication for Oral Anticoagulant: a Multicenter Randomized Controlled Trial

Mitral regurgitation (MR) is the most common valvular heart disease, affecting approximately 24.2 million people worldwide (with a higher prevalence in older age groups). Transcatheter edge-to-edge repair (TEER) is now a well-established strategy in high-risk patients with MR. Globally, over 250,000 patients have benefited from the TEER technique.Studies have shown that patients with severe mitral regurgitation exhibit a high prevalence of atrial fibrillation (AF), reaching up to 63%, which is an indication for long-term oral anticoagulation (OAC) therapy. However, no dedicated study has prospectively evaluated different antithrombotic strategies following TEER in patients with an indication for OAC. Current guidelines do not provide any recommendations for the antithrombotic management of TEER. Consequently, considerable treatment variation exists in clinical studies and practice. The investigators will conduct a multicenter, open-label randomized trial to compare different antithrombotic strategies following TEER in patients who have an indication for OAC.

Start Date01 May 2025

Sponsor / Collaborator

Fuwai Cardiovascular Hospital

NCT06861998

/ Not yet recruitingNot ApplicableIIT

The Impact of Behavioral Intervention On Postoperative Delirium In Sleep-Disordered Infants and Toddlers Undergoing Congenital Heart Surgery: A Multicenter, Randomized Controlled Clinical Trial

This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in sleep-disordered infants and toddlers undergoing congenital heart surgery. The study will include infants and toddlers undergoing elective cardiac surgery with sleep disorders, assessed by the Brief Infant Sleep Questionnaire (BISQ). All participants will be randomly assigned to the intervention group and Controll group in a 1:1 ratio. The intervention group received sleep hygiene education and a bedtime routine based on touch, the control group received only sleep hygiene education. The primary outcome is the incidence of postoperative delirium within 7 days after surgery or before discharge, and secondary outcomes include postoperative sleep quality, pain score, perioperative organ injury (including AKI, acute lung injury, and postoperative liver dysfunction), clinical recovery and prognosis. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.

Start Date30 Apr 2025

Sponsor / Collaborator

Fuwai Cardiovascular Hospital

NCT06879431

/ Not yet recruitingNot ApplicableIIT

The Impact of Cognitive Behavioral Intervention On Postoperative Delirium In School-aged Children With Sleep Disorder Undergoing Congenital Heart Surgery: A Multicenter, Randomized Controlled Clinical Trial

This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in sleep-disordered school-aged children undergoing congenital heart surgery. The study will include infants and toddlers undergoing elective cardiac surgery with sleep disorders, assessed by the Children's Sleep Habits Questionnaire (CSHQ). All participants will be randomly assigned to the intervention group and Controll group in a 1:1 ratio. The intervention group received a short intensive cognitive-behavioral intervention 7-14 days before surgery, and no intervention was imposed on the control group. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.

Start Date28 Apr 2025

Sponsor / Collaborator

Fuwai Cardiovascular Hospital

100 Clinical Results associated with Fuwai Cardiovascular Hospital

0 Patents (Medical) associated with Fuwai Cardiovascular Hospital

254

Literatures (Medical) associated with Fuwai Cardiovascular Hospital

01 Apr 2025·Pediatric Cardiology

Assessing the State of Training in Congenital Interventional Cardiology: A Global Survey of Program Directors

Article

Author: Aggarwal, Varun ; Butera, Gianfranco ; Celebi, Ahmet ; Pan, Xiangbin ; Armstrong, Aimee K ; Sivakumar, Kothandam ; Hijazi, Ziyad M ; Kenny, Damien ; Boe, Brian ; Downing, Tacy ; Rossi, Raul Filho ; Whiteside, Wendy ; Linsky, Norm

This study aimed to evaluate the current state of congenital interventional cardiology training worldwide, with a focus on case volumes, competency assessment, and the need for ongoing mentorship during early career stages. A survey was conducted among program directors (PDs) of congenital interventional training programs across the globe. The survey gathered data on training pathways, case volumes, types of procedures performed, trainee competency assessment, and the role of ongoing mentorship. Of the 79 PDs who completed the survey, it was observed that training pathways and case volumes varied significantly, particularly between the United States and other countries. Most PDs reported an annual laboratory case volume of >500 congenital cardiac cases, with most cases being interventional. While trainees demonstrated competency in simple procedures (diagnostic cases, simple ASD closure), complex interventions (such as patent ductus arteriosus closure in premature infants) require ongoing mentorship for graduates. PDs recommended a minimum case volume of 400 total cases for trainees, including 250 interventional cases. In addition to case volumes, assessing trainee competency was deemed important, with clinical reasoning, judgment, skillset, teamwork, and complication management being key areas of evaluation. The study highlights the variability in congenital interventional cardiology training and the need for ongoing mentorship during the early career years. External mentorship programs, facilitated by national and international societies, are proposed to provide critical support for early career interventionalists thus enhancing patient care for congenital heart disease. Ultimately, the findings of this survey may serve as a framework for future training standards and guidelines in this specialized field.

01 Sep 2024·Canadian Journal of Cardiology

A New Scoring System Predicting Side-Branch Occlusion in Patients Undergoing Left Main Bifurcation Intervention: The LM V-RESOLVE Score

Article

Author: Cai, Zhongxing ; Zhang, Rui ; Dou, Kefei ; He, Jining ; Wang, Hao-Yu ; Yang, Min ; Xu, Bo ; Zheng, Zhihao

BACKGROUNDThe risk of side-branch (SB) occlusion is pivotal for decision making of stenting strategies during unprotected left main (LM) bifurcation percutaneous coronary intervention (PCI). Accordingly, this study aimed to develop a scoring system for predicting SB occlusion during unprotected LM bifurcation PCI.METHODSA total of 855 consecutive patients undergoing unprotected LM bifurcation PCI with provisional strategy at Fuwai Hospital from January 2014 to December 2016 were recruited. A prediction model was selected by means of all-subsets logistic regression, and a multivariable risk score (Left Main Visual Estimation for Risk Prediction of Side Branch Occlusion in Coronary Bifurcation Intervention [LM V-RESOLVE]) was then established with incremental weights attributed to each component variable based on its estimate coefficients. SB occlusion was defined as any decrease in Thrombolysis in Myocardial Infarction (TIMI) flow grade or absence of flow in SB after main vessel (MV) stenting.RESULTSSB occlusion occurred in 19 LM bifurcation lesions (2.22%). In multivariable model, 3 variables, including MV/SB diameter ratio, MV plaque ipsilateral to SB, and baseline diameter stenosis of SB, were independent predictors for SB occlusion (model C-statistic 0.829, 95% confidence interval [CI] 0.735-0.923, with good calibration). The risk score had a C-statistics of 0.830 (95% CI 0.738-0.923) with good calibration. Satisfactory discriminative ability of the risk score was also preserved in external validation (C-statistic 0.794, 95% CI 0.691-0.896).CONCLUSIONSThe LM bifurcation-specific novel scoring system, LM V-RESOLVE, based on 3 simple baseline angiographic findings, could help to rapidly discriminate lesions at risk of SB occlusion during LM bifurcation PCI.

01 Aug 2024·Stroke and Vascular Neurology

Associations of polygenic risk scores with risks of stroke and its subtypes in Chinese

Article

Author: Chen, Junshi ; Pei, Pei ; Lv, Jun ; Avery, Daniel ; Clarke, Robert ; Du, Huaidong ; Chen, Zhengming ; Pang, Yuanjie ; Sun, Dianjianyi ; Yu, Canqing ; Yang, Songchun ; Sun, Zhijia ; Burgess, Sushila ; Chen, Yiping ; Yang, Ling ; Sun, Dong ; Li, Liming ; Lu, Yan ; Walters, Robin G ; Millwood, Iona Y ; Guo, Yu

Background and purposePrevious studies, mostly focusing on the European population, have reported polygenic risk scores (PRSs) might achieve risk stratification of stroke. We aimed to examine the association strengths of PRSs with risks of stroke and its subtypes in the Chinese population.MethodsParticipants with genome-wide genotypic data in China Kadoorie Biobank were split into a potential training set (n=22 191) and a population-based testing set (n=72 150). Four previously developed PRSs were included, and new PRSs for stroke and its subtypes were developed. The PRSs showing the strongest association with risks of stroke or its subtypes in the training set were further evaluated in the testing set. Cox proportional hazards regression models were used to estimate the association strengths of different PRSs with risks of stroke and its subtypes (ischaemic stroke (IS), intracerebral haemorrhage (ICH) and subarachnoid haemorrhage (SAH)).ResultsIn the testing set, during 872 919 person-years of follow-up, 8514 incident stroke events were documented. The PRSs of any stroke (AS) and IS were both positively associated with risks of AS, IS and ICH (p<0.05). The HR for per SD increment (HRSD) of PRSASwas 1.10 (95% CI 1.07 to 1.12), 1.10 (95% CI 1.07 to 1.12) and 1.13 (95% CI 1.07 to 1.20) for AS, IS and ICH, respectively. The corresponding HRSDof PRSISwas 1.08 (95% CI 1.06 to 1.11), 1.08 (95% CI 1.06 to 1.11) and 1.09 (95% CI 1.03 to 1.15). PRSICHwas positively associated with the risk of ICH (HRSD=1.07, 95% CI 1.01 to 1.14). PRSSAHwas not associated with risks of stroke and its subtypes. The addition of current PRSs offered little to no improvement in stroke risk prediction and risk stratification.ConclusionsIn this Chinese population, the association strengths of current PRSs with risks of stroke and its subtypes were moderate, suggesting a limited value for improving risk prediction over traditional risk factors in the context of current genome-wide association study under-representing the East Asian population.

News (Medical) associated with Fuwai Cardiovascular Hospital

29 Aug 2024

·www.drugs.com

Weekend Catch-Up Sleep Could Do Your Heart Good

THURSDAY, Aug. 29, 2024 -- Like to sleep in on the weekends? You’re probably doing your heart a world of good, a new study shows. Weekend “catch-up” sleep can lower a person’s risk of heart disease by up to 20%, according to findings to be presented Thursday at the European Society of Cardiology’s annual meeting in London. “Sufficient compensatory sleep is linked to a lower risk of heart disease,” said researcher Yanjun Song , a cardiology expert with the Fuwai Hospital in Beijing. “The association becomes even more pronounced among individuals who regularly experience inadequate sleep on weekdays.” For the study, researchers analyzed data from nearly 91,000 participants in the long-range UK Biobank research project. As part of the project, the participants wore sleep monitors and had their heart health tracked. About 22% of the participants were sleep-deprived, getting less than seven hours of sleep per night. Sleep tracking showed which of the participants were sleeping in on the weekends, to make up for their lack of sleep during the week. After an average 14 years of follow-up, those participants who got the most catch-up sleep on the weekends were 19% less likely to develop heart disease than those who got the least, results show. That held especially true among those with daily sleep deprivation, with those getting the most catch-up sleep experiencing a 20% lower risk of heart disease, researchers said. Because these findings were presented at a medical meeting, they should be considered preliminary until published in a peer-reviewed journal. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Clinical Result

30 Jun 2023

·www.prnewswire.com

Bioheart (02185.HK) announces clinical result for Iberis-HTN at CIT 2023

SHANGHAI, June 29, 2023 /PRNewswire/ -- Bioheart (02185.HK), together with its holding subsidiary Angiocare announces the clinical result for Iberis-HTN at China Interventional Therapeutics 2023. Iberis-HTN is a prospective, multicenter, blinded, randomized controlled trial to evaluate the safety and efficacy of the Iberis® Multi-Electrode Renal Artery Radiofrequency Ablation Catheter System for the treatment of primary hypertension (NCT02901704). The study was led by Academician Runlin GAO and Professor Xiongjing JIANG from Fuwai Hospital. 217 subjects were enrolled in the trial. The results showed that the RDN group achieved the primary clinical endpoint of efficacy (change in mean systolic blood pressure from baseline during 24-hour ambulatory blood pressure at 6 months after the procedures) and was significantly superior to the sham control group. The 24-hour systolic ABPM for Renal denervation (RDN) group was reduced by 11.93 mmHg compared to baseline and the sham group was reduced by 2.58 mmHg. The net change between groups is 9.35 mmHg reduction with statistical significance (P<0.0001). No device related major adverse events were observed. The safety and efficacy of Iberis® were demonstrated in the study. About Iberis®2nd: Iberis®2nd is a catheter-based, procedure for the treatment of hypertension. Iberis®2nd has filed the registration application in China, received CE mark in EU in 2016 and has finished First in Human trial in Japan. Iberis® 2nd is currently the only RDN system globally with CE marking that can be used for both transradial approach (TRA) and transfemoral approach (TFA). TRA is preferred by interventionalists with fewer access site complications, shorter hospital stays and less overall procedural cost. TRA also enables RDN therapy to be conducted on an outpatient surgery basis. Iberis® 2nd can be used with 6F guiding to achieve complete ablation of renal main artery and branches resulting in better efficacy. A post-marketing trial RADIUS-HTN was initiated in 2022 in EU to compare the effectiveness of RDN performed via TRA and TFA. The principal investigator for RADIUS-HTN is Professor Felix Mahfoud, MD from Saarland University Hospital, Homburg/Saar and the chairman of the Arterial Hypertension Working Group of the German Cardiac Society. About Bioheart: Shanghai Bio-heart Biological Technology Co., Ltd is a leading cardiovascular innovative medical device company with global reach. Bioheart's mission is 'Turn innovation into quality care'. Bioheat focuses on Bioresorbable scaffolds, Renal Denervation and Drug coated balloons addressing unmet clinical needs. SOURCE Shanghai Bio-heart Biological Technology Co., Ltd

Clinical ResultAHA

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