Trial reportJACC. Cardiovascular interventions2017
Mitral Loop Cerclage Annuloplasty for Secondary Mitral Regurgitation: First Human Results.
Trial report in JACC. Cardiovascular interventions, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 21 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Study on Safety and Feasibility of Mitral Loop Cerclage(MLC) Annuloplasty Procedure With Investigational Medical Device (MLC-B-45-75-R and Other 11 Models) : Single-centre, Open Label, Single Arm, Feasibility Test
The Study for Atrial Functional Mitral Regurgitation Response In Mitral Loop Cerclage Annuloplasty (AFRICA Study): Multi-center, Open Label, Single Arm, Feasibility Test
Who cites it
21 citing papers in PubMed, 44 citations in OpenAlex.
- Cerclage parahisian septal pacing through the septal perforator branch of the great cardiac vein: Bedside-to-bench development of a novel technique and lead.Heart rhythm · 2019Trial
- Technologies in minimally invasive treatment of severe mitral regurgitation.Cardiology journal · 2026Review
- Diagnosis and Diagnostic Challenges of Secondary Mitral Regurgitation in the Era of Transcatheter Edge-to-Edge Repair of the Mitral Valve.Journal of clinical medicine · 2025Review
- Trans-Coronary Sinus Intra-Septal Radiofrequency Ablation (TIRA) for Hypertrophic Obstructive Cardiomyopathy: First-in-Human Results.Biomedicines · 2024Article
- Cardiac Computed Tomography Identification of the Septal Vein-A Small Retrospective Study.Life (Basel, Switzerland) · 2024Article
- Novel percutaneous technique for creation of porcine model of tricuspid regurgitation via two routes.The Journal of international medical research · 2024Article
- Reshaping the Ventricle From Within: MIRTH (Myocardial Intramural Remodeling by Transvenous Tether) Ventriculoplasty in Swine.JACC. Basic to translational science · 2023Article
- A Novel Device for Tricuspid Regurgitation Reduction Featuring 3-Dimensional Leaflet and Atraumatic Anchor: Pivot-TR System.JACC. Basic to translational science · 2022Article
- Tricuspid Valve Percutaneous Therapies.Current cardiology reports · 2022Review
- Transcatheter Mitral Cerclage Ventriculoplasty: From Bench to Bedside.JACC. Cardiovascular interventions · 2022Article
- Over 15 years: the advancement of transcatheter mitral valve repair.Annals of cardiothoracic surgery · 2021Review
- What Is the Next Generation of Transcatheter Mitral Valve Repair Devices?Frontiers in cardiovascular medicine · 2021Article
- Septal Reduction Using Transvenous Intramyocardial Cerclage Radiofrequency Ablation: Preclinical Feasibility.JACC. Basic to translational science · 2020Article
- Mitral and Tricuspid Transcatheter Interventions Current Indications and Future Directions.Frontiers in cardiovascular medicine · 2020Review
- Update on the Current Landscape of Transcatheter Options for Tricuspid Regurgitation Treatment.Interventional cardiology (London, England) · 2019Review
- The unique mechanism of functional mitral regurgitation in acute myocardial infarction: a prospective dynamic 4D quantitative echocardiographic study.European heart journal. Cardiovascular Imaging · 2019Article
- Percutaneous Mitral Valve Interventions (Repair): Current Indications and Future Perspectives.Frontiers in cardiovascular medicine · 2019Review
- Emerging Technologies for Percutaneous Mitral Valve Repair.Frontiers in cardiovascular medicine · 2019Review
- Indirect Annuloplasty to Treat Functional Mitral Regurgitation: Current Results and Future Perspectives.Frontiers in cardiovascular medicine · 2019Review
- Computational analysis of the electromechanical performance of mitral valve cerclage annuloplasty using a patient-specific ventricular model.The Korean journal of physiology & pharmacology : official journal of the Korean Physiological Society and the Korean Society of Pharmacology · 2019Article
Corrections and comments
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Authors and funding
14 authors at 3 institutions in 2 countries.
Funding
Abstract
objectivesThis is an early feasibility clinical test of mitral loop cerclage annuloplasty to treat secondary mitral valve regurgitation.
backgroundSecondary mitral regurgitation is characterized by cardiomyopathy, mitral annular enlargement, and leaflet traction contributing to malcoaptation. Transcatheter mitral loop cerclage applies circumferential compression to the mitral annulus by creating a loop through the coronary sinus across the interventricular septum, protecting entrapped coronary arteries from compression, and interactive annular reduction under echocardiographic guidance. This is the first human test of mitral loop annuloplasty.
methodsFive subjects with severe symptomatic secondary mitral regurgitation underwent mitral loop cerclage, with echocardiographic and computed tomography follow-up over 6 months.
resultsMitral loop cerclage was successful in 4 of 5 subjects and aborted in 1 of the 5 because of unsuitable septal coronary vein anatomy. Immediately and over 6 months, measures of both mitral valve regurgitation (effective orifice area and regurgitation fraction) and chamber dimensions (left atrial and left ventricular volumes) were reduced progressively and ejection fractions increased. Two with persistent and permanent atrial fibrillation spontaneously reverted to sinus rhythm during follow-up. One subject experienced a small myocardial infarction from an unrecognized small branch coronary occlusion. Another, experiencing cardiogenic shock at baseline, died of intractable heart failure after 6 weeks.
conclusionsIn this first human test, mitral loop cerclage annuloplasty was successful in 4 of 5 attempts, caused reverse remodeling (reduction in secondary mitral regurgitation and heart chamber volumes), and suggested electrical remodeling (reversion of atrial fibrillation). Further evaluation is warranted.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.