Trial reportEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology2024
Safety and efficacy of the DragonFly system for transcatheter valve repair of degenerative mitral regurgitation: one-year results of the DRAGONFLY-DMR trial.
Trial report in EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04734756 (A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Safety and Effectiveness of Dragonfly Transcatheter Mitral Valve Repair System for the Treatment of Degenerative Mitral Regurgitation), which is not on this map. Cited by 18 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Safety and Effectiveness of Dragonfly Transcatheter Mitral Valve Repair System for the Treatment of Degenerative Mitral Regurgitation (DMR) Subjects.
Who cites it
18 citing papers in PubMed, 1 synthesis or guideline pooled it, 17 citations in OpenAlex.
- Guideline
- Transcatheter Edge-to-Edge Repair for Tricuspid Regurgitation: Design and Rationale of the TEER-CHINA Trial.JACC. Asia · 2026Article
- Novel Transcatheter Edge-to-Edge Repair System for Degenerative Mitral Regurgitation: 1-Year Outcomes.JACC. Asia · 2026Article
- Novel Transcatheter Edge-to-Edge Repair System for High-Risk Primary Mitral Regurgitation: 2-Year Pivotal Trial Outcomes.JACC. Asia · 2026Article
- More to Come: What Can We Expect From the Newcomer in Transcatheter Mitral Edge-to-Edge Repair?JACC. Asia · 2026Article
- Prognostic Value of Prolapse Width for Mid-Term Degenerative Mitral Regurgitation Stability After Transcatheter Edge-to-Edge Repair.Echocardiography (Mount Kisco, N.Y.) · 2026Article
- The Expanding Therapeutic Armamentarium for Mitral Regurgitation: Surgical and Transcatheter Interventions.Biomedicines · 2026Review
- CT-Guided Preprocedural Assessment of TEER in Mitral Prolapse: When Calcification Limits TEE.JACC. Case reports · 2026Article
- Review
- Contemporary Transcatheter Approaches to Mitral Regurgitation.Reviews in cardiovascular medicine · 2026Review
- Technological Innovations and Research Frontiers in Interventional Therapy for Mitral Regurgitation.Reviews in cardiovascular medicine · 2026Review
- Transcatheter tricuspid valve treatment: a growing armamentarium of devices.European heart journal supplements : journal of the European Society of Cardiology · 2026Article
- Percutaneous Treatment of Mitral Regurgitation After Failed Mitral Transcatheter Edge-to-Edge Repair.Journal of cardiovascular development and disease · 2025Review
- Design and Rationale of ECHO-CLIP Study: Transcatheter Edge-to-Edge Repair for Mitral Regurgitation Under Solely Transesophageal Echocardiographic Guidance Compared With Fluoroscopic and Transesophageal Echocardiographic Coguidance.Journal of the American Heart Association · 2025Article
- Transcatheter repair for papillary muscle rupture Post-AMI.BMC cardiovascular disorders · 2025Article
- Transcatheter Edge-to-Edge Repair for Tricuspid Regurgitation in Barlow-Type Tricuspid Valve Prolapse Using the DragonFly-T System.JACC. Case reports · 2025Article
- Epidemiology of Valvular Heart Disease in Asia Pacific Region.JACC. Asia · 2025Review
- One-year outcomes with a new mitral edge-to-edge repair device: is mitral TEER about to conquer the world?EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2024Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
35 authors at 18 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSevere degenerative mitral regurgitation (DMR) can cause a poor prognosis if left untreated. For patients considered at prohibitive surgical risk, transcatheter edge-to-edge repair (TEER) has become an accepted alternative therapy. The DragonFly transcatheter valve repair system is an innovative evolution of the mitral TEER device family to treat DMR.
aimsHerein we report on the DRAGONFLY-DMR trial (ClinicalTrials.gov: NCT04734756), which was a prospective, single-arm, multicentre study on the safety and effectiveness of the DragonFly system.
methodsA total of 120 eligible patients with prohibitive surgical risk and DMR ≥3+ were screened by a central eligibility committee for enrolment. The study utilised an independent echocardiography core laboratory and clinical event committee. The primary endpoint was the clinical success rate, which measured freedom from all-cause mortality, mitral valve reintervention, and mitral regurgitation (MR) >2+ at 1-year follow-up.
resultsAt 1 year, the trial successfully achieved its prespecified primary efficacy endpoint, with a clinical success rate of 87.5% (95% confidence interval: 80.1-92.3%). The rates of major adverse events, all-cause mortality, mitral valve reintervention, and heart failure hospitalisation were 9.0%, 5.0%, 0.8%, and 3.4%, respectively. MR ≤2+ was 90.4% at 1 month and 92.0% at 1 year. Over time, left ventricular reverse remodelling was observed (p<0.05), along with significant improvements in the patients' functional and quality-of-life outcomes, shown by an increase in the New York Heart Association Class I/II from 32.4% at baseline to 93.6% at 12 months (p<0.001) and increased Kansas City Cardiomyopathy Questionnaire (KCCQ) score of 31.1±18.2 from baseline to 12 months (p<0.001).
conclusionsThe DRAGONFLY-DMR trial contributes to increasing evidence supporting the safety and efficacy of TEER therapy, specifically the DragonFly system, for treating patients with chronic symptomatic DMR 3+ to 4+ at prohibitive surgical risk.
Indexed as
Identifiers
What OpenQuestion holds
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.