Ablation With Transcatheter Edge-to-edge Repair for Atrial Functional Mitral Regurgitation and Atrial Fibrillation (ATTRACTION)
2. august 2026 oppdatert av: Mao Chen
Ablation wiTh TRAnsCatheter Edge-to-edge Repair Versus ablaTION Alone for Atrial Functional Mitral Regurgitation and Atrial Fibrillation (ATTRACTION Study)
This trial is a randomized study for patients with significant atrial functional mitral regurgitation (AFMR) and atrial fibrillation (AF).
The composite endpoint of all-cause mortality, cardiovascular-related hospitalizations, AF recurrence, and quality of life improvement is hypothesized to be superior with the combination of transcatheter edge-to-edge repair (TEER) and catheter ablation, compared with catheter ablation alone.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
Rationale:
The introduction of transcatheter edge-to-edge repair (TEER) for the treatment of functional mitral regurgitation (FMR) has led to a significant reduction in mortality and heart failure hospitalizations. However, the optimal timing and intervention for patients with atrial functional mitral regurgitation (AFMR) have not been evaluated in clinical trials. Published clinical trials, including COAPT, MITRA-FR, and RESHAPE-HF, did not classify functional mitral regurgitation according to ventricular or atrial origin. Concerns regarding the role of atrial fibrillation (AF) as a potential trigger of atrial dilatation and a consequence of atrial remodeling have led to recommendations for rhythm control in selected patients. Given the high incidence of AFMR among patients with persistent AF, successful ablation and maintenance of sinus rhythm may remain challenging. Therefore, concomitant TEER and catheter ablation are hypothesized to provide greater clinical benefit compared with catheter ablation alone.
Aim:
The purpose of this study is to evaluate the efficacy of TEER combined with catheter ablation in patients with significant AFMR and AF, focusing on clinical outcomes and atrial reverse remodeling.
Study design:
Patients with moderate-to-severe or severe AFMR and AF will be enrolled in a randomized, open-label, controlled study. Patients will be randomized in a 1:1 ratio to receive TEER combined with catheter ablation or catheter ablation alone. The study duration is anticipated to include 24 months of enrollment and 12 months of follow-up.
Studietype
Intervensjonell
Registrering (Antatt)
384
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Zhengang Zhao
- Telefonnummer: 86-18980733914
- E-post: zhaozhengang@foxmail.com
Studer Kontakt Backup
- Navn: Lijun Zeng
- Telefonnummer: 86-18810672833
- E-post: zenglijun2019@gmail.com
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Age ≥ 18 years
- Left ventricular ejection fraction ≥ 50%
- Grading of MR: 3+ or 4+ (effective regurgitant orifice area≥30mm2, regurgitant volume ≥45ml)
- Valve morphology: MR originating from the mid portion of the valve; mitral valve area> 4 cm2; Length of posterior leaflet ≥10 mm; Sufficient leaflet tissue for mechanical coaptation: coaptation depth< 11 mm, coaptation length> 2 mm
- Rate control in suspected AF-induced cardiomyopathy (heart rate <80 bpm at rest and <110 bpm during exercise)
- Patients must be willing to comply with all follow-up requirements
Exclusion Criteria:
- Life expectancy< 1 year due to non-cardiac conditions
- Primary mitral regurgitation: valve abnormalities including leaflet tethering from LV dysfunction, intrinsic leaflet pathology (prolapse, flail, calcification, severe thickening), mitral annular calcification (either severe or <severe but extending into the leaflets), and/or any mixed pathology
- Active endocarditis of the mitral valve or rheumatic mitral valve disease
- Hypotension (systolic pressure < 90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
- Severe tricuspid regurgitation; Physical evidence of right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction; Fixed pulmonary artery systolic pressure> 70 mmHg
- Stroke/TIA, TAVR, CRT/ CRT-D/ ICD, cardiac intervention or surgery within 30 days before randomization
- Any prior MV surgery or transcatheter procedure
- Need for any cardiac surgery (other than for MV disease)
- Untreated clinically significant coronary artery disease
- Echocardiographic evidence of intracardiac thrombus
- Active infections requiring current antibiotic therapy
- Patients who cannot tolerate anti-platelet/anticoagulation agents/contrast media
- Pregnancy
- Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with medical therapy) and follow-up visits
- Patient (or legal guardian) unable or unwilling to provide written informed consent before study enrollment
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: TEER+Ablation
Patients will undergo catheter ablation and transcatheter edge to edge repair.
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Participants will undergo catheter ablation for persistent atrial fibrillation followed by transcatheter edge-to-edge repair (TEER) for the treatment of functional mitral regurgitation during the same hospitalization.
TEER will be performed using an approved transcatheter mitral valve repair system to reduce mitral regurgitation severity and improve cardiac function.
Andre navn:
Participants will undergo catheter ablation for persistent atrial fibrillation during the study period.
The procedure will include pulmonary vein isolation with additional ablation strategies as clinically indicated.
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Aktiv komparator: Catheter ablation
Patients will undergo catheter ablation only.
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Participants will undergo catheter ablation for persistent atrial fibrillation during the study period.
The procedure will include pulmonary vein isolation with additional ablation strategies as clinically indicated.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Hierarchical Composite Clinical Endpoint (Win Ratio)
Tidsramme: 12 months
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The primary endpoint is a single hierarchical composite clinical endpoint analyzed by pairwise comparison.
Each participant in the transcatheter edge-to-edge repair (TEER) plus catheter ablation group is compared with each participant in the catheter ablation alone group, in order of clinical priority: all-cause mortality, cumulative cardiovascular-related hospitalization, atrial fibrillation recurrence, and change in quality of life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ).
Each pairwise comparison is resolved at the highest-priority component that differs between the two participants, and results in a single "win," "loss," or "tie."
The treatment effect is summarized as one win ratio, defined as the total number of wins divided by the total number of losses across all pairs, comparing the TEER plus catheter ablation group with the catheter ablation alone group.
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12 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Incidence of 30-day composite safety events
Tidsramme: 30 days
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The composite safety endpoint includes cardiovascular mortality, stroke, myocardial infarction, acute kidney injury, major bleeding, and non-elective cardiovascular surgery for device-related complications within 30 days after the procedure.
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30 days
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Change in mitral regurgitation grade from baseline
Tidsramme: 12 months
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Mitral regurgitation severity will be assessed by transthoracic echocardiography according to an integrated approach recommended by current guidelines.
The outcome will be the proportion of patients achieving mild or less mitral regurgitation (grade ≤2) at 12 months.
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12 months
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Composite of all-cause mortality and cardiovascular-related hospitalization
Tidsramme: 12 months
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The composite endpoint includes all-cause mortality and cardiovascular-related hospitalization within 12 months.
Death events will be identified through follow-up records, and cardiovascular-related hospitalizations will be confirmed by medical record review according to predefined criteria.
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12 months
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Cardiovascular mortality
Tidsramme: 12 months
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Cardiovascular mortality is defined as death caused by cardiovascular causes and will be determined through review of medical records and clinical documentation.
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12 months
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Heart failure hospitalizations
Tidsramme: 12 months
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Heart failure hospitalization is defined as an unplanned admission lasting ≥24 hours due to acute decompensated heart failure, with symptoms, signs, and/or laboratory evidence of heart failure and requiring intravenous or mechanical heart failure therapies.
Events will be identified through medical records and adjudicated according to predefined criteria.
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12 months
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Incidence of stroke or transient ischemic attack
Tidsramme: 12 months
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Stroke and transient ischemic attack events will be identified through clinical assessment, medical records, and neuroimaging findings.
Stroke will be classified as ischemic or hemorrhagic according to clinical diagnosis and imaging evaluation.
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12 months
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Change in left atrial volume index
Tidsramme: 12 months
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Left atrial volume index is assessed by the biplane method of disks and indexed to body surface area.
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12 months
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Change in left atrial reservoir function from baseline
Tidsramme: 12 months
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Left atrial reservoir function will be assessed using speckle-tracking echocardiography, and the change from baseline to 12 months will be evaluated.
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12 months
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Change in severity of tricuspid regurgitation from baseline
Tidsramme: 12 months
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Tricuspid regurgitation severity will be assessed by transthoracic echocardiography using an integrated approach according to current guidelines.
The change in tricuspid regurgitation severity from baseline to 12 months will be evaluated.
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12 months
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Change in NYHA functional classification from baseline
Tidsramme: 12 months
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The New York Heart Association (NYHA) functional class will be assessed by clinical evaluation based on patients' symptoms and limitations during physical activity.
The change from baseline to 12 months will be evaluated.
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12 months
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Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level from baseline
Tidsramme: 12 months
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Plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels will be measured using standard laboratory assays.
The change from baseline to 12 months will be evaluated.
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12 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Obadia JF, Messika-Zeitoun D, Leurent G, Iung B, Bonnet G, Piriou N, Lefevre T, Piot C, Rouleau F, Carrie D, Nejjari M, Ohlmann P, Leclercq F, Saint Etienne C, Teiger E, Leroux L, Karam N, Michel N, Gilard M, Donal E, Trochu JN, Cormier B, Armoiry X, Boutitie F, Maucort-Boulch D, Barnel C, Samson G, Guerin P, Vahanian A, Mewton N; MITRA-FR Investigators. Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation. N Engl J Med. 2018 Dec 13;379(24):2297-2306. doi: 10.1056/NEJMoa1805374. Epub 2018 Aug 27.
- Stone GW, Vahanian AS, Adams DH, Abraham WT, Borer JS, Bax JJ, Schofer J, Cutlip DE, Krucoff MW, Blackstone EH, Genereux P, Mack MJ, Siegel RJ, Grayburn PA, Enriquez-Sarano M, Lancellotti P, Filippatos G, Kappetein AP; Mitral Valve Academic Research Consortium (MVARC). Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 1: clinical trial design principles: A consensus document from the mitral valve academic research consortium. Eur Heart J. 2015 Aug 1;36(29):1851-77. doi: 10.1093/eurheartj/ehv281. Epub 2015 Jul 13.
- Wunderlich NC, Siegel RJ. Peri-interventional echo assessment for the MitraClip procedure. Eur Heart J Cardiovasc Imaging. 2013 Oct;14(10):935-49. doi: 10.1093/ehjci/jet060.
- Farhan S, Silbiger JJ, Halperin JL, Zhang L, Dukkipati SR, Vogel B, Kini A, Sharma S, Lerakis S. Pathophysiology, Echocardiographic Diagnosis, and Treatment of Atrial Functional Mitral Regurgitation: JACC State-of-the-Art Review. J Am Coll Cardiol. 2022 Dec 13;80(24):2314-2330. doi: 10.1016/j.jacc.2022.09.046.
- Stone GW, Abraham WT, Lindenfeld J, Kar S, Grayburn PA, Lim DS, Mishell JM, Whisenant B, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Asch FM, Mack MJ; COAPT Investigators. Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation. N Engl J Med. 2023 Jun 1;388(22):2037-2048. doi: 10.1056/NEJMoa2300213. Epub 2023 Mar 5.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. september 2028
Studiet fullført (Antatt)
1. september 2029
Datoer for studieregistrering
Først innsendt
18. juli 2026
Først innsendt som oppfylte QC-kriteriene
2. august 2026
Først lagt ut (Faktiske)
4. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
4. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2026-286
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