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Ablation With Transcatheter Edge-to-edge Repair for Atrial Functional Mitral Regurgitation and Atrial Fibrillation (ATTRACTION)

2 agosto 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

384

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: TEER+Ablation
Patients will undergo catheter ablation and transcatheter edge to edge repair.
Dispositivo: Transcatheter edge to edge repair
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.
Altri nomi:
  • TEER
Procedura: Catheter ablation
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.
Comparatore attivo: Catheter ablation
Patients will undergo catheter ablation only.
Procedura: Catheter ablation
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Hierarchical Composite Clinical Endpoint (Win Ratio)
Lasso di tempo: 12 months
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.
12 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of 30-day composite safety events
Lasso di tempo: 30 days
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.
30 days
Change in mitral regurgitation grade from baseline
Lasso di tempo: 12 months
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.
12 months
Composite of all-cause mortality and cardiovascular-related hospitalization
Lasso di tempo: 12 months
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.
12 months
Cardiovascular mortality
Lasso di tempo: 12 months
Cardiovascular mortality is defined as death caused by cardiovascular causes and will be determined through review of medical records and clinical documentation.
12 months
Heart failure hospitalizations
Lasso di tempo: 12 months
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.
12 months
Incidence of stroke or transient ischemic attack
Lasso di tempo: 12 months
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.
12 months
Change in left atrial volume index
Lasso di tempo: 12 months
Left atrial volume index is assessed by the biplane method of disks and indexed to body surface area.
12 months
Change in left atrial reservoir function from baseline
Lasso di tempo: 12 months
Left atrial reservoir function will be assessed using speckle-tracking echocardiography, and the change from baseline to 12 months will be evaluated.
12 months
Change in severity of tricuspid regurgitation from baseline
Lasso di tempo: 12 months
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.
12 months
Change in NYHA functional classification from baseline
Lasso di tempo: 12 months
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.
12 months
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level from baseline
Lasso di tempo: 12 months
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.
12 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Mao Chen

Collaboratori

Abbott

Investigatori

  • Investigatore principale: Mao Chen, West China Hospital

Pubblicazioni e link utili

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Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 settembre 2028

Completamento dello studio (Stimato)

1 settembre 2029

Date di iscrizione allo studio

Primo inviato

18 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

2 agosto 2026

Primo Inserito (Effettivo)

4 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 agosto 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 agosto 2026

Ultimo verificato

1 agosto 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026-286

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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