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Riparazione della valvola mitrale percutanea o chirurgica (PRIMARY)

23 ottobre 2026 aggiornato da: Annetine Gelijns

Riparazione percutanea o chirurgica nel prolasso mitralico e rigurgito per ≥65 anni (PRIMARIO)

This is a prospective, multicenter, open-label, randomized trial comparing mitral valve (MV) transcatheter edge-to-edge repair (TEER) to surgical repair (1:1 ratio) in patients with primary, degenerative mitral regurgitation (MR). The trial will be conducted in the U.S., Canada, Germany, Spain, and the United Kingdom, and is designed as a strategy trial. Thus, all devices legally marketed for TEER of primary degenerative MR in a particular country are eligible to be used in this trial.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The primary aim of this study is to evaluate the long-term effectiveness and safety of MV TEER compared with surgical repair in patients with primary, degenerative MR. The secondary aim is to analyze the relationship between the adequacy of MR correction at one-year post intervention and longer-term clinical outcomes (death, heart failure hospitalizations/urgent care visits, valve re-interventions, and quality of life). The tertiary aim of this trial is to evaluate a range of patient-centered outcomes (quality of life, functional status, and discharge location) of transcatheter edge-to-edge MV repair compared with MV surgical repair in patients with primary, degenerative mitral regurgitation. This study is closely integrated with the PRIMARY Ancillary Substudy (NCT07103733)

The patient population for this trial consists of adult patients with severe, primary degenerative MR for whom the local heart team has verified that an indication for MV intervention is present and for whom both transcatheter edge-to-edge and surgical repair strategies are anatomically feasible.

Because the use of the commercial edge-to-edge mitral repair device in the U.S. is approved only in patients considered to be at prohibitive risk of MV surgery by a heart team, use of such devices in this trial is considered investigational by the FDA. As such, this trial will be conducted under an Investigational Device Exemption (IDE).

Outcomes will be measured from randomization over a period of 5 years post intervention. The estimated enrollment period is 36 months, and all patients will be followed from randomization for up to 10 years post intervention for particular endpoints. Long-term follow-up will include leveraging administrative datasets linked to clinical trial data.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

450

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.

Luoghi di studio

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, BC V6E 1M7
        • University of British Columbia, Providence Health Care, St. Paul's Hospital
    • Ontario
      • London, Ontario, Canada, ON N6A 5W9
        • London Health Sciences
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute
      • Toronto, Ontario, Canada, M5B 1W8St
        • Unity Health Toronto (St. Michael's Hospital)
    • Quebec
      • Québec, Quebec, Canada, QC G1V 4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (Laval University)
  • Germania
      • Bad Nauheim, Germania, 61231
        • Kerckhoff Klinik Bad Nauheim
      • Bad Rothenfelde, Germania, 49214
        • Schüchtermann-Klinik Bad Rothenfelde
      • Berlin, Germania, 13353
        • Deutsches Herzzentrum der Charité
      • Frankfurt, Germania, 60590
        • Universitätsklinikum Frankfurt
      • Freiburg im Breisgau, Germania, 79106
        • Universitätsklinikum Freiburg
      • Hamburg, Germania, 20099
        • Asklepios Klinik St. Georg Hamburg
      • Hamburg, Germania, 20246
        • Universitätsklinikum Hamburg Eppendorf
      • Heidelberg, Germania, 69120
        • Universitätsklinikum Heidelberg
      • Jena, Germania, 07747
        • Universitätsklinikum Jena
      • Kiel, Germania, 24105
        • Universitätsklinikum Schleswig-Holstein Campus Kiel
      • Leipzig, Germania, 04289
        • Herzzentrum Leipzig
      • Lübeck, Germania, 23538
        • Universitätsklinikum Schleswig-Holstein Campus Lübeck
      • München, Germania, 80636
        • Deutsches Herzzentrum München
    • Berlin-kölnische Allee
      • Cologne, Berlin-kölnische Allee, Germania, 50969
        • Universitätsklinikum Köln
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germania, 50937
        • Universitätsklinikum Köln
  • Regno Unito
      • Birmingham, Regno Unito, B15 2TH
        • University Hospitals Birmingham NHS Foundation Trust
      • Bristol, Regno Unito, BS1 3NU
        • University Hospital Bristol and Weston NHS Foundation Trust
      • Clydebank, Regno Unito, G81 4DY
        • Golden Jubilee University National Hospital
      • Headington, Regno Unito, OX3 9DU
        • Oxford University Hospitals NHS Foundation Trust
      • London, Regno Unito, E1 8PR
        • Barts Health NHS Trust
      • Middlesbrough, Regno Unito, TS4 3BW
        • South Tees Hospitals NHS Foundation Trust
    • England
      • Cambridge, England, Regno Unito, CB2 0AY
        • Royal Papworth Hospital NHS Foundation Trust
      • Leeds, England, Regno Unito, LS1 3EX
        • The Leeds Teaching Hospitals NHS Trust
      • London, England, Regno Unito, SE5 9RS
        • King's College Hospital NHS Foundation Trust
      • London, England, Regno Unito, SE1 7EH
        • St. Thomas Guy's and St Thomas' NHS Foundation Trust
      • London, England, Regno Unito, SW3 6NP
        • Royal Brompton and Harefield Guy's and St Thomas' NHS Foundation Trust
      • Manchester, England, Regno Unito, M23 9LT
        • Manchester University NHS Foundation Trust
    • West Sussex
      • Worthing, West Sussex, Regno Unito, BN2 5BE
        • University Hospitals Sussex NHS Foundation Trust
  • Spagna
      • Barcelona, Spagna, 08036
        • Hospital Clinic De Barcelona
      • Madrid, Spagna, 28040
        • Hospital Clínico San Carlos
      • Oviedo, Spagna, 33011
        • Hospital Central de Asturias
    • Balearic Islands
      • Palma de Mallorca, Balearic Islands, Spagna, 07120
        • Hospital Universitari Son Espases.
    • Galacia
      • Vigo, Galacia, Spagna, 36204
        • Hospital Alvaro Cunqueiro
  • Stati Uniti
    • California
      • Los Angeles, California, Stati Uniti, 90048
        • Cedars Sinai Medical Center
      • Los Angeles, California, Stati Uniti, 90033
        • Keck Hospital of the University of Southern California
      • San Francisco, California, Stati Uniti, 94143
        • University of California San Francisco
      • Stanford, California, Stati Uniti, 94305
        • Stanford University
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30308
        • Emory University Hospital Midtown
      • Atlanta, Georgia, Stati Uniti, 30322
        • Emory University
      • Atlanta, Georgia, Stati Uniti, 30309
        • Piedmont Heart Institute
    • Louisiana
      • New Orleans, Louisiana, Stati Uniti, 70121
        • Ochsner Clinic
    • Maine
      • Portland, Maine, Stati Uniti, 04102
        • Maine Medical Center
    • Maryland
      • Baltimore, Maryland, Stati Uniti, 21287
        • The Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, Stati Uniti, 02115
        • Brigham and Women's
    • Michigan
      • Ann Arbor, Michigan, Stati Uniti, 48109
        • University of Michigan Hospital
    • Missouri
      • Kansas City, Missouri, Stati Uniti, 64111
        • Saint Luke's Hospital of Kansas City/MidAmerica Heart and Lung Surgeons
    • New Hampshire
      • Lebanon, New Hampshire, Stati Uniti, 03756
        • Dartmouth Hitchcock Medical Center
    • New York
      • Bay Shore, New York, Stati Uniti, 11706
        • Northwell - South Shore
      • Manhasset, New York, Stati Uniti, 11030
        • Northwell Health - North Shore
      • New York, New York, Stati Uniti, 10032
        • New York-Presbyterian/Columbia University Medical Center
      • New York, New York, Stati Uniti, 10075
        • Northwell Health - Lenox Hill
      • New York, New York, Stati Uniti, 10065
        • Weill Cornell Medicine/ New York-Presbyterian Hospital
      • Staten Island, New York, Stati Uniti, 10305
        • Northwell Staten Island University Hospital
    • North Carolina
      • Durham, North Carolina, Stati Uniti, 27710
        • Duke University Hospital
    • Ohio
      • Cleveland, Ohio, Stati Uniti, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • Hospital of the University of Pennsylvania
    • South Carolina
      • Charleston, South Carolina, Stati Uniti, 29425
        • Medical University of South Carolina
    • Texas
      • Dallas, Texas, Stati Uniti, 75246
        • Baylor, Scott and White
    • Virginia
      • Charlottesville, Virginia, Stati Uniti, 22903
        • University of Virginia Medical Center
    • West Virginia
      • Morgantown, West Virginia, Stati Uniti, 26506
        • West Virginia University Hospital

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

60 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

The patient population for this trial consists of adults with severe, primary degenerative MR for whom the local heart team has verified that an indication for MV intervention is present and for whom both transcatheter edge-to-edge and surgical repair strategies are anatomically feasible. Specific inclusion and exclusion criteria are listed below. All patients who meet eligibility criteria will be included in the study regardless of gender, race, or ethnicity.

Inclusion Criteria:

  • Adult patients ≥60 years with moderately-severe or severe (3+ or 4+/4+) primary degenerative (Carpentier type II) MR defined by transthoracic echocardiography
  • Clinical indication for MV intervention and anatomic candidate for both surgical MV repair and transcatheter edge-to-edge repair (TEER) per local heart team assessment with central eligibility committee verification
  • Patients across the surgical risk spectrum (low, intermediate, and high risk) depending on local heart team assessment and central eligibility committee verification (see ACC/AHA 2020 guidelines for the management of patients with valvular heart disease)
  • Patients with AF who meet an indication for a concomitant ablation procedure be included provided the local heart team and central eligibility committee decide they are eligible for both catheter-based and surgical ablation.
  • Ability to perform 6-minute walk test (6MWT) and complete Kansas City Cardiomyopathy Questionnaire (KCCQ) instrument

Exclusion Criteria:

  • Non-degenerative types of primary MR (e.g., cleft leaflet)
  • Secondary or functional MR
  • Hypertrophic obstructive cardiomyopathy
  • Presence of an IVC filter or permanent pacing/ICD leads that would interfere with TEER per local heart team assessment
  • Known allergic reactions to intravenous contrast
  • Febrile illness within 30-days prior to randomization
  • Any absolute contraindication to transesophageal echocardiography
  • Any contraindication to systemic heparinization including active bleeding diatheses, and heparin induced thrombocytopenia
  • Patients with CAD requiring revascularization
  • Any prior mitral valve intervention or any prior repair of atrial septal defect
  • Any prior MV intervention or any prior repair of atrial septal defect
  • Need for any of the following concomitant procedures: aortic valve or aortic surgery, tricuspid valve surgery
  • Need for any emergency intervention or surgery
  • Active endocarditis
  • Hemodynamic instability defined as cardiac index <2.0 l/min/m2 or systolic blood pressure <90mmHg or need for inotropic support or any mechanical circulatory support
  • Left ventricular ejection fraction <25%
  • Intracardiac mass or thrombus
  • Co-morbid medical or oncologic condition for which local heart team believes that survival beyond 2 years is unlikely
  • Active substance abuse
  • Suspected inability to adhere to follow-up
  • Treatment with another investigational drug or other intervention, assessment of which has not completed the primary endpoint or that clinically interferes with the present study endpoints.

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
Comparatore attivo: Surgical mitral valve repair

Patients who are randomized to the surgical arm will undergo mitral surgery.
Procedura: Mitral valve repair

Patients who are randomized to the surgical arm will undergo mitral surgery. Mitral surgery will be conducted using general anesthesia and cardiopulmonary bypass. Mitral surgery may be performed via a sternotomy or a right thoracotomy approach with or without robotic assistance. Standard techniques commonly include a ring or band annuloplasty to correct and prevent annular dilatation; leaflet prolapse and redundancy may be corrected by leaflet resection techniques and / or chordal reconstruction.

Altri nomi:
  • Chirurgia della valvola mitrale
Comparatore attivo: Transcatheter edge-to-edge repair

In the transcatheter edge-to-edge repair arm, patients will be treated with a commercially-approved edge-to-edge mitral repair device.
Dispositivo: Transcatheter edge-to-edge repair

Patients will be treated with a commercially-approved edge-to-edge mitral repair device. The steerable guide catheter (guide) is inserted into the femoral vein and advanced across the inter-atrial septum using image guided puncture. Fluoroscopic and echocardiographic guidance will be used to visualize the devices and assess the repair. The guide is positioned over the MV and the clip/clasp delivery system is inserted into the guide and positioned over the MV in accordance with the manufacturer's instructions. The delivery catheter is advanced until the clip/clasp emerges from the tip of the guide into the left atrium. The catheter is manipulated using the control handle until the clip/clasp is correctly oriented with respect to the line of coaptation of the mitral valve. The clip/clasp is opened, and advanced across the mitral valve into the left ventricle then pulled back to grasp the leaflets.

Altri nomi:
  • TEER

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
All-cause mortality, valve re-intervention, hospitalizations and urgent visits for heart failure, or onset of ≥ 2+ MR (by transthoracic echocardiogram (TTE)) composite score.
Lasso di tempo: 3 years post intervention

All-cause mortality, valve re-intervention, hospitalizations/urgent visits for heart failure (without a blanking period), or onset of ≥ 2+ MR (by transthoracic echocardiogram (TTE)) from randomization to a minimum of 3 years post intervention.

Composite score will be expressed as a Z-score - The Z-Score is a statistical measurement of a score's relationship to the mean in a group of scores. A Z-score of 0 is equal to the mean, with negative numbers indicating values lower than the mean and positive values higher than the mean.
3 years post intervention

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Adequacy of MR correction
Lasso di tempo: one year post intervention

Adequacy of MR correction at one year post intervention, defined as < 2+ MR as assessed by TTE
one year post intervention
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Lasso di tempo: up to 10 years post intervention

Disease-specific quality of life as measured by the KCCQ at 6-month time intervals up to 5 years. KCCQ has 23 items that map to 7 domains: symptom frequency; symptom burden; symptom stability; physical limitations; social limitations; quality of life; and self-efficacy. The symptom frequency and symptom burden domains are merged into a total symptom score, which can be combined with the physical limitation domain to create a clinical summary score. All scores are scaled 0 to 100, with higher scores indicating better health outcome.
up to 10 years post intervention
Procedure failure
Lasso di tempo: End of procedure

Procedure failure defined as residual moderately severe or severe (3+ or 4+/4+) MR at the end of the procedure, or conversion of a TEER to an open surgical repair or replacement, or conversion of a surgical mitral valve repair to a mitral valve replacement procedure.
End of procedure
Procedure failure
Lasso di tempo: 10 years post randomization

Procedure failure defined as residual moderately severe or severe (3+ or 4+/4+) MR at the end of the procedure, or conversion of a TEER to an open surgical repair or replacement, or conversion of a surgical mitral valve repair to a mitral valve replacement procedure.
10 years post randomization
All-cause mortality
Lasso di tempo: 5 years post randomization

All-cause mortality through 5 years post randomization
5 years post randomization
All-cause mortality
Lasso di tempo: 10 years post intervention

All-cause mortality from randomization through 10 years post intervention
10 years post intervention
Cardiovascular and non-cardiovascular mortality
Lasso di tempo: 5 years post intervention

Cardiovascular and non-cardiovascular mortality from randomization through 5 years post intervention
5 years post intervention
Cardiovascular and non-cardiovascular mortality
Lasso di tempo: 10 years post intervention

Cardiovascular and non-cardiovascular mortality from randomization through 10 years post intervention
10 years post intervention
Valve re-interventions
Lasso di tempo: 5 years post intervention

Valve re-interventions through 5 years post intervention
5 years post intervention
Valve re-interventions
Lasso di tempo: 10 years post intervention

Valve re-interventions through 10 years post intervention
10 years post intervention
Serious or protocol-defined adverse events
Lasso di tempo: 5 years post intervention

Serious or protocol-defined adverse events, including stroke, acute kidney injury (AKI), and renal failure, through 5 years
5 years post intervention
MR grade
Lasso di tempo: up to 6 years post intervention

Mitral Regurgitation (MR) grade as mild, moderate, or severe. (grade I-IV, with higher grade indicating poorer health outcomes.)
up to 6 years post intervention
Left Ventricular Ejection Fraction (LVEF)
Lasso di tempo: up to 6 years post intervention

Left ventricular ejection fraction (LVEF) is the measurement of how much blood is being pumped out of the left ventricle of the heart (the main pumping chamber) with each contraction.
up to 6 years post intervention
Left Ventricular End Diastolic Dimension (LVEDD)
Lasso di tempo: up to 6 years post intervention

Left ventricular end diastolic dimension (LVEDD) is the diameter across the left ventricle of the heart at the end of diastole, that is, when the heart muscle is maximally relaxed, and usually corresponds to its largest diameter.
up to 6 years post intervention
Left Ventricular End Systolic Dimension (LVESD)
Lasso di tempo: up to 6 years post intervention

Left ventricular end systolic dimension (LVESD) is the diameter across the left ventricle of the heart at the end of systole, that is, when the heart muscle is maximally contracted, and usually corresponds to its smallest diameter.
up to 6 years post intervention
Left Ventricular End Diastolic Volume (LVEDV)
Lasso di tempo: up to 6 years post intervention

Left Ventricular end diastolic volume (LVEDV) is the volume of blood in the left ventricle at the end of the diastole or ventricular filling.
up to 6 years post intervention
Left Ventricular End Systolic Volume (LVESV)
Lasso di tempo: up to 6 years post intervention

Left Ventricular end systolic volume (LVESV) is the volume of blood in the left ventricle at the end of the systolic ejection phase immediately before the beginning of diastole or ventricular filling.
up to 6 years post intervention
Mitral valve gradient
Lasso di tempo: up to 6 years post intervention

The valve gradient is the difference in pressure on each side of the valve. When a valve is narrowed (a condition called stenosis), the pressure on the front of the valve builds up as blood is forced through the narrow opening. This causes a larger pressure difference between the front and back of the valve. The valve gradient can be used to determine the severity of the valve disorder.
up to 6 years post intervention
Forward stroke volume
Lasso di tempo: up to 6 years post intervention

The forward stroke volume is the volume entering the aorta.
up to 6 years post intervention
6 Minute Walk Test (6MWT)
Lasso di tempo: up to 5 years post intervention

Functional status as measured by the 6MWT at yearly time intervals over 5 years. 6MT - The distance covered over a time of 6 minutes
up to 5 years post intervention
EuroQol- 5 Dimension (EQ-5D)
Lasso di tempo: through 10 years post intervention

Generic QoL as measured by the EuroQol-5D (EQ-5D). The EQ-5D descriptive system is a preference-based HRQL measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The answers given to ED-5D permit to find 243 unique health states or can be converted into EQ- 5D index an utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a grade ranging from 0 (the worst possible health status) to 100 (the best possible health status).
through 10 years post intervention
Length of stay (LOS)
Lasso di tempo: through 10 years post intervention

Length of stay as measured by number of days hospitalized.
through 10 years post intervention
ICU days of index hospitalization
Lasso di tempo: through 10 years post intervention

Number of ICU days of index hospitalization
through 10 years post intervention
Number and reasons for readmissions
Lasso di tempo: through 10 years post intervention

Number and reasons for readmissions, including for valve re-intervention and readmissions/urgent visits for heart failure
through 10 years post intervention
Cost
Lasso di tempo: through 10 years post intervention

Costs associated with the index hospitalization as well as follow-up readmissions will be measured.
through 10 years post intervention
Cost-effectiveness
Lasso di tempo: through 10 years post intervention

A cost-effectiveness analysis (CEA) comparing cumulative costs and quality-adjusted life years (QALYs) of transcatheter edge-to-edge repair vs surgical repair will be performed from U.S., Canadian, German and United Kingdom health care sector perspectives according to national guidelines.
through 10 years post intervention
Number of participants with stroke with disability
Lasso di tempo: 30 days post-intervention

Stroke with disability is defined as a modified Rankin score of ≥ 2 and/or major bleeding (BARC Type 3b, 3c and 5) by 30 days post-intervention
30 days post-intervention

Collaboratori e investigatori

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

Sponsor

Annetine Gelijns

Collaboratori

National Heart, Lung, and Blood Institute (NHLBI)

Investigatori

  • Direttore dello studio: Martin Leon, MD, Columbia University
  • Direttore dello studio: Patrick O'Gara, MD, Brigham and Women's Hospital
  • Direttore dello studio: Joanna Chikwe, MD, Cedars Sinai

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Collegamenti utili

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 (Effettivo)

21 febbraio 2022

Completamento primario (Stimato)

30 giugno 2029

Completamento dello studio (Stimato)

31 gennaio 2034

Date di iscrizione allo studio

Primo inviato

10 settembre 2021

Primo inviato che soddisfa i criteri di controllo qualità

10 settembre 2021

Primo Inserito (Effettivo)

21 settembre 2021

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

23 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STUDY-21-01246
  • 5U01HL088942 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

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

SÌ

Descrizione del piano IPD

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Periodo di condivisione IPD

De-identified study data sets must be submitted to the designated NHLBI Program Official no later than 3 years after the end of the clinical activity (final patient follow-up, etc.) or 2 years after the main paper of the trial has been published, whichever comes first. Data are prepared by the study coordinating center and sent to the designated PO for review prior to release.

Criteri di accesso alla condivisione IPD

Anyone who wishes to access the data. Any purpose. Data are available indefinitely at link included in the URL field below.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF

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

Sì

prodotto fabbricato ed esportato dagli 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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