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Gjentatt ablasjon av vedvarende atrieflimmer, inkludert Mitral Isthmus Catheter Ablation, med FARAPULSE Puls Field Ablation System (ReMATCH)

21. oktober 2026 oppdatert av: Boston Scientific Corporation

ReMATCH-studien er en prospektiv, enkeltarms, åpen etikett, multisenterstudie som bruker FARAPULSE PFA-systemet, inkludert FARAWAVE- og FARAPOINT PFA-katetrene

The ReMATCH Study is a prospective, single arm, open label, multi-center, study utilizing the FARAPULSE PFA System, including the FARAWAVE and FARAPOINT PFA Catheters.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

The goal of this study is to evaluate the safety and effectiveness of using the FARAWAVE™ and FARAPOINT™ pulsed field ablation (PFA) catheters for re-treatment of persistent atrial fibrillation (PersAF) after a failed initial procedure.

Studietype

Intervensjonell

Registrering (Antatt)

376

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Australia
      • Melbourne, Australia
        • The Alfred Hospital
    • New South Wales
      • New Lambton Heights, New South Wales, Australia, 606-8507
        • John Hunter Hospital
      • Westmead, New South Wales, Australia, 2145
        • Westmead Hospital
    • Queensland
      • Brisbane, Queensland, Australia, 4001
        • St. Andrew's War Memorial Hospital
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Victorian Heart Hospital
      • Parkville, Victoria, Australia, 3050
        • The Royal Melbourne Hospital
  • Forente stater
    • Alabama
      • Mobile, Alabama, Forente stater, 36607
        • Mobile Infirmary Medical Center
    • Arkansas
      • Jonesboro, Arkansas, Forente stater, 72401
        • Arrhythmia Research Group-Research Facility
    • California
      • Los Angeles, California, Forente stater, 90033
        • University of Southern California Hospital
      • Oxnard, California, Forente stater, 93030
        • St. John's Regional Medical Center
      • Stanford, California, Forente stater, 94305
        • Stanford University Medical Center
    • Colorado
      • Littleton, Colorado, Forente stater, 80120
        • South Denver Cardiology Associates, PC
    • Florida
      • Miami, Florida, Forente stater, 33133
        • HCA Florida Mercy Hospital
      • Naples, Florida, Forente stater, 34102
        • Naples Comprehensive Health
      • Orlando, Florida, Forente stater, 32803
        • AdventHealth Orlando-Hospital
      • Tampa, Florida, Forente stater, 33606
        • Tampa General Hospital
      • Tampa, Florida, Forente stater, 33613
        • AdventHealth Tampa-Hospital
    • Georgia
      • Atlanta, Georgia, Forente stater, 30322
        • Emory University Hospital
      • Macon, Georgia, Forente stater, 32201
        • Atrium Health Navicent The Medical Center
      • Savannah, Georgia, Forente stater, 31404
        • Memorial Health University Medical Center
    • Idaho
      • Boise, Idaho, Forente stater, 83712
        • St. Luke's Boise Medical Center
    • Illinois
      • Oak Lawn, Illinois, Forente stater, 60453
        • Advocate Christ Medical Center-Hospital
    • Maryland
      • Baltimore, Maryland, Forente stater, 21287
        • Johns Hopkins Hospital
    • Massachusetts
      • Boston, Massachusetts, Forente stater, 02114
        • Massachusetts General Hospital
      • Fall River, Massachusetts, Forente stater, 02720
        • Southcoast Physicians Group
    • Michigan
      • Royal Oak, Michigan, Forente stater, 48073
        • William Beaumont Hospital-Hospital
    • New Hampshire
      • Lebanon, New Hampshire, Forente stater, 03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Marlton, New Jersey, Forente stater, 08053
        • Virtua Health Inc.
    • New Mexico
      • Albuquerque, New Mexico, Forente stater, 87102
        • Lovelace Medical Center
    • New York
      • Manhasset, New York, Forente stater, 11030
        • Northwell Health
      • New York, New York, Forente stater, 10065
        • Weill Cornell Medical University
    • Ohio
      • Cincinnati, Ohio, Forente stater, 45242
        • Bethesda North Hospital
      • Columbus, Ohio, Forente stater, 43210
        • Ohio State University Medical Center
    • Oklahoma
      • Tulsa, Oklahoma, Forente stater, 74104
        • Oklahoma Heart Institute
    • South Carolina
      • Charleston, South Carolina, Forente stater, 29406
        • Trident Medical Center
    • Texas
      • Austin, Texas, Forente stater, 78705
        • Texas Cardiac Arrhythmia Research
      • Tyler, Texas, Forente stater, 75701
        • Christus Trinity Mother Frances Health System
    • Utah
      • Salt Lake City, Utah, Forente stater, 84124
        • St. Mark's Hospital
    • Virginia
      • Norfolk, Virginia, Forente stater, 23507
        • Sentara Norfolk General Hospital
  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Veterans General Hospital

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • ≥ 18 years of age, or older if required by local law
  • Single previous endocardial AF ablation procedure for PAF or PersAF that minimally included pulmonary vein isolation
  • Documented (physician's note) diagnosis of PersAF either prior to the subject's Index Procedure OR development of PersAF after the Index Procedure.
  • Documented evidence of symptomatic AF recurrence at least 60 days after the subject's Index Procedure, captured by any regulatory cleared rhythm monitoring device.

OR

  • If diagnosed with PersAF prior to the Index Procedure, documented recurrence of symptomatic AF or atypical AFL at least 60 days after the Index Procedure, captured by any regulatory cleared rhythm monitoring device.
  • Willing and capable of providing informed consent
  • Willing and capable of participating in all follow-up assessments and testing associated with this clinical investigation at an approved clinical investigational center

Exclusion Criteria:

  1. Atrial exclusions - Any of the following atrial conditions:

    a. Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter not available, non-indexed volume >100 ml (physician note or imaging) b. Current atrial myxoma c. Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible) d. Current left atrial thrombus

  2. Cardiovascular exclusions - Any of the following CV conditions:

    1. History of sustained ventricular tachycardia or any ventricular fibrillation

    2. AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes

    3. Current or anticipated implantable cardioverter defibrillator, cardiac resynchronization therapy devices, or implantable loop recorders, other than LUX-Dx. Patients with a pacemaker are permitted; however, pacemaker-dependent patients are excluded.

      Prior interatrial baffle, atrial septal patch, atrial septal defect closure device, patent foramen ovale occluder Left atrial appendage closure devices are excluded, with the exception of WATCHMAN. WATCHMAN is excluded if implanted within 90 days of enrollment

    4. Presence of any of the following:

      • Any prosthetic heart valve, ring or repair

      • Moderate to severe mitral valve stenosis

      • More than moderate mitral regurgitation (>3+)

      • Moderate to severe aortic stenosis

    5. Hypertrophic cardiomyopathy

    6. Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access

    7. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months

    8. Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data.

  3. Any of the following conditions at baseline:

    1. Heart failure associated with NYHA Class III or IV
    2. Documented LVEF < 40% as documented within the previous 12 months
    3. Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg on two (2) BP measurements at baseline assessment not attributable to white coat syndrome per Investigator opinion
    4. Body Mass Index (BMI) >45.0
    5. CHA2DS2-VASc score ≥5

  4. Any of the following events within 90 Days of the Consent Date:

    1. Coronary disease: Myocardial infarction (MI), unstable or Prinzmetal angina or coronary intervention within 90 days of consent or any documented history of severe non-revascularize coronary disease
    2. Cardiac surgery: Any cardiac surgery
    3. Heart failure hospitalization: Heart failure hospitalization
    4. Pericardium: Pericarditis or symptomatic pericardial effusion
    5. GI bleeding: Gastrointestinal bleeding
    6. Neurovascular event: Stroke, TIA, or intracranial bleeding
    7. Thromboembolism: Any active non-neurologic thrombus and/or thromboembolic event
    8. Carotid intervention: Carotid stenting or endarterectomy
    9. Diabetes: Uncontrolled diabetes mellitus or a recorded HgbA1c > 8.0%

  5. Any of the following congenital conditions:

    1. Congenital heart disease: Congenital heart disease with any clinically significant residual anatomic or conduction abnormality
    2. Methemoglobinemia: History of known congenital methemoglobinemia
    3. G6PD deficiency: History of known G6PD deficiency

  6. Any of the following conditions:

    1. Transplantation: Solid organ or hematologic transplant, or currently being evaluated for a transplant
    2. Diaphragmatic abnormality: Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis.

    Pulmonary: Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen d. Renal: Renal insufficiency if an estimated glomerular filtration rate (eGFR) is < 30 mL / min / 1.73 m2, or with any history of renal dialysis or renal transplant e. Malignancy: Active malignancy (other than squamous cell carcinoma) f. Gastrointestinal: Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration g. Infections: Active systemic infection h. Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure i. Nitroglycerin intolerance: Known allergic drug reaction to nitroglycerin (excluding hypotension) j. Hematologic condition: Known coagulopathy or bleeding disorder (e.g. von Willebrand disease, hemophilia) k. Contraindication to anticoagulation: Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation.

    l. Pregnancy: Women of childbearing potential who are pregnant, lactating, not using medical birth control or who are planning to become pregnant during the anticipated study period m. General health conditions: Health conditions that, in the investigator's medical opinion, would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation.

    n. LUX-Dx ICM intolerance: Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted LUX-Dx ICM device o. Participation in another trial: Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the Sponsor to determine eligibility.

    p. Life expectancy: Predicted life expectancy less than one (1) year

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Single Arm Prospective

Repeat Ablation of Persistent Atrial Fibrillation, including Mitral Isthmus Catheter Ablation, with the FARAPULSE Pulsed Field Ablation System.
Enhet: FARAPULSE™ Pulsed Field Ablation System

The FARAPULSE™ Pulsed Field Ablation System is indicated for the treatment of symptomatic atrial fibrillation.

The FARAWAVE Catheter is indicated for the isolation of pulmonary veins and posterior wall in the treatment of drug-refractory, recurrent, symptomatic paroxysmal and persistent atrial fibrillation. The FARAWAVE Catheter is also indicated for the for the isolation of pulmonary veins and posterior wall in the treatment of persistent atrial fibrillation as an alternative to anti-arrhythmic drug (AAD) therapy as an initial rhythm control strategy.

The FARAPOINT™ PFA Catheter is indicated for use as an adjunctive device for 1) the creation of an ablation line between the inferior vena cava and the tricuspid valve and/or 2) Mitral Isthmus, when the FARAWAVE Catheter is used in the endocardial treatment of persistent atrial fibrillation (episode duration no greater than 12 months).

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Primary safety endpoint rate
Tidsramme: 60 days

The primary safety endpoint (PSE) is the proportion of Treatment subjects with one or more device or procedure-related Composite Serious Adverse Events (CSAEs) following the Repeat Ablation Procedure.
60 days
The primary effectiveness endpoint is the proportion of Treatment subjects with Acute Procedural Success.
Tidsramme: 24 hours

The proportion of Treatment Subjects with confirmed electrical block across all anatomical locations ablated with the investigational system only (Acute Procedural Success).
24 hours

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Boston Scientific Corporation

Etterforskere

  • Hovedetterforsker: Moussa Mansour,, MD, Massachusetts General Hospital

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 (Faktiske)

3. juni 2025

Primær fullføring (Antatt)

1. april 2027

Studiet fullført (Antatt)

1. januar 2028

Datoer for studieregistrering

Først innsendt

11. desember 2024

Først innsendt som oppfylte QC-kriteriene

13. desember 2024

Først lagt ut (Faktiske)

16. desember 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • PF313

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Ja

produkt produsert i og eksportert fra USA

Ja

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