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Irrigated Ablation System Evaluation for Atrial Fibrillation (AF) (IRASE-AF)

1. februar 2019 opdateret af: Abbott Medical Devices

Irrigated Ablation System Evaluation for AF

The purpose of this study is to test the safety and effectiveness of an Irrigated Ablation System for the treatment of symptomatic paroxysmal atrial fibrillation.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

324

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunybrook Health Sciences Centre
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85251
        • Arizona Arrhythmia Consultants/Scottsdale Healthcare
    • California
      • Los Angeles, California, Forenede Stater, 90017
        • Good Samaritan Hospital
      • San Diego, California, Forenede Stater, 92037
        • University of Californai, San Diego Medical Center
    • Colorado
      • Colorado Springs, Colorado, Forenede Stater, 80907
        • Colorado Cardiac Alliance
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32204
        • Diagnostic Cardiology Associates, P.A.; St. Vincents Medical Center
      • Tampa, Florida, Forenede Stater, 33606
        • Tampa General Hospital
    • Georgia
      • Emory, Georgia, Forenede Stater, 30308
        • Emory University Hospital, Midtown
    • Kansas
      • Kansas City, Kansas, Forenede Stater, 66160
        • University of Kansas Hospital
    • Maryland
      • Takoma Park, Maryland, Forenede Stater, 20912
        • Washington Adventist Hospital
    • Michigan
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Spectrum Health
    • Missouri
      • Kansas City, Missouri, Forenede Stater, 64111
        • MAHI, Saint Luke's Hospital
    • New York
      • New York, New York, Forenede Stater, 10029
        • Mount Sinai Hospital
      • New York, New York, Forenede Stater, 10016
        • NYU Langone Medical Center
      • Rochester, New York, Forenede Stater, 14642
        • University of Rochester
    • Ohio
      • Cleveland, Ohio, Forenede Stater, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, Forenede Stater, 44106
        • University Hospitals Case Medical Center
      • Columbus, Ohio, Forenede Stater, 43210
        • The Ohio State University Medical Center
    • Pennsylvania
      • Doylestown, Pennsylvania, Forenede Stater, 18901
        • Doylestown Hospital
      • Philadelphia, Pennsylvania, Forenede Stater, 19104
        • Hospital of the University of Pennsylvania
    • Tennessee
      • Nashville, Tennessee, Forenede Stater, 37203
        • Centennial Medical Center
    • Texas
      • Austin, Texas, Forenede Stater, 78746
        • Texas Cardiac Arrhythmia Research Foundation
      • Dallas, Texas, Forenede Stater, 75226
        • Baylor Heart & Vascular Hospital
      • Houston, Texas, Forenede Stater, 77030
        • The Methodist Hospital Research Institute
    • Utah
      • Salt Lake City, Utah, Forenede Stater, 84157
        • Intermountain Medical Center
    • Virginia
      • Charlottesville, Virginia, Forenede Stater, 22908
        • University of Virginia Health System
      • Falls Church, Virginia, Forenede Stater, 22042
        • Inova Fairfax Hospital / Inova Heart and Vascular Institute
  • Korea, Republikken
      • Seoul, Korea, Republikken, 120-752
        • Severance Hospital
      • Seoul, Korea, Republikken, 136-705
        • Korea University Anam Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Age 18 years or older
  • Signed Patient Informed Consent Form
  • Able and willing to comply with all pre-, post-, and follow-up testing and requirements
  • Failure of at least one anti-arrhythmic medication (AAD) for paroxysmal atrial fibrillation* [class I or III, or AV nodal blocking agents such as beta blockers (BB) and calcium channel blockers (CCB)] as evidenced by recurrent symptomatic paroxysmal atrial fibrillation*, or intolerable side effects due to AAD

  • Subjects with symptomatic paroxysmal atrial fibrillation (PAF)*

    • PAF is defined as recurrent atrial fibrillation (AF) that terminates spontaneously within seven days.

Exclusion Criteria:

  • Atrial fibrillation (AF) secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
  • Previous ablation for AF
  • History of any valvular cardiac surgical procedure
  • Coronary artery bypass grafting (CABG) procedure within the last six months
  • Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
  • Left atrial thrombus
  • History of a documented thromboembolic event within the past one (1) year
  • Diagnosed atrial myxoma
  • An implanted implantable cardioverter defibrillator (ICD)
  • Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms
  • Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
  • Women who are pregnant (by history of menstrual period or pregnancy test if the history is considered unreliable)
  • Acute illness or active systemic infection or sepsis
  • Unstable angina
  • Myocardial infarction within the previous two months
  • Left ventricular ejection fraction (LVEF) <40% as determined by pre-procedure transthoracic echocardiogram (TTE)
  • History of blood clotting or bleeding abnormalities
  • Contraindication to anticoagulation (i.e. heparin or warfarin)
  • Contraindication to computed tomography/magnetic resonance angiography (CT/MRA) procedure
  • Life expectancy less than 12 months
  • Enrollment in an investigational study evaluating another device or drug
  • Uncontrolled heart failure or New York Heart Association (NYHA) class III or IV heart failure
  • An intramural thrombus tumor, or other abnormality that precludes catheter introduction or manipulation
  • Presence of a condition that precludes vascular access
  • Left atrial size ≥ 50 mm as determined by pre-procedure TTE

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: St. Jude Medical Cardiac Ablation System
Enhed: SJM Irrigated Cardiac Ablation System
Irrigated ablation catheter
Aktiv komparator: FDA approved Open Irrigated Radio Frequency Ablation System
Enhed: FDA approved Open Irrigated RF Ablation System
Irrigated ablation catheter

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Confirmation of Entrance Block in the Pulmonary Veins
Tidsramme: 20 minutes after initial isolation
20 minutes after initial isolation
Incidence of Adverse Events Included in the Pre-specified Composite
Tidsramme: 7 days
Atrial perforation, atrio-esophageal fistula, cardiac tamponade, cerebrovascular accident, death, diaphragmatic paralysis, hospitalization, myocardial infarction, pericaridal effusion, pericarditis, pulumonary edema, pulmonary vein stenosis, thromboembolism, transient ischemic attack, and vascular access complications.
7 days
Incidence of Adverse Events Included in the Pre-specified Composite.
Tidsramme: 12 months
12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period
Tidsramme: 12 months
12 months
Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs
Tidsramme: 12 months
Early onset (within 90 days) of Serious Adverse Events (SAE)/Non-serious Adverse Events (AEs) and late onset (after 90 days) Serious Adverse Events (SAEs)
12 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Abbott Medical Devices

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2010

Primær færdiggørelse (Faktiske)

1. januar 2013

Studieafslutning (Faktiske)

1. januar 2013

Datoer for studieregistrering

Først indsendt

22. januar 2010

Først indsendt, der opfyldte QC-kriterier

22. januar 2010

Først opslået (Skøn)

26. januar 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

26. februar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. februar 2019

Sidst verificeret

1. februar 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 90030928

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Paroksysmal atrieflimren

Kliniske forsøg med SJM Irrigated Cardiac Ablation System

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Israel

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner