Irrigated Ablation System Evaluation for Atrial Fibrillation (AF) (IRASE-AF)
1. februar 2019 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
324
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Ontario
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Toronto, Ontario, Canada, M4N 3M5
- Sunybrook Health Sciences Centre
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Alabama
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Birmingham, Alabama, Forente stater, 35294
- University of Alabama at Birmingham
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Arizona
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Scottsdale, Arizona, Forente stater, 85251
- Arizona Arrhythmia Consultants/Scottsdale Healthcare
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California
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Los Angeles, California, Forente stater, 90017
- Good Samaritan Hospital
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San Diego, California, Forente stater, 92037
- University of Californai, San Diego Medical Center
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Colorado
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Colorado Springs, Colorado, Forente stater, 80907
- Colorado Cardiac Alliance
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Florida
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Jacksonville, Florida, Forente stater, 32204
- Diagnostic Cardiology Associates, P.A.; St. Vincents Medical Center
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Tampa, Florida, Forente stater, 33606
- Tampa General Hospital
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Georgia
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Emory, Georgia, Forente stater, 30308
- Emory University Hospital, Midtown
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Kansas
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Kansas City, Kansas, Forente stater, 66160
- University of Kansas Hospital
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Maryland
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Takoma Park, Maryland, Forente stater, 20912
- Washington Adventist Hospital
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Michigan
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Grand Rapids, Michigan, Forente stater, 49503
- Spectrum Health
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Missouri
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Kansas City, Missouri, Forente stater, 64111
- MAHI, Saint Luke's Hospital
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New York
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New York, New York, Forente stater, 10029
- Mount Sinai Hospital
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New York, New York, Forente stater, 10016
- NYU Langone Medical Center
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Rochester, New York, Forente stater, 14642
- University of Rochester
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Ohio
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Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic
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Cleveland, Ohio, Forente stater, 44106
- University Hospitals Case Medical Center
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Columbus, Ohio, Forente stater, 43210
- The Ohio State University Medical Center
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Pennsylvania
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Doylestown, Pennsylvania, Forente stater, 18901
- Doylestown Hospital
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Philadelphia, Pennsylvania, Forente stater, 19104
- Hospital of the University of Pennsylvania
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Tennessee
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Nashville, Tennessee, Forente stater, 37203
- Centennial Medical Center
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Texas
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Austin, Texas, Forente stater, 78746
- Texas Cardiac Arrhythmia Research Foundation
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Dallas, Texas, Forente stater, 75226
- Baylor Heart & Vascular Hospital
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Houston, Texas, Forente stater, 77030
- The Methodist Hospital Research Institute
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Utah
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Salt Lake City, Utah, Forente stater, 84157
- Intermountain Medical Center
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Virginia
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Charlottesville, Virginia, Forente stater, 22908
- University of Virginia Health System
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Falls Church, Virginia, Forente stater, 22042
- Inova Fairfax Hospital / Inova Heart and Vascular Institute
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Seoul, Korea, Republikken, 120-752
- Severance Hospital
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Seoul, Korea, Republikken, 136-705
- Korea University Anam Hospital
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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:
- 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
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: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: St. Jude Medical Cardiac Ablation System
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Irrigated ablation catheter
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Aktiv komparator: FDA approved Open Irrigated Radio Frequency Ablation System
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Irrigated ablation catheter
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Confirmation of Entrance Block in the Pulmonary Veins
Tidsramme: 20 minutes after initial isolation
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20 minutes after initial isolation
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Incidence of Adverse Events Included in the Pre-specified Composite
Tidsramme: 7 days
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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.
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7 days
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Incidence of Adverse Events Included in the Pre-specified Composite.
Tidsramme: 12 months
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12 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Documented (> 30 Seconds) Asymptomatic Episodes of Atrial Fibrillation (AF), Atrial Flutter (AFL), or Atrial Tachicardia (AT) After the Blanking Period
Tidsramme: 12 months
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12 months
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Early Onset (Within 90 Days) of SAE/Non-serious AEs and Late Onset (After 90 Days) SAEs
Tidsramme: 12 months
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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)
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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.
Sponsor
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
1. februar 2010
Primær fullføring (Faktiske)
1. januar 2013
Studiet fullført (Faktiske)
1. januar 2013
Datoer for studieregistrering
Først innsendt
22. januar 2010
Først innsendt som oppfylte QC-kriteriene
22. januar 2010
Først lagt ut (Anslag)
26. januar 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
26. februar 2019
Siste oppdatering sendt inn som oppfylte QC-kriteriene
1. februar 2019
Sist bekreftet
1. februar 2019
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 90030928
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