European CURE-AF Study
20. november 2020 opdateret af: Medtronic Cardiovascular
European CURE-AF Study - Concomitant Utilization of Radiofrequency Energy for Atrial Fibrillation
A prospective, non-randomized, multi-center clinical trial.
The patient population includes patients with permanent or persistent AF requiring valve replacements or repairs, ASD repairs, PFO closure or coronary artery bypass grafts (CABG) procedures.
Patients are not allowed to have had previous atrial ablation, AV-nodal ablation, or surgical Maze procedure.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The Cardioblate Surgical Ablation System is cleared in Canada and Europe for ablation of cardiac tissue for the treatment of cardiac arrhythmias.
In the United States, the Cardioblate bipolar is approved for soft tissue ablation, while the Cardioblate Pen is approved for cardiac tissue ablation.
The purpose of the clinical study is to obtain a labeling claim for the US market that the Cardioblate Surgical Ablation System can be used for ablation of cardiac tissue in the treatment of cardiac arrhythmias such as atrial fibrillation among permanent and persistent AF patients.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
26
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Hans Nissens Gate 3
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Trondheim, Hans Nissens Gate 3, Norge, 7018
- St. Elizabeth Heart Center - Department of Cardiothoracic Surgery
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Jonas Liesvei 65
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Bergen, Jonas Liesvei 65, Norge, 5021
- Haukeland University Hospital - Department of Cardiothoracic Surgery
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Ul. Banacha 1a
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Warsaw, Ul. Banacha 1a, Polen, 02-097
- Public Central Teaching Hospital - Department of Cardiac Surgery
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Beneke Str. 2-8
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Bad Nauheim, Beneke Str. 2-8, Tyskland, 61231
- Kerckhoff Clinic - Department of Thoracic & Cardiovascular Surgery
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Leipziger Strasse 50
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Cottbus, Leipziger Strasse 50, Tyskland, 03048
- Heart Center Cottbus - Department of Cardiac Surgery
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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:
Patients must meet all of the following criteria to be enrolled in the study:
- Documented history of AF a For inclusion in permanent AF arm: Patients must have a documented history of permanent AF (cardioversion failure) as defined by the ACC/AHA/ESC Guidelines; Documentation of AF must include one or more chart references to AF and/or one or more ECG's with AF prior to the patient's surgery. Other supporting information could include references to cardioversion attempts using either drugs or electrical shock. b For inclusion in persistent AF arm: Patients must have a documented history of persistent AF as defined by the ACC/AHA/ESC Guidelines: characterized as episodes of non-self-terminating atrial fibrillation that usually lasts more than 7 days
- Concomitant indication (other than AF) for open-heart surgery for one or more of the following:
a Mitral valve repair or replacement, b Aortic valve repair or replacement, c Tricuspid valve repair or replacement, d ASD repair, e PFO closure, or f CABG procedures; 3 Able to take the anticoagulant warfarin or other ACC/AHA/ESC-recommended anticoagulant medication; 4 Greater than or equal to 18 years of age; 5 Able and willing to comply with study requirements by signing a Patient Informed Consent form.
Exclusion Criteria:
Patients who meet any of the following criteria may not be enrolled in the study:
1 Wolff-Parkinson-White syndrome, 2 NYHA functional class = IV, 3 Left ventricular ejection fraction ≤ 30%, 4 Left atrial diameter > 7.0 cm, 5. Need for emergent cardiac surgery (i.e. cardiogenic shock) or redo open heart surgery, 6 Preoperative need for an intra-aortic balloon pump or intravenous inotropes, 7 Previous atrial ablation, AV-nodal ablation, or surgical Maze procedure, 8 Contraindication for anticoagulation therapy, 9 Current diagnosis of active systemic infection, 10 Renal failure requiring dialysis or hepatic failure, 11 Documented myocardial infarction 6 weeks prior to study enrollment, 12 Life expectancy of less than one year, or 13 Pregnancy or desire to be pregnant within 12-months of the study treatment.
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: CURE AF
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Denne undersøgelse er et prospektivt, ikke-randomiseret klinisk multicenterforsøg, der evaluerer resultatet af patienter med AF, der kræver samtidig åben hjertekirurgi plus Cardioblate Surgical Ablation System ved hjælp af den modificerede Maze III-procedure.
Forsøgspopulationen omfatter patienter, der har behov for klapudskiftninger eller reparationer, reparationer af atrial septal defekt (ASD), patenteret foramen ovale (PFO) lukning eller koronararterie-bypass-operationer (CABG).
This investigation is a prospective, non-randomized multicenter clinical trial evaluating the outcome of patients with AF requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure.
The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass grafts (CABG) procedures.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Permanent AF Arm
Tidsramme: 24-hour Holter recording at 6 months follow-up
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Primary efficacy endpoint- The percent of patients free of AF, off Class I or III antiarrhythmic drugs and not having received additional ablation therapy, as determined by a 24-hour Holter recording at 6 months follow-up.
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24-hour Holter recording at 6 months follow-up
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Persistent AF Arm
Tidsramme: 24-hour Holter recording at 9 months follow-up.
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The percent of patients free of AF, off Class I or III antiarrhythmic drugs and not having received additional ablation therapy, as determined by a 24-hour Holter recording at 9 months follow-up.
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24-hour Holter recording at 9 months follow-up.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Permanent AF Arm
Tidsramme: 24 hours
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Secondary efficacy endpoints - 24-hour Holter recording, b) improvement in left ventricular ejection fraction and c) left atrial transport function as evidenced by the presence of an A wave at 6 months follow-up.
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24 hours
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Persistent AF Arm
Tidsramme: 24-hour Holter recording at 9 months follow-up.
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Secondary efficacy endpoints - a) The percent of patients free of AF, regardless of Class I or III antiarrhythmic drug use and not having received additional ablation therapy, as determined by a 24-hour Holter recording, b) improvement in left ventricular ejection fraction and c) left atrial transport function as evidenced by the presence of an A wave at 9 months follow-up.
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24-hour Holter recording at 9 months follow-up.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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 (Faktiske)
19. juni 2008
Primær færdiggørelse (Faktiske)
1. februar 2011
Studieafslutning (Faktiske)
10. juli 2013
Datoer for studieregistrering
Først indsendt
20. november 2020
Først indsendt, der opfyldte QC-kriterier
20. november 2020
Først opslået (Faktiske)
27. november 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
27. november 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. november 2020
Sidst verificeret
1. november 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- European CURE-AF Study
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
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