- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01260220
Randomized Trial of Segmental Versus Circumferential Antral Ablation in Paroxysmal Atrial Fibrillation (CABLE)
25. august 2017 opdateret af: Lawson Health Research Institute
An isolation-limited segmental antral approach to pulmonary vein isolation is as effective in achieving long-term freedom from atrial fibrillation as the standard anatomic, circumferential antral ablation.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a randomized controlled non-inferiority designed trial.
Follow up:
Patients will stop their anti-arrhythmic drugs 2 months post procedure. Follow-ups will involve clinical assessment, holter and/or loop recorders at 3, 6, 9, and 12 month intervals.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
120
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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Ontario
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London, Ontario, Canada, N6A 5A5
- London Health Science Centre
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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:
- Paroxysmal Atrial Fibrillation (PAF) for at least 6 months with at least 1 symptomatic episode during the previous 6 moths
- Patient must be felt to be candidates for Atrial Fibrillation (AF) ablation based on AF that is symptomatic and refractory or intolerant to at least one class 1 or 3 anti-arrhythmic agent
- Documentation of at least one episode of AF on 12 lead ECG, TTM or Holter monitor within 12 months of randomization in the trial
- Patient must be on continuous anti-coagulation with warfarin (INR 2-3) or fractionated subcutaneous heparin for >4 weeks prior to the ablation or they have undergone a recent (less than 48 hours before planned ablation) transoesphageal echocardiogram to exclude left atrial thrombus.
- Patient must provide written informed consent to participate in the clinical trial
Exclusion Criteria:
- Contraindications to oral anticoagulants
- History of any previous ablation for AF
- Intracardiac thrombus
- AF due to reversible causes
- Pregnancy
- atriotomy scar (typically, MV or TV repair/replacement, ASD surgery, transplants)(CABG are okay)
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Aktiv komparator: Circumferential
Completing a complete circle of RF lesions around the left and right pulmonary veins
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The goal is to complete ablation in all segments around the pulmonary veins until a circle of ablation lesions is created in the antrum with at least 30 seconds of ablation, 25W on the posterior surface, 30W on the anterior surface at each site, and change in the local electrogram.
Entry and Exit block will be confirmed in each vein.
The left superior pulmonary vein and left inferior pulmonary vein will be isolated with one circle, and the right superior and right inferior pulmonary veins will be isolated with one circle.
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Eksperimentel: Segmental
Isolating the left and right pulmonary veins through RF lesions with a segmental antral approach.
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If the patient is in atrial fibrillation, ablation will begin in the segment with the highest frequency signals in the pulmonary vein antrum.
If the patient is in sinus rhythm, mapping and ablation will occur during coronary sinus pacing.
Segments with the earliest signals in the Lasso catheter will be targeted, and reassessed after each ablation lesion.
This will continue in a segmental fashion on the antrum until pulmonary vein isolation is achieved.
Lasso should be moved between veins between lesions to assess the earliest electrogram.
Entry and exit block will be confirmed at each vein.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Freedom from atrial fibrillation
Tidsramme: six months
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Symptomatic atrial fibrillation recurrence (without anti-arrhythmic med's)
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six months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Procedure time
Tidsramme: (4-6) hours From the time patient is draped to the time electrophysiology catheters are removed from the body (same day in the electrophysiology lab)
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How long did the procedure take?
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(4-6) hours From the time patient is draped to the time electrophysiology catheters are removed from the body (same day in the electrophysiology lab)
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Ablation Time
Tidsramme: (4-6 hours) Measured during the procedure.
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A cumulative measurement of the duration of ablation used during the pulmonary vein isolation procedure.
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(4-6 hours) Measured during the procedure.
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Fluoroscopy Time
Tidsramme: (4-6 Hours) Measured during the procedure.
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A cumulative measurement of flouroscopy time during the pulmonary vein isolation procedure.
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(4-6 Hours) Measured during the procedure.
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complications
Tidsramme: 6 months
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Did the patient experience any complication during the actual pulmonary vein isolation procedure or complication during follow-up related to the procedure?
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6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Lorne J Gula, MD, Western University, Canada
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)
12. november 2009
Primær færdiggørelse (Faktiske)
31. december 2015
Studieafslutning (Faktiske)
31. december 2015
Datoer for studieregistrering
Først indsendt
8. juni 2010
Først indsendt, der opfyldte QC-kriterier
13. december 2010
Først opslået (Skøn)
15. december 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
28. august 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. august 2017
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R-09-489
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 .
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