Effects of Catheter Ablation on Burden of Atrial Fibrillation (MRICEMAN) (MRICEMAN)
24. december 2015 opdateret af: Heikki Huikuri
A Nationwide Multicenter Trial Assessing the Effects of Catheter Ablation on Burden of Atrial Fibrillation Recorded by Implantable Cardiac Monitor
The study will assess the atrial fibrillation burden recorded By implantable loop recorder at 12 and 24 months compared to baseline.
The patients with clinical indication fo catheter ablation of paroxysmal atrial fibrillation will be randomized to three techniques: manual radiofrequency ablation, radiofrequency ablation using remote magnet monitoring, and cryoablation.
Studieoversigt
Detaljeret beskrivelse
A total of 300 patients will be randomized to three different catheter ablation techniques (100 patients/group); radiofrequency ablation using remote magnet navigation, radiofrequency ablation using manual method, and cryoablation. A loop recorder (REVEAL) is implanted one month before the catheter ablation of paroxysmal atrial fibrillation and the effects of atrial fibrillation burden will be compared between the three methods at 12 and 24 months after ablation excluding the first three months´ blanking period.
The primary endpoints are:
- the proportion of patients remaining free from atrial fibrillation, atrial flutter or atrial tachycardia (> 2 minutes) recorded by the implantable cardiac monitor (Medtronic) at 24 months follow-up and
- total atrial fibrillation burden recorded by the loop recorder.
Other endpoints:
- Atrial fibrillation burden in 7 days Holter recording at 12 and 24 months compared to baseline,
- the time to first documented symptomatic and asymptomatic recurrence of atrial fibrillation
- prescription of antiarrhythmic drugs after the 3 months blanking period following the ablation
- re-ablation after the index ablation procedure,
- total procedural duration;
- total time of fluoroscopy and radiation dose;
- number and duration of cardiovascular hospitalization;
- quality of life questionnaires at 12 months and 24 month compared with baseline,
- cognitive function at 12 and 24 month compared with baseline,
- cost-efficacy of the different ablation techniques.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
300
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Oulu, Finland, 90014
- UOulu
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Oulu, Finland
- Heikki Huikuri
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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 til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion criteria:
- Patients with symptomatic paroxysmal atrial fibrillation fulfilling the contemporary guideline criteria for AF ablation
Exclusion Criteria:
- Any contraindication to catheter ablation
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 |
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Aktiv komparator: manual radiofrequency ablation
Radiofrequency catheter ablation using manual catheter manipulation will be used as an ablation technique.
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Three different catheter ablation techniques will be used aimed at isolating the pulmonary veins from left atrium.The endpoint is defined as absence or dissociation of all pulmonary vein potentials as confirmed by the circular mapping catheter after a waiting period of 30 minutes after the last ablation.
The use of adenosine or isoproterenol to detect concealed pulmonary vein conduction is voluntary.
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Aktiv komparator: magnet navigation ablation
Radiofrequency catheter ablation using remote magnet navigation will be used as an ablation technique.
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Three different catheter ablation techniques will be used aimed at isolating the pulmonary veins from left atrium.The endpoint is defined as absence or dissociation of all pulmonary vein potentials as confirmed by the circular mapping catheter after a waiting period of 30 minutes after the last ablation.
The use of adenosine or isoproterenol to detect concealed pulmonary vein conduction is voluntary.
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Aktiv komparator: cryoablation
Catheter ablation using cryoablation technique will be used as an ablation technique of atrial fibrillation.
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Three different catheter ablation techniques will be used aimed at isolating the pulmonary veins from left atrium.The endpoint is defined as absence or dissociation of all pulmonary vein potentials as confirmed by the circular mapping catheter after a waiting period of 30 minutes after the last ablation.
The use of adenosine or isoproterenol to detect concealed pulmonary vein conduction is voluntary.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Free of atrial fibrillation
Tidsramme: 24 months
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the proportion of patients remaining free from AF, atrial flutter (AFL) or atrial tachycardia (AT) (> 2 minutes) recorded by the implantable cardiac monitor (ICM, Reveal, Medtronic Co.) at 24 months.
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24 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Total AF burden
Tidsramme: 24 months
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total AF burden recorded by the implantable loop recorder during the 24 month follow-up.
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24 months
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Incidence of adverse events
Tidsramme: 24 months
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Safety is one of the secondary endpoints. The following potential adverse events will be monitored: Any previous left atrial ablation or surgery Any cardiac surgery or percutaneous coronary intervention within three months prior to enrolment. Secondary AF Stroke or transient ischemic attack within six months prior to enrolment Myocardial infarction within three months prior to enrolment Left ventricular ejection fraction < 40 % Anteroposterior left atrial diameter >55 mm by transthoracic or transesophageal echocardiography Implanted prosthetic valve |
24 months
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Samarbejdspartnere og efterforskere
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Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Heikki Huikuri, Prof, University of Oulu
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
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. januar 2016
Primær færdiggørelse (Forventet)
1. december 2019
Studieafslutning (Forventet)
1. januar 2020
Datoer for studieregistrering
Først indsendt
9. december 2015
Først indsendt, der opfyldte QC-kriterier
22. december 2015
Først opslået (Skøn)
24. december 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
28. december 2015
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. december 2015
Sidst verificeret
1. december 2015
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AFOulu
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Uafklaret
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