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Reduction of Fluoroscopy Exposure During Atrial Fibrillation Ablation (AF-FII)

7. oktober 2014 opdateret af: Christopher Piorkowski, Technische Universität Dresden

Atrial Fibrillation Ablation Facilitated by Fluoroscopy Image Integrated 3-dimentional Electroanatomical Mapping System

To evaluate reduction of fluoroscopy time/dosis and safety of atrial fibrillation ablation in patients with paroxysmal atrial fibrillation using fluoroscopy image integrated 3-dimentional electroanatomical mapping system, comparing to using 3-dimentional electroanatomical mapping system without fluoroscopy image integration

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The novel fluoroscopic image integrated 3-dimentional electroanatomical mapping system is designed for minimizing the exposure to X-ray for physician, staff and patients. This randomized single-center study is to evaluate the reduction on fluoroscopy levels (time and dosis) in catheter interventional treatment of symptomatic, antiarrhythmic refractory paroxysmal atrial fibrillation using fluoroscopic image integrated 3-dimentional electroanatomical mapping system, comparing with using 3-dimentional electroanatomical mapping system without fluoroscopic image integration. Patients with documented paroxysmal atrial fibrillation, who are going to receive a catheter interventional treatment to atrial fibrillation, will be randomized (1:1) into two groups after signing an informed consent. Group 1 (CARTOUNIVU): using fluoroscopic image integrated 3-dimentional electroanatomical mapping system. Group 2 (CARTO3): using 3-dimentional electroanatomical mapping system without fluoroscopic image integration.

The ablation strategies in both study groups are the same, including circumferential isolation of ipsilateral pulmonary veins (PV) and voltage map guided substrate modification. According to the randomization, the ablation procedure will be performed with or without fluoroscopic image integration.

The primary endpoint of this study is the evaluation of reduction on fluoroscopy levels (fluoroscopy time and dosis) during atrial fibrillation ablation procedure. Secondary endpoints include complete isolation of the pulmonary veins, completely bidirectional block of linear ablation lines, total procedure time, ablation-related complications.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Tyskland
    • Saxony
      • Dresden, Saxony, Tyskland, 01307
        • Department of Electrophysiology, University of Dresden - Heart Center

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:

  • documented atrial fibrillation in the 12-lead ECG or Holter ECG
  • Paroxysmal symptomatic atrial fibrillation
  • Ineffectiveness of antiarrhythmic medication ( at least 1 medication )
  • Age 18-75 years
  • left atrial diameter <60 mm ( Transesophageal Echocardiography, parasternal )
  • A signed consent form

Exclusion Criteria:

  • Reversible etiology of atrial fibrillation
  • Pregnancy
  • Women of childbearing potential without a negative pregnancy test within 48 hours prior to the ablation procedure
  • Intracardiac thrombus
  • Contraindication to anticoagulation
  • Thromboembolic event in the last 6 months
  • Previous left atrial 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: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CARTOUNIVU
Radiofrequency catheter ablation of atrial fibrillation will be performed using fluoroscopy image integrated 3-dimentional electroanatomical mapping system
Enhed: Radio-frequency catheter ablation
Radio-frequency atrial fibrillation catheter ablation includes circumferential PV isolation and voltage-map guided substrate modification, which means low voltage zone (amplitude < o.5 mV) will also be ablated.
Aktiv komparator: CARTO3
Radiofrequency catheter ablation of atrial fibrillation will be performed using 3-dimentional electroanatomical mapping system without fluoroscopy image integration technique
Enhed: Radio-frequency catheter ablation
Radio-frequency atrial fibrillation catheter ablation includes circumferential PV isolation and voltage-map guided substrate modification, which means low voltage zone (amplitude < o.5 mV) will also be ablated.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Fluoroscopy time for each step of atrial fibrillation ablation procedure
Tidsramme: 1 day ( at the end of each step of atrial fibrillation ablation procedure)
Fluoroscopy time will be recorded at the end of each step of atrial fibrillation ablation, including femoral vein puncture, placement of catheters, transseptal puncture, system registration, reconstruction of left atrium, PV-Angiography, acquirement of voltage map, PV-isolation, confirmation of complete PV isolation and linear ablations.
1 day ( at the end of each step of atrial fibrillation ablation procedure)
Fluoroscopy doses for each step of atrial fibrillation ablation procedure
Tidsramme: 1 day ( at the end of each step of atrial fibrillation ablation procedure)
Fluoroscopy doses will be recorded at the end of each step of atrial fibrillation ablation, including femoral vein puncture, placement of catheters, transseptal puncture, system registration, reconstruction of left atrium, PV-Angiography, acquirement of voltage map, PV-isolation, confirmation of complete PV isolation and linear ablations.
1 day ( at the end of each step of atrial fibrillation ablation procedure)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of patients with adverse events as a measure of safety
Tidsramme: All patients will be followed for the duration of hospital stay for acute complications, an expected average of 3 days.
Perforation, tamponed, phrenic nerve injury and oesophagus injury (patients will be screened for oesophagus injury for a month after atrial fibrillation ablation), etc.
All patients will be followed for the duration of hospital stay for acute complications, an expected average of 3 days.
Number of patients with a failure of reaching endpoints of procedure as a measure of efficacy
Tidsramme: 1 day ( at the end of each step of atrial fibrillation ablation procedure)
number of pulmonary veins/linear ablation lines has not been completely isolated/blocked at the end of the AF ablation
1 day ( at the end of each step of atrial fibrillation ablation procedure)
Total time of atrial fibrillation ablation procedure as a measure of efficacy
Tidsramme: up to 24 hours
procedure time (minute)
up to 24 hours

Samarbejdspartnere og efterforskere

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

Sponsor

Technische Universität Dresden

Samarbejdspartnere

Biosense Webster, Inc.

Efterforskere

  • Ledende efterforsker: Christopher Piorkowski, M.D., Department of Electrophysiology, University of Dresden - Heart Center

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. marts 2014

Primær færdiggørelse (Faktiske)

1. september 2014

Studieafslutning (Faktiske)

1. september 2014

Datoer for studieregistrering

Først indsendt

2. maj 2014

Først indsendt, der opfyldte QC-kriterier

13. maj 2014

Først opslået (Skøn)

14. maj 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

9. oktober 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. oktober 2014

Sidst verificeret

1. oktober 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • EK474122013
  • CARTOUNIVU (Andet bevillings-/finansieringsnummer: Biosense Webster)

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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Kliniske forsøg med Radio-frequency catheter ablation

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Sponsorer og samarbejdspartnere

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Betingelser

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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