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Ibutilide Administration During Pulmonary Vein Ablation (IBAD-AFIB)

27. januar 2012 opdateret af: Ball Memorial Hospital

Atrial Fibrillation Mechanism Analysis Through Ibutilide Administration During Pulmonary Vein Ablation.

To test the hypothesis that localized functional reentry maintains Afib in humans, ibutilide will be administered intravenously in patients undergoing an Afib ablation. The hypothesis of this study is that ibutilide will decrease the high frequency signals observed in Afib suggesting the presence of micro reentrant circuits as the basic mechanism of Afib, especially for the paroxysmal Afib group. The potential difference in response to the ibutilide in patients with paroxysmal versus persistent Afib may show the difference in the underlying mechanism of Afib between these two groups.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Medicin: Ibutilide fumarate

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

Fase

Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

Forenede Stater
- Indiana
  - Muncie, Indiana, Forenede Stater, 47303
    - Rekruttering
    - Medical Consultants, P.C.
    - Kontakt:
      
      Sherry Adair, RN
      
      Telefonnummer: 765-254-4761
      
      E-mail: skadair@medicalconsultantspc.com
    - Ledende efterforsker:
      
      Antonio Navarrete, MD

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 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

patients to be scheduled for atrial fibrillation radio frequency ablation
paroxysmal, permanent symptomatic atrial fibrillation refractory to conventional treatment
symptomatic atrial fibrillation that do not want or desire to take medication or undergo cardioversion
patients on antiarrhythmics that can be discontinued 5 half lifes prior to the procedure except for Amiodarone

Exclusion Criteria:

patients with recent major hemorrhage (within 6 months)
patients with a coagulopathy
patients who are pregnant or breast feeding
patients with acute congestive heart failure
patients with hypokalemia or hyperkalemia
patients with a prolonged QTc > 440mms
patients with polymorphic ventricular tachycardia secondary to antiarrhythmic class III and class I
patients with left ventricular dysfunction < 40%
patients with a history of recent MI (< 1 month)
patients with a history of an angioplasty of < 1 month
patients with a history of coronary artery bypass grafting surgery of < 3 months.
patients with a history of chronic renal failure or a creatinine clearance of < 30ml/m
patients with a history of stroke of < 6 months

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Grundvidenskab
Tildeling: N/A
Interventionel model: Enkelt gruppeopgave
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Tidsramme
To discern the basic mechanism of Afib by studying its response to Ibutilide administration. Tidsramme: one year	one year

Sekundære resultatmål

Resultatmål	Tidsramme
To compare the ibutilide response in patients with paroxysmal versus permanent Afib Tidsramme: one year	one year
To study the subgroup of patients that converted to sinus rhythm in order to identify various factors that may have increased their susceptibility to ibutilide. Tidsramme: one year	one year
To improve the current results of pulmonary vein isolation by performing a procedure guided by ablation of high dominant frequency areas. Tidsramme: One year	One year

Samarbejdspartnere og efterforskere

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

Sponsor

Ball Memorial Hospital

Samarbejdspartnere

Abbott Medical Devices

Efterforskere

Ledende efterforsker: Antonio Navarrete, MD, Staff Physician, Ball Memorial Hospital

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. oktober 2007

Primær færdiggørelse (Forventet)

1. december 2015

Studieafslutning (Forventet)

1. december 2016

Datoer for studieregistrering

Først indsendt

26. december 2007

Først indsendt, der opfyldte QC-kriterier