- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00578617
Ablation vs Drug Therapy for Atrial Fibrillation - Pilot Trial (CABANA)
3. december 2012 opdateret af: Mayo Clinic
Catheter Ablation Versus Antiarrhythmic Drug Therapy for Atrial Fibrillation - Pilot Trial
The CABANA pilot study is designed to test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (AF) is superior to current state-of-the-art therapy with either rate control or anti-arrhythmic drugs for reducing AF recurrences at 1 year follow-up.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
- Medicin: Rate Control
- Medicin: Rate Control
- Medicin: Rate Control
- Medicin: Rate Control
- Medicin: Rate Control
- Medicin: Rhythm Control
- Enhed: Ablation Therapy
- Medicin: Rate control
- Medicin: Rate control
- Medicin: Rate control
- Medicin: Rhythm control
- Medicin: Rhythm control
- Medicin: Rhythm control
- Medicin: Rhythm control
- Medicin: Rhythm control
Detaljeret beskrivelse
The need for this trial arises out of 1) the rapidly increasing number of pts > 60 years of age with AF accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of AF on health care costs.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
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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Alabama
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Birminham, Alabama, Forenede Stater, 35233
- Universtity of Alabama Hospital
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California
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Los Angeles, California, Forenede Stater, 90017
- Good Samaritan Hospital
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Illinois
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Maywood, Illinois, Forenede Stater, 60626
- Loyola University
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Iowa
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Des Moines, Iowa, Forenede Stater, 50314
- Mercy Medical Center
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Maryland
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Baltimore, Maryland, Forenede Stater, 21287
- Johns Hopkins Hospital
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02115
- Brigham and Womens Hospital
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Minnesota
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Rochester, Minnesota, Forenede Stater, 55902
- Mayo Clinic
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Ohio
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Columbus, Ohio, Forenede Stater, 43210
- Ohio State University Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Forenede Stater, 19104
- University of Pennsylvania Health
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Utah
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Murray, Utah, Forenede Stater, 84157
- Intermountain Medical Center
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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 90 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Have documented AF, which warrants active drug or ablative treatment
- Be eligible for both catheter ablation and at least 2 sequential anti-arrhythmic drugs and/or 3 sequential rate control drugs
- Be >65 yrs of age, or <65 yrs with one or more of the following risk factors for stroke: Hypertension, Diabetes, Congestive heart failure (including systolic or diastolic heart failure), Prior stroke or transient ischemic attack, Left atrium >4.5 cm, ejection fraction <35% by echocardiogram, radionuclide evaluation or contrast ventriculography
Exclusion Criteria:
- Previously failed 2 or more membrane active anti-arrhythmic drugs
- Efficacy failure of a full dose Amiodarone trial of >12 weeks duration
- Any amiodarone therapy in the past three months
- Reversible causes of AF including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma
- Lone atrial fibrillation in the absence of risk factors for stroke in patients <65 years of age
- Recent cardiac events including myocardial infarction, percutaneous intervention, or valve or coronary bypass surgery in the preceding 3 months
- Hypertrophic obstructive cardiomyopathy
- Class IV angina or congestive heart failure
- Planned heart transplantation
- Other mandated anti-arrhythmic drug therapy
- Heritable arrhythmias or increased risk for "torsade de pointes" (a specific, rare variety of ventricular tachycardia) with class I or III drugs
- Prior left atrial catheter ablation with the intention to treat AF
- Patients with other arrhythmias requiring ablative therapy
- Prior surgical interventions for AF such as the MAZE procedure
- Prior atrioventricular nodal ablation
- Medical conditions limiting expected survival to <1 year
- Contraindication to warfarin anti-coagulation
- Women of childbearing potential
- Participation in any other clinical mortality trial
- Unable to give informed consent
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: Pharmacologic Therapy
Pharmacologic Therapy Rate and/or Sinus Rhythm Control: Patients without other heart disease will receive beta or calcium channel blockers as first line rate control therapy.
Patients with underlying coronary artery disease will receive beta-blockers, patients with limited ventricular hypertrophy not warranting exclusion would receive either beta- or calcium channel blockers, while patients with heart failure would be expected to receive carvedilol or metoprolol.
Patients randomized to drug therapy may be started on a membrane active drug, in an approach consistent with the recommended Guidelines for Management of Subjects with AF.
Each patient will be placed on an anti-arrhythmic drug for an appropriate period and the patient cardioverted to sinus rhythm if necessary.
Patients will then be followed for a period of up to 3 months, during which dosage adjustment can be made or the drug replaced with a different anti-arrhythmic drug.
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Metoprolol 50-100mg
Andre navne:
Atenolol 50-100mg,
Andre navne:
Diltiazem 180-240mg
Andre navne:
Verapamil 180-240mg
Andre navne:
Digoxin 0.125mg
Andre navne:
Propafenone 450mg
Andre navne:
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Aktiv komparator: Ablation Therapy
Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
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Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Number of Participants Experiencing Recurrence of Atrial Fibrillation by One Year Follow-up
Tidsramme: 12 months after intervention
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Documentation of atrial fibrillation using a cardiac event recorder
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12 months after intervention
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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: Douglas L. Packer, M.D., Mayo Clinic
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. september 2006
Primær færdiggørelse (Faktiske)
1. februar 2009
Studieafslutning (Faktiske)
1. juni 2010
Datoer for studieregistrering
Først indsendt
14. december 2007
Først indsendt, der opfyldte QC-kriterier
20. december 2007
Først opslået (Skøn)
21. december 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
4. januar 2013
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. december 2012
Sidst verificeret
1. december 2012
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Hjertesygdomme
- Hjerte-kar-sygdomme
- Arytmier, hjerte
- Atrieflimren
- Molekylære mekanismer for farmakologisk virkning
- Anti-arytmimidler
- Vasodilatorer
- Enzymhæmmere
- Membrantransportmodulatorer
- Cytokrom P-450 CYP3A-hæmmere
- Cytokrom P-450 enzymhæmmere
- Natriumkanalblokkere
- Cytokrom P-450 CYP2D6-hæmmere
- Cytokrom P-450 CYP1A2-hæmmere
- Cytokrom P-450 CYP2C9-hæmmere
- Kaliumkanalblokkere
- Amiodaron
Andre undersøgelses-id-numre
- 06-003867
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 .
Kliniske forsøg med Atrieflimren
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W.L.Gore & AssociatesAfsluttetSeptal defekt, atrialForenede Stater
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Pusan National University HospitalIkke rekrutterer endnuHjerteimplanterbar elektronisk enhed | Atrial High Rate EpisodeKorea, Republikken
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W.L.Gore & AssociatesAfsluttetSeptal defekt, atrialForenede Stater
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Academisch Medisch Centrum - Universiteit van Amsterdam...Tilmelding efter invitationKortkoblet idiopatisk ventrikulær fibrillationHolland
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Assiut UniversityTrukket tilbageASD2 (Secundum atrial septal defekt)
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Henry Ford Health SystemTrukket tilbage
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Nobles Medical Technologies II IncTilmelding efter invitationForamen Ovale, Patent | Septal defekt, atrial | Septaldefekt, HjerteForenede Stater, Italien
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HeartStitch.ComUkendtForamen Ovale, Patent | Septal defekt, atrial | Septaldefekt, HjerteForenede Stater
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University Hospital, Basel, SwitzerlandUniversity Hospital GreifswaldAfsluttetAtrium; Fibrillering | Arytmi AtrialTyskland, Schweiz
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Occlutech International ABAfsluttetSecundum atrial septal defekter
Kliniske forsøg med Rate Control
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Cathay General HospitalChang Gung Memorial Hospital; Cheng-Hsin General Hospital; Chang Gung University og andre samarbejdspartnereUkendtCerebrovaskulær ulykkeTaiwan
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Hadassah Medical OrganizationTel Aviv UniversityAfsluttet
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Cliniques universitaires Saint-Luc- Université...University Hospital of Mont-GodinneAfsluttet
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International Centre for Diarrhoeal Disease Research...Columbia UniversityAfsluttet
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Henry M. Jackson Foundation for the Advancement...Nabi BiopharmaceuticalsAfsluttet
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Indiana UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...RekrutteringSvangerskabsforebyggelse | Udnyttelse af sundhedsvæsenet | PræventionsbrugForenede Stater
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University of California, San FranciscoTrukket tilbage
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Indiana UniversityAfsluttetKolorektal cancerForenede Stater
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Essilor InternationalAktiv, ikke rekrutterende
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Singapore General HospitalDuke-NUS Graduate Medical SchoolUkendtFjern iskæmisk konditionering på blodtrykskontrol hos patienter med kronisk nyresygdom (ERIC-BP-CKD)Hjerte-kar-sygdomme | Forhøjet blodtryk | Kroniske nyresygdommeSingapore