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Tailored Treatment of Permanent Atrial Fibrillation (TTOP-AF)

17. september 2018 opdateret af: Medtronic Cardiac Rhythm and Heart Failure

Tailored Treatment of Permanent Atrial Fibrillation - TTOP-AF

The purpose of this trial is to evaluate the safety and efficacy of the Medtronic Cardiac Ablation System compared to medical therapy in the persistent and long-standing persistent atrial fibrillation population.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

210

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Arizona
      • Scottsdale, Arizona, Forenede Stater, 85251
        • Arizona Arrhythmia Research Center
    • California
      • Los Angeles, California, Forenede Stater, 90095
        • UCLA Cardiac Arrhythmia Center
    • Florida
      • Jacksonville, Florida, Forenede Stater, 32224
        • Mayo Clinic Jacksonville
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30309
        • Piedmont Hospital
      • Atlanta, Georgia, Forenede Stater, 30308
        • Emory Crawford Long Hospital
    • Illinois
      • Chicago, Illinois, Forenede Stater, 60637
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Krannert Institute of Cardiology
    • Iowa
      • Davenport, Iowa, Forenede Stater, 52803
        • Genesis Medical Center
      • Des Moines, Iowa, Forenede Stater, 50309
        • Iowa Heart Center
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21287
        • Johns Hopkins Hospital
      • Takoma Park, Maryland, Forenede Stater, 20912
        • Washington Adventist Hospital
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, Forenede Stater, 02114
        • Massachusetts General Hospital Cardiac Arrhythmia
      • Burlington, Massachusetts, Forenede Stater, 01805
        • Lahey Clinic
    • Michigan
      • Ann Arbor, Michigan, Forenede Stater, 48109
        • University of Michigan
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Spectrum Health Research Department
    • New York
      • Rochester, New York, Forenede Stater, 14642
        • University of Rochester
    • North Carolina
      • Winston-Salem, North Carolina, Forenede Stater, 27157
        • Wake Forest University
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43210
        • The Ohio State University
    • Pennsylvania
      • Erie, Pennsylvania, Forenede Stater, 16502
        • Consultants in Cardiovascular Diseases
    • Texas
      • Austin, Texas, Forenede Stater, 78756
        • Austin Heart
      • Houston, Texas, Forenede Stater, 77030
        • Texas Heart Institute at St. Luke's Episcopal
    • Virginia
      • Norfolk, Virginia, Forenede Stater, 23507
        • Sentara Cardiovascular Research Institute
  • Holland
      • Nieuwegein, Holland
        • St. Antonius Ziekenhuis

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 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

INCLUSION CRITERIA:

  • History of symptomatic, continuous atrial fibrillation defined as: Continuous atrial fibrillation lasting greater than 1 year but less than 4 years or nonself-terminating atrial fibrillation, lasting greater than 7 days but no more than 1 year, with at least one failed direct current cardioversion. A failed cardioversion was defined as an unsuccessful cardioversion or one in which normal sinus rhythm was established but not maintained beyond 7 days.
  • Atrial fibrillation symptoms included the following: palpitations, fatigue,exertional dyspnea, exercise intolerance
  • Age between 18 and 70 years
  • Failure of at least one Class I or III rhythm control drug
  • Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study.

EXCLUSION CRITERIA:

  • Structural heart disease of clinical significance including:

    • Previous cardiac surgery (excluding coronary artery bypass graft and mitral valve repair)
    • Symptoms of congestive heart failure including, but not limited to, New York Heart Association (NYHA) Class III or IV congestive heart failure and/or documented ejection fraction <40% measured by acceptable cardiac testing
    • Left atrial diameter >55 mm
    • Moderate to severe mitral or aortic valvular heart disease
    • Stable/unstable angina or ongoing myocardial ischemia
    • Myocardial infarction (MI) within 3 months of enrollment
    • Congenital heart disease (not including atrial septal defect or patent foramen ovale without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure
    • Prior atrial septal defect of patent foramen ovale closure with a device using a percutaneous approach
    • Hypertrophic cardiomyopathy (left ventricular septal wall thickness >1.5 cm)
    • Pulmonary hypertension (mean or systolic pulmonary artery pressure >50 mm Hg on Doppler echo)
  • Any prior ablation for atrial fibrillation
  • Enrollment in any other ongoing arrhythmia study
  • Any ventricular tachyarrhythmia currently being treated where the arrhythmia or the management may interfere with this study
  • Active infection or sepsis
  • Any history of cerebral vascular disease including stroke or transient ischemic attacks
  • Pregnancy or lactation
  • Left atrial thrombus at the time of ablation
  • Untreatable allergy to contrast media
  • Any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
  • History of blood clotting (bleeding or thrombotic) abnormalities
  • Known sensitivities to heparin or warfarin
  • Severe chronic obstructive pulmonary disease (defined as forced expiratory volume 1 (FEV1) <1)
  • Severe co-morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate

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
Eksperimentel: 1
Ablation Management
Procedure: Medtronic Cardiac Ablation System
Arm 1 (Ablation Management): Ablation procedures using investigational catheters in left atrium. Cardioversion could be used to restore sinus rhythm if needed.
Aktiv komparator: 2
Medical Management
Medicin: Class I or III Antiarrhythmic Medications
Arm 2 (Medical Management): Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current cardioversions were also allowed at the discretion of the investigator.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Chronic Effectiveness
Tidsramme: 6 months

The chronic efficacy endpoint was a treatment success/failure measure for each subject computed at 6 months. Treatment success included:

  1. A 90% reduction in clinically significant atrial fibrillation from baseline to the 6 month time point based on a Holter recording. Clinically significant atrial fibrillation was defined as sustained atrial fibrillation lasting more than 10 minutes.
  2. The subject was off all antiarrhythmic drugs at 6 months (Ablation Management arm only)
  3. The Investigator judged all procedures to be acutely successful (Ablation Management arm only).
6 months
Acute Safety
Tidsramme: 7 days
The primary endpoint for acute safety was a success/failure variable calculated for each subject in Ablation Management at the 7 day post-procedure time point. Any subject with at least one adverse event adjudicated by the Data Safety Monitoring Board as both serious and either probably or definitely procedure and/or device-related occurring within 7 days of the ablation procedure was considered an acute safety failure, regardless of whether the event occurred following the index or retreatment ablation procedure.
7 days
Chronic Safety
Tidsramme: 6 months
The primary endpoint for chronic safety was a success/failure variable calculated for each subject at 6 months. Any subject that had at least one adverse event that met designated seriousness and relatedness criteria for the particular treatment group as adjudicated by the Data Safety Monitoring Board was considered a chronic safety failure. Adverse events in Ablation Management that were acute (≤7 days) were not included in the chronic safety primary endpoint. Given the disparity in the length of time at risk between treatment arms,the Chronic Safety endpoint was not statistically powered.
6 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Acute Efficacy
Tidsramme: Procedure conclusion

A treatment success/failure up to the conclusion of the procedure for each subject in Ablation Management. A subject was considered successfully treated if the following were true:

  • Medtronic ablation catheters were used to achieve procedure success.
  • All accessible pulmonary veins were isolated.
  • At least 50% reduction of complex fractionated atrial electrograms mapped and ablated with Medtronic ablation catheters.
  • Sinus rhythm was achieved upon leaving the electrophysiology lab (±cardioversion).
Procedure conclusion
Improvement of Left Atrial Size at 6 Months Compared to Baseline.
Tidsramme: 6 months
Left atrial diameter (LAD), as measured by transthoracic echocardiogram (TTE) looking at the longitudinal long axis at baseline and at the 6 month follow-up visit in both the Ablation and Medical Management arms.
6 months
Improvement of Left Ventricular Ejection Fraction at 6 Months Compared to Baseline.
Tidsramme: 6 months
Left ventricular ejection fraction (LVEF), as measured by transthoracic echocardiogram at baseline and 6 months in both the Ablation and Medical Management arms.
6 months
Improvement in Atrial Fibrillation (AF) Symptom Severity Scores Over 6 Months Compared to Baseline.
Tidsramme: 6 months
The severity of subject's atrial fibrillation related symptoms on a scale from 1 (no symptoms) to 5 (most severe). The symptoms included palpitations, fatigue, shortness of breath, lightheadedness or dizziness, and lack of energy during exertion or exercise. The scores were tabulated at the 1, 3 and 6 month follow-up visits. Scores could range from 5 to 25, indicating a spectrum of subject status from asymptomatic to severely symptomatic.
6 months
Improved Quality of Life Over 6 Months Compared to Baseline.
Tidsramme: 6 months
The SF-36 questionnaire was administered to subjects at baseline, 1, 3 and 6 month visits. The SF-36 is a multi-purpose, short-form health survey with only 36 questions. It yields an 8-scale profile of functional health and well-being scores as well as psychometrically-based Physical Component Score and Mental Component Score. The possible range for Physical Component Score and Mental Component Score is 0 to 100. The higher score, the better quality of life.
6 months

Samarbejdspartnere og efterforskere

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

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

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.

Generelle publikationer

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. maj 2007

Primær færdiggørelse (Faktiske)

1. november 2010

Studieafslutning (Faktiske)

1. november 2010

Datoer for studieregistrering

Først indsendt

8. august 2007

Først indsendt, der opfyldte QC-kriterier

8. august 2007

Først opslået (Skøn)

10. august 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. oktober 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. september 2018

Sidst verificeret

1. september 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AFI-30

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

Kliniske forsøg med Medtronic Cardiac Ablation System

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