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Tailored Treatment of Permanent Atrial Fibrillation (TTOP-AF)

17 september 2018 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

210

Fas

  • Fas 3

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 70 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 1
Ablation Management
Procedur: 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
Läkemedel: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Chronic Effectiveness
Tidsram: 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
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Acute Efficacy
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 maj 2007

Primärt slutförande (Faktisk)

1 november 2010

Avslutad studie (Faktisk)

1 november 2010

Studieregistreringsdatum

Först inskickad

8 augusti 2007

Först inskickad som uppfyllde QC-kriterierna

8 augusti 2007

Första postat (Uppskatta)

10 augusti 2007

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

16 oktober 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

17 september 2018

Senast verifierad

1 september 2018

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • AFI-30

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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