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Tailored Treatment of Permanent Atrial Fibrillation (TTOP-AF)

17 september 2018 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

210

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 70 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Actieve vergelijker: 2
Medical Management
Geneesmiddel: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Chronic Effectiveness
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Acute Efficacy
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 mei 2007

Primaire voltooiing (Werkelijk)

1 november 2010

Studie voltooiing (Werkelijk)

1 november 2010

Studieregistratiedata

Eerst ingediend

8 augustus 2007

Eerst ingediend dat voldeed aan de QC-criteria

8 augustus 2007

Eerst geplaatst (Schatting)

10 augustus 2007

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 oktober 2018

Laatste update ingediend die voldeed aan QC-criteria

17 september 2018

Laatst geverifieerd

1 september 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • AFI-30

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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