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Rhythm Control - Catheter Ablation With or Without Anti-arrhythmic Drug Control of Maintaining Sinus Rhythm Versus Rate Control With Medical Therapy and/or Atrio-ventricular Junction Ablation and Pacemaker Treatment for Atrial Fibrillation (RAFT-AF)

13. oktober 2021 oppdatert av: Ottawa Heart Institute Research Corporation

A Randomized Ablation-based Atrial Fibrillation Rhythm Control Versus Rate Control Trial in Patients With Heart Failure and High Burden Atrial Fibrillation

Atrial fibrillation and heart failure are two common heart conditions that are associated with an increase in death and suffering. When both of these two conditions occur in a patient the patient's prognosis is poor. These patients have poor life quality and are frequently admitted to the hospital. The treatment of atrial fibrillation in heart failure patients is extremely challenging. Two options for managing the atrial fibrillation are permitting the atrial fibrillation to continue but controlling the heart rate, or to convert the atrial fibrillation rhythm back to normal and try to maintain the heart in sinus rhythm. Until now, the method to keep the patient in normal sinus rhythm is with antiarrhythmic drugs. Studies using antiarrhythmic drugs to control the rhythm failed to show any survival benefit when compared with permitting the patient to be in atrial fibrillation. In the last few years, new development in techniques and technologies now enable catheter ablation (cauterization of tissue in the heart with a catheter) to be a successful treatment in abolishing atrial fibrillation and that this approach is better than antiarrhythmic drug to control the rhythm. However, there has not been any long-term study to determine whether catheter ablation to abolish atrial fibrillation in heart failure patients would reduce mortality or admissions for heart failure.

This study is to compare the effect of catheter ablation-based atrial fibrillation rhythm control to rate control in patients with heart failure and high burden atrial fibrillation on the composite endpoint of all-cause mortality and heart failure events defined as an admission to a healthcare facility for > 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic and an increase in chronic heart failure therapy. This study may have a dramatic impact on the way the investigators manage these patients with atrial fibrillation and heart failure and may improve the outlook and well being of these patients.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

Substudy_ In a subset of patients, following informed consent, additional data collection will include annual NT-proBNP/BNP measurements, Echocardiogram baseline and annually and 14 Day ECG Continuous Monitoring at six month intervals.

Studietype

Intervensjonell

Registrering (Faktiske)

411

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brasil, 90620-001
        • Instituto de Cardiologia-FUC RS
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Libin Cardiovascular Institute of Alberta, Calgary
      • Edmonton, Alberta, Canada, T5H 3V9
        • Royal Alexandra Hospital
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Vancouver General
      • Victoria, British Columbia, Canada, V8R 4R2
        • Royal Jubilee Hospital
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 3A7
        • Queen Elizabeth II Health Science
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Hamilton Health Sciences Centre
      • Kingston, Ontario, Canada, K7L 2V7
        • Kingston General Hospital
      • Kitchener, Ontario, Canada, N2M 1B2
        • St. Mary's General Hospital
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre
      • Newmarket, Ontario, Canada, L3Y 8C3
        • Southlake Regional Health Care
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 2M9
        • Toronto General Hospital, University Health Network
    • Quebec
      • Montreal, Quebec, Canada, H3A 1A1
        • McGill University Health Centre
      • Montreal, Quebec, Canada, H1T 1C8
        • Institute de Cardiologie de Montréal
      • Montreal, Quebec, Canada, H2L 4M1
        • CHUM Centre hospitalier universitaire de Montréal
      • Quebec City, Quebec, Canada, G1V 4G5
        • Insitut universitaire de cardiologie and pneumologie de Quebec
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • CHUS Centre Hospitalier Universitaire de Sherbrooke
      • Stockholm, Sverige, S-171 76
        • Karolinska University Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Patients with one of the following AF categories and at least one ECG documentation of AF

    • High burden Paroxysmal defined as ≥ 4 episodes of AF in the last 6 months, and at least one episode > 6 hours (and no episode requiring cardioversion and no episode > 7 days)
    • Persistent AF (1) defined as ≥ 4 episodes of AF in the last 6 months, and at least one episode > 6 hours, and at least one AF episode less than 7 days but requires cardioversion. No AF episodes are > 7 days
    • Persistent AF (2) as defined by at least one episode of AF > 7 days but not > 1 year
    • Long term persistent AF defined as an AF episode, at least one year in length and no episodes > 3 years
  2. Optimal therapy for heart failure of at least 6 weeks (according to 2009 ACCF/AHA class 1 recommendations).
  3. HF with NYHA class II or III symptoms with either impaired LV function (LVEF ≤ 45%) as determined by EF assessment within the previous 12 months or preserved LV function (LVEF > 45%) determined by by EF assessment within the previous 12 months
  4. NT-pro BNP measures:

    A) Patient has been hospitalized for Heart Failure* in the past 9 months, has been discharged AND:

    i- Is presently in Normal Sinus Rhythm and NT-pro BNP is ≥ 400 pg/mL

    ii- Is presently in Atrial Fibrillation and NT-pro BNP is ≥ 600 pg/mL

    OR

    B) Patient has had no hospitalization for Heart Failure in the past 9 months AND:

    i- Has had paroxysmal Atrial Fibrillation, is presently in Normal Sinus Rhythm and NT-proBNP is ≥ 600 pg/mL

    ii- Is presently in Atrial Fibrillation and NT-proBNP is ≥ 900 pg/mL

    *Heart Failure Admission is defined as admission to hospital > 24 hours and received treatment for Heart failure

  5. Suitable candidate for catheter ablation or rate control therapy for the treatment of AF
  6. Age ≥18

Exclusion Criteria:

  1. Have an LA dimension > 55 mm as determined by an echocardiography within the previous year
  2. Had an acute coronary syndrome or coronary artery bypass surgery within 12 weeks
  3. Have rheumatic heart disease, severe aortic or mitral valvular heart disease using the AHA/ACC guidelines
  4. Have congenital heart disease including previous ASD repair, persistent left superior vena cava
  5. Had prior surgical or percutaneous AF ablation procedure or atrioventricular nodal (AVN) ablation
  6. Have a medical condition likely to limit survival to < 1 year
  7. Have New York Heart Association (NYHA) class IV heart failure symptoms
  8. Have contraindication to systematic anticoagulation
  9. Have renal failure requiring dialysis
  10. AF due to reversible cause e.g. hyperthyroid state
  11. Are pregnant
  12. Are included in other clinical trials that will affect the objectives of this study
  13. Have a history of non-compliance to medical therapy
  14. Are unable or unwilling to provide informed consent

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Rhythm Control
Patients randomized to catheter ablation-based AF rhythm control group will receive optimal Heart Failure therapy and one or more aggressive catheter ablation, which include PV antral ablation and LA substrate ablation with or without adjunctive antiarrhythmic drug.
Patients randomized to catheter ablation-based AF rhythm control group will receive optimal HF therapy and one or more aggressive catheter ablation, which include PV antral ablation and LA substrate ablation with or without adjunctive antiarrhythmic drug
Andre navn:
  • Kateterablasjon
Aktiv komparator: Rate Control
Patients in the rate control group will receive optimal Heart Failure therapy and rate control measures to achieve a resting HR < 80 bpm and 6-minute walk HR < 110 bpm.
Patients in the rate control group will receive optimal HF therapy and rate control measures to achieve a resting HR < 80 bpm and 6-minute walk HR < 110 bpm.
Andre navn:
  • Standard medical therapy

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Composite of all-cause mortality and heart failure events
Tidsramme: Baseline to a minimum of 24 months
Heart failure event defined as an admission to a healthcare facility for > 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic as accepted by FDA and an increase in chronic heart failure therapy
Baseline to a minimum of 24 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
All-cause mortality
Tidsramme: Baseline to a minimum of 24 months
All-cause mortality
Baseline to a minimum of 24 months
Heart Failure events
Tidsramme: Baseline to a minimum of 24 months
Heart failure event defined as an admission to a healthcare facility for > 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic as accepted by FDA and an increase in chronic heart failure therapy
Baseline to a minimum of 24 months
Health related QoL
Tidsramme: Baseline to a minimum of 24 months
Minnesota Living with Heart Failure. Scoring: The higher the score, the worse the HRQL
Baseline to a minimum of 24 months
Health related QoL
Tidsramme: Baseline to a minimum of 24 months
EuroQol- 5 Dimension. Scoring 0 = worst to 100 = best
Baseline to a minimum of 24 months
Health related QoL
Tidsramme: Baseline to a minimum of 24 months
Atrial Fibrillation Effect on Quality-of-life. Scoring 0 = worst to 100 = best
Baseline to a minimum of 24 months
Exercise capacity
Tidsramme: Baseline to a minimum of 24 months
as determined by 6 Minute Hall walk distance
Baseline to a minimum of 24 months
NT-proBNP/BNP at 1 year and at 2 year follow-up
Tidsramme: Baseline to a minimum of 24 months
NT-proBNP/BNP
Baseline to a minimum of 24 months
All-cause mortality and heart failure events in patients with HF, impaired (LVEF≤45%) LV function and high burden AF
Tidsramme: Baseline to a minimum of 24 months
Baseline to a minimum of 24 months
All-cause mortality and heart failure events in patients with HF, preserved (LVEF > 45%) LV function and high burden AF
Tidsramme: Baseline to a minimum of 24 months
Baseline to a minimum of 24 months
Health economics
Tidsramme: Baseline to a minimum of 24 months
Cost economics
Baseline to a minimum of 24 months

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
LV function and remodeling (LVESVi) at 1 year and 2 year follow-up
Tidsramme: Baseline to a minimum of 24 months
Echocardiogram measure LVESVi
Baseline to a minimum of 24 months
AF Burden at 1 year and 2 year follow-up
Tidsramme: Baseline to a minimum of 24 months
14 Day Continuous ECG monitoring
Baseline to a minimum of 24 months
Total number of heart failure events
Tidsramme: Baseline to a minimum of 24 months
Heart failure event defined as an admission to a healthcare facility for > 24 hours or clinically significant worsening heart failure leading to an intervention (defined as treatment in an emergency department, a same-day access clinic, or an infusion centre) or unscheduled visits to a healthcare provider for administration of an intravenous diuretic as accepted by FDA and an increase in chronic heart failure therapy
Baseline to a minimum of 24 months
Total number of Cardiovascular hospitalizations
Tidsramme: Baseline to a minimum of 24 months
Cardiovascular hospitalizations
Baseline to a minimum of 24 months
Safety (Adverse Events)
Tidsramme: Baseline to a minimum of 24 months
Thromboembolic events, symptomatic Pulmonary vein stenosis, atrio-esophageal fistula, pericardial effusion requiring pericardiocentesis, major bleeding requiring blood transfusion, amiodarone induced thyroid, pulmonary and other toxicity
Baseline to a minimum of 24 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Anthony Tang, MD FRCPC, Western University
  • Hovedetterforsker: George Wells, PhD, Ottawa Heart Institute Research Corporation

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2011

Primær fullføring (Faktiske)

1. mai 2021

Studiet fullført (Faktiske)

1. juni 2021

Datoer for studieregistrering

Først innsendt

17. august 2011

Først innsendt som oppfylte QC-kriteriene

18. august 2011

Først lagt ut (Anslag)

19. august 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

21. oktober 2021

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. oktober 2021

Sist bekreftet

1. oktober 2021

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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