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Effektivitetsforsøk med kirurgisk ablasjon av AF (SAFE)

2. oktober 2026 oppdatert av: Richard Whitlock, Population Health Research Institute

SAFE is an international multicentre RCT of concomitant surgical atrial fibrillation (AF) ablation in patients with paroxysmal or persistent AF undergoing cardiac surgery.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

Atrial fibrillation (AF) affects more than 1% of the general population and is an important risk factor for stroke. AF prevalence increases with age, occurring in 10 to 15% of patients older than 80 years of age, which is important with the aging population. Of patients undergoing cardiac surgery, 10.8% have a history of AF. AF is believed to cause the left atrium to dilate and lose its transport function. AF significantly increases the risk of ischemic stroke of cardioembolic origin, but is also associated with heart failure and impairs quality of life. Although the causal relationship between the 2 clinical entities has not been fully elucidated, AF is believed to cause heart failure via several mechanisms.

Ablation of AF is the application of scars to the atrial tissue to disrupt faulty electrical signals that cause the arrhythmia. If surgical ablation of AF yields a benefit similar to catheter-based AF ablation, thousands of people undergoing cardiac surgery could benefit from this procedure each year. SAFE will be a landmark trial in cardiac surgery, definitely establishing surgical AF ablation's impact on cardiovascular outcomes. Cardiac surgery is the optimal setting to establish whether maintenance of sinus rhythm through AF ablation yields clinical benefit, and is a setting where sham-control is possible. This will not only provide evidence for the cardiac surgical patients but will bolster the evidence for ablation (catheter or stand-alone surgical) in other AF patients.

The intervention under investigation is concomitant surgical AF ablation which is compared to no surgical AF ablation. The primary outcome is hospital readmissions with heart failure during 4 years of follow-up. This study will enroll 2000 patients from 50 centres, globally. Patients will be followed at hospital discharge, 4 to 6 weeks after surgery, 6 months after surgery, and then at 6-month intervals until the final follow-up visit, for a median follow-up for 4 years.

Studietype

Intervensjonell

Registrering (Antatt)

2000

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Rekruttering
        • Hamilton General Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Richard Whitlock, MD MSc FRCSC

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:

  • Age ≥ 18 years;
  • Undergoing a clinically indicated cardiac surgical procedure: CABG, AVR, ascending aorta replacement, or combinations thereof;
  • Documented history of paroxysmal or persistent AF
  • Provide informed consent

Exclusion Criteria:

  • Dominant atrial arrhythmia is atrial flutter;

  • Documented left atrial diameter ≥ 6 cm;

  • Previous cardiac surgery requiring opening of the pericardium;

  • Patients undergoing any of the following procedures:

    1. Heart transplant
    2. Complex congenital heart surgery
    3. Sole indication for surgery is ventricular assist device insertion
    4. Mitral valve repair or replacement
    5. Tricuspid valve repair or replacement

  • Patient resides in a long-term care facility

Studieplan

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

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Surgical Atrial Fibrillation Ablation Group

Surgeon will perform left atrial ablation during patient's cardiac surgery procedure.
Fremgangsmåte: Surgical Atrial Fibrillation Ablation

Surgeon will preform surgical atrial fibrillation ablation using either cryoablation or bipolar radiofrequency clamps including 2 layers of atrium or vein, a minimum of 2 burns per clamping with at least 3 lines in the ablation group. Cavo-tricuspid isthmus and mitral lines will be allowed.
Ingen inngripen: No Surgical Atrial Fibrillation Ablation Group

Surgeon will not perform left atrial ablation during the patient's cardiac surgery procedure.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of hospital readmissions for heart failure over duration of follow-up
Tidsramme: Common termination point for trial (median follow-up of 4 years)

Total number of hospital readmissions for heart failure.
Common termination point for trial (median follow-up of 4 years)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Ischemic stroke or systemic arterial embolism events over duration of follow up
Tidsramme: Common termination point for trial (median follow-up of 4 years)

Number of Ischemic stroke or systemic arterial embolism events over duration of follow up
Common termination point for trial (median follow-up of 4 years)
Length of ICU stay
Tidsramme: From the date of study intervention surgery completion to the date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)

Length of ICU stay, including readmissions, from study intervention surgery to hospital discharge, including readmissions
From the date of study intervention surgery completion to the date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)
Length of hospital stay
Tidsramme: From the date of study intervention surgery completion to the date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)

Length of hospital stay
From the date of study intervention surgery completion to the date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)
Freedom from recurrence of atrial tachyarrhythmia
Tidsramme: 1 year post-operatively

Freedom from recurrence of atrial tachyarrhythmia
1 year post-operatively
Number of days free from admission to healthcare facility or presentation to the emergency department for heart failure
Tidsramme: Common termination point for trial (median follow-up of 4 years)

Number of days free admission to healthcare facility or presentation to the emergency department for heart failure
Common termination point for trial (median follow-up of 4 years)
All-cause mortality
Tidsramme: Common termination point for trial (median follow-up of 4 years)

All-cause mortality
Common termination point for trial (median follow-up of 4 years)
Cardiovascular mortality
Tidsramme: Common termination point for trial (median follow-up of 4 years)

Cardiovascular mortality
Common termination point for trial (median follow-up of 4 years)
Antiarrhythmic drug use
Tidsramme: Beyond 6 weeks until common termination point for trial (median follow-up of 4 years)

Antiarrhythmic drug use
Beyond 6 weeks until common termination point for trial (median follow-up of 4 years)
Number of patients undergoing atrial fibrillation ablation
Tidsramme: 90 days post- study surgery until common termination point for trial (median follow-up of 4 years)

Number of patients undergoing atrial fibrillation ablation
90 days post- study surgery until common termination point for trial (median follow-up of 4 years)
Quality of Life - atrial fibrillation specific
Tidsramme: At 1 year, and at common termination point for trial (median follow-up of 4 years)

Atrial fibrillation specific quality of life as assessed by the Atrial Fibrillation Effect on QualiTy of Life questionnaire (AFEQT) which is 20 questions using a 7 point Likert scale where a higher score means a worse outcome.
At 1 year, and at common termination point for trial (median follow-up of 4 years)
Quality of Life - heart failure specific
Tidsramme: At 1 year, and at common termination point for trial (median follow-up of 4 years)

Heart failure specific quality of life assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) which is a 12 questions using Likert scales where a higher score is a better outcome.
At 1 year, and at common termination point for trial (median follow-up of 4 years)
Quality of Life - General
Tidsramme: At 1 year, and at common termination point for trial (median follow-up of 4 years)

Quality of life- general as assessed by the European quality of life index version 5D (EQ-5D-5L) which consists of a descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
At 1 year, and at common termination point for trial (median follow-up of 4 years)

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Ischemic stroke and systemic arterial embolism
Tidsramme: Up to 30 days post-operatively

Safety outcome
Up to 30 days post-operatively
Number of patients requiring permanent pacemaker implantation
Tidsramme: Up to 1 year post-operatively

Safety outcome
Up to 1 year post-operatively
Volume of chest tube output
Tidsramme: Up to 24 hours post-operatively

Safety outcome - chest tube output measured in mL.
Up to 24 hours post-operatively
Re-operation for bleeding
Tidsramme: From date of study intervention surgery completion to date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)

Safety outcome
From date of study intervention surgery completion to date of index hospital discharge, assessed up to the common termination point for trial (median follow-up of 4 years)
All-cause mortality
Tidsramme: Prior to discharge or within 30 days post-operatively (whichever occurs first)

Safety outcome
Prior to discharge or within 30 days post-operatively (whichever occurs first)
Post-operative major bleeding
Tidsramme: <48 hours after surgery

Safety outcome
<48 hours after surgery
Number of patients with pulmonary vein stenosis
Tidsramme: At 1 year, and at common termination point for trial (median follow-up of 4 years)

Safety outcome
At 1 year, and at common termination point for trial (median follow-up of 4 years)
Number of patients with stiff left atrium syndrome
Tidsramme: At 1 year, and at common termination point for trial (median follow-up of 4 years)

Safety outcome
At 1 year, and at common termination point for trial (median follow-up of 4 years)
Number of patients with esophageal to atrial fistula
Tidsramme: At 1 year, and at common termination point for trial (median follow-up of 4 years)

Safety outcome
At 1 year, and at common termination point for trial (median follow-up of 4 years)
Health economic analysis of surgical atrial fibrillation
Tidsramme: At 1 year, and at common termination point (median follow-up of 4 years)

Economic analysis will be assessed via health care utilization by patients
At 1 year, and at common termination point (median follow-up of 4 years)
Health economic analysis of surgical atrial fibrillation
Tidsramme: At 1 year, and at common termination point (median follow-up of 4 years)

Economic analysis will be assessed via a questionnaire of health care visits and costs incurred by patients.
At 1 year, and at common termination point (median follow-up of 4 years)

Samarbeidspartnere og etterforskere

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

Sponsor

Population Health Research Institute

Samarbeidspartnere

Hamilton Health Sciences Corporation

Etterforskere

  • Hovedetterforsker: Richard Whitlock, Population Health Research Institute
  • Hovedetterforsker: Emilie Belley-Côté, Population Health Research Institute

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 (Faktiske)

1. juni 2023

Primær fullføring (Antatt)

30. september 2027

Studiet fullført (Antatt)

31. desember 2027

Datoer for studieregistrering

Først innsendt

4. mai 2022

Først innsendt som oppfylte QC-kriteriene

22. juni 2022

Først lagt ut (Faktiske)

28. juni 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

2. oktober 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • SAFEV1.0

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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