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Catheter Ablation vs Conservative Care in Elderly Patients With Atrial Fibrillation

Study acronym: ACE-AF
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 44 days later Nov 1, 2031 → Dec 15, 2031
See other at-risk trials from Karolinska University Hospital

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Recruitment opened Show 6 more changesShow less
    • Study sites: 1 to 2
    • Start date changed from estimate of Sep 15, 2026 to Oct 5, 2026
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints: details revised at 12 of 13 entries
    • Study description revised
    • Publications: details revised at 13 of 14 entries
  2. Notable Start date: May 20, 2026 to Sep 15, 2026v2 Show 4 more changesShow less
    • Primary completion pushed from Nov 1, 2031 to Dec 15, 2031
    • Study completion date: Sep 1, 2034 to Sep 15, 2034
    • Study description expanded, about 29 words
    • Collaborators revised (8)
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
ACE-AF is a multicenter randomized study in people aged 78 years and older with symptomatic atrial fibrillation (AF). AF is a common heart rhythm disorder in older adults and can cause reduced quality of life and lead to serious complications such as stroke and heart failure. The study compares two established treatment strategies: 1. Catheter ablation (an invasive procedure aimed at reducing AF by electrically isolating triggers in the heart, primarily through pulmonary vein isolation), and 2. Optimized medical therapy without AF ablation (medications for rate and/or rhythm control; AV node ablation with pacemaker may be used if clinically indicated according to routine care). Participants are randomized 1:1 to one of these strategies. All participants will receive an implantable loop recorder (a small heart rhythm monitor placed under the skin) to continuously track heart rhythm and measure AF burden over time. The study has two primary endpoints, tested with Holm-Bonferroni multiplicity control assessed over 24 months: 1. a composite of major clinical events (all-cause mortality, stroke, major bleeding, cardiac arrest, or hospitalization due to heart failure), and 2. patient-reported health-related quality of life (HRQoL), measured by the RAND-36 "General Health" domain. ACE-AF will provide evidence to guide treatment decisions for very elderly patients with symptomatic AF and help identify which patients benefit most from an ablation-based strategy compared with optimized medical therapy.
Trial Details
NCT Number NCT07424690
Lead Sponsor Karolinska University Hospital
Collaborators: University Hospital, Linkoeping, Sahlgrenska University Hospital, University Hospital, Umeå, Dept of Cardiology, Örebro University Hospital, Sweden, Lund University Hospital, Onassis Cardiac Surgery Centre, Uppsala University Hospital, Royal Adelaide Hospital
Conditions
(from sponsor)
Atrial Fibrillation (AF), Atrial Fibrillation Ablation, Elderly
Related terms Atrial Fibrillation
Enrollment 282 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov