No phaseRecruitingAge-related condition

Catheter Ablation vs Conservative Care in Elderly Patients With Atrial Fibrillation (ACE-AF)

Assessment of the Effect of Catheter Ablation on Elderly Population With Atrial Fibrillation; a Randomized Controlled Study; The ACE-AF Study

Sponsor
Karolinska University Hospital (Academic or other)
Enrolment
282 planned
Conditions
Atrial Fibrillation (AF); Atrial Fibrillation Ablation; Elderly
Interventions
Catheter Ablation for Atrial Fibrillation; Optimized Medical Therapy for Atrial Fibrillation; Implantable Loop Recorder (ILR); AV Node Ablation With Pacemaker implantation
Ages
older adults
Registry
NCT07424690

Full record on ClinicalTrials.gov

From the registry

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…

Primary outcomes

  • Composite clinical endpoint (all-cause mortality, stroke, serious bleeding, cardiac arrest, or heart failure hospitalization)
  • Change in RAND-36 General Health score

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered