Clinical trial NCT06200311: Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men
Official title: Atrial Fibrillation (AF) Ablation to Prevent Disease Progression of AF-induced Atrial Cardiomyopathy in Women and Men
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fibrillation, Atrial
Atrial Cardiomyopathy
Keywords: pulmonary vein isolation
mHealth
atrial fibrillation
atrial cardiomyopathy
AF ablation
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 604
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients with ACMP and AF will be randomised to AF ablation and pharmacological rhythm management
Primary purpose: TREATMENT

Brief summary: The goal of clinical trial is to compare AF ablation to pharmacological rhythm management (being rate or rhythm control) in AF patients with signs of atrial cardiomyopathy (as defined by left atrial volume index \>34 ml/m2) The main objective it aims to answer is to determine whether AF ablation compared to pharmacological rhythm management in ACMP patients with AF reduces the incidence of the composite primary endpoint of CV death and first CV hospitalization/urgent visit.

Detailed description: The RACE X trial investigates the impact of atrial cardiomyopathy (ACMP) and ablation timing on adverse outcomes in atrial fibrillation (AF) patients. ACMP leads to an atrial substrate less responsive to rhythm control, exacerbating AF recurrence and progression. This trial assesses whether AF ablation versus pharmacological rhythm management reduces the combined primary endpoint of cardiovascular (CV) death and hospitalization in ACMP and AF patients. Secondary objectives include measuring ACMP progression, ACMP-related outcomes, mortality, hospitalizations, AF symptoms, quality of life, and healthcare costs. Exploratory goals involve various additional measurements. This prospective, multicenter, open-label, blinded-endpoint, phase IIIb trial randomizes patients with ACMP and AF to receive either AF ablation or pharmacological rhythm management. Follow-up involves mobile health (mHealth) applications, questionnaires, and heart rhythm monitoring across 13 Dutch hospitals. Ineligible patients undergoing AF ablation join an observational registry. The trial population consists of patients aged 65-80 years with confirmed ACMP and ECG-confirmed AF. With 604 patients and a median 2.5-year follow-up, the trial aims to assign patients equally to each intervention. The primary endpoint is a composite of CV death and hospitalization. Catheter ablation, a safe and efficient technique, minimizes patient burden, and remote follow-up through mHealth reduces site visits. Additional study procedures are integrated into routine care, ensuring a streamlined process.

Eligibility criteria: Inclusion criteria

* Confirmed ACMP (LAVI \>34 ml/m2)
* ECG-confirmed AF
* Age: 65-80 years old
* Patients eligible for both treatment strategies judged by the treating physician signed and dated informed consent prior to admission to the trial

Exclusion criteria

* Longstanding (\>1 year) persistent or permanent (accepted) AF
* Previous left atrial (LA) ablation or LA surgery
* AF due to a reversible cause (e.g. hyperthyroidism, post-operative AF)
* Recent (\<90 days) acute coronary syndrome, stroke/TIA or cardiac intervention (Cardiac interventions include percutaneous coronary intervention, coronary artery bypass grafting, and heart valve repair or replacement (endovascular or surgical))
* Intracardiac thrombus
* HF NYHA III/IV
* Impaired renal function, defined as estimated glomerular filtration rate ≤25 ml/min/1.73m2
* Presence of (or scheduled for) mechanical assist device or heart transplant
* Severe aortic or mitral valve disease
* Complex congenital heart disease
* Life expectancy \<1 year
* Currently enrolled in another clinical randomized trial

Primary outcomes:
measure: A composite of cardiovascular (CV) death and first CV hospitalisation/urgent visit.
timeFrame: through study completion, a median of 2.5 years
Secondary outcomes:
measure: ACMP progression or regression
timeFrame: through study completion, a median of 2.5 years
measure: Hospitalisations/urgent visits for AF, atrial flutter (AFL) or atrial tachycardia (AT)
timeFrame: through study completion, a median of 2.5 years
measure: Hospitalisations/urgent visits for heart failure (HF)
timeFrame: through study completion, a median of 2.5 years
measure: Hospitalisations/urgent visits for ischemic stroke (including transient ischemic attack (TIA))
timeFrame: through study completion, a median of 2.5 years
measure: Cardiovascular death
timeFrame: through study completion, a median of 2.5 years
measure: All-cause mortality
timeFrame: through study completion, a median of 2.5 years
measure: Symptoms and improve quality of life (QoL) measured by EuroQol-5D-5L questionnaire. (higher score indicating a better QoL)
timeFrame: through study completion, a median of 2.5 years
measure: Symptoms and improve quality of life (QoL) measured by Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire (higher score indicating less symptoms and a better QoL)
timeFrame: through study completion, a median of 2.5 years
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: UMCG
Study officials:
affiliation: University Medical Center Groningen
name: Michiel Rienstra, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
References: