About this trial
The primary objective of WAVE is to test the hypothesis that thermal ablation (microwave or RFA) is non-inferior to surgery in the biochemical (and if so, in the clinical) cure of unilateral PA, according to the international consensus PASO criteria.
Secondary objectives are to determine whether either intervention is superior to the other in relation to the following outcomes. Where no superiority of either intervention is established, non-inferiority of thermal ablation against adrenalectomy will be sought.
* Frequency and severity of adverse events * Length of inpatient stay * Patient satisfaction * Quality of life * Return to activities of daily living
An additional secondary objective in the thermal ablation group alone will be anatomical efficacy of ablation.
Eligibility criteria
Qualifiers
Age > 18 years
Primary aldosteronism diagnosed according to international guidelines
Unilateral disease by AVS or PET-CT criteria
Ipsilateral radiological abnormality with benign imaging characteristics and technically amenable to both thermal ablation and surgery
Disqualifiers
Absolute contraindication to α- or β-adrenoceptor antagonist therapy or CT contrast
Contraindication or unwillingness for either surgery or thermal ablation
Inability to withdraw β-adrenoceptor antagonist therapy for 2 weeks
Unwilling to undergo either LA or thermal ablation
Trial design
Treatments tested in this trial
- Thermal ablation of aldosterone producing adenoma.
- Unilateral adrenalectomy