Atrioventricular nodal ablation
ProcedurePatients randomised to this arm would undergo physiological pacing followed by atrioventricular nodal ablation
NCT Number: NCT07059208
The goal of this clinical trial is to compare two procedural approaches to managing atrial fibrillation. The main questions it aims to answer are:
Is AF ablation or pacemaker implant and AV nodal ablation a more effective treatment approach for patients with atrial fibrillation refractory to pharmacological treatment?
What effect do these differing treatment approaches have on patient's quality of life and mental health?
Participants will:
Be randomly allocated to one of the treatment approaches. Visit the clinic 2 months, 12 months and 24 months after their procedure for a checkup, questionnaires and repeat heart ultrasounds.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
The goal of this trial is to compare the effectiveness and safety of pulmonary vein isolation compared with pacemaker implant and atrioventricular nodal ablation for patients with atrial fibrillation.
Patients who have been refractory to attempts at symptom control with pharmacological therapy will be eligible and will be randomised to one of the two approaches.
The primary outcome will be all cause rehospitalisation with secondary outcomes including procedural complications, echocardiographic measurements, patient reported outcomes, all cause mortality and rehospitalisation due to cardiovascular causes. These will be assessed over the 2 years following the index procedure.
The patient reported outcome measures will be the EQ5D, AF Effect on Quality of life score (AFEQT), Hospital anxiety and depression score (HADS) and Somatosensory amplification scale.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients randomised to this arm would undergo physiological pacing followed by atrioventricular nodal ablation
Patients randomised to this arm would undergo catheter ablation targeted at achieving pulmonary vein isolation
Time frame: 2 years
All rehospitalisations for any reason will be included
Contact information is provided by the study sponsor or research team.
Sunshine Coast Hospital and Health Service
Other
Acronym: AVENUE PACE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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