The effectivity of lifestyle interventions and prevention in patients with atrial fibrillation referred for ablation; a randomised-controlled trial

Recruiting

Conditions: atrial fibrillation
cardiac arrhytmia
10007521

Registration Number: NL-OMON50896

Lead Sponsor: Catharina-ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

Patients with paroxysmal or persistent atrial fibrillation referred for initial
catheter ablation
Age 18-75 years
The patient should have at least on treatable risk factor (BMI >=27 kg/m2,
hyperlipidaemia, hypertension, diabetes mellitus with HbA1c >=53 mmol/mol,
active smoking, or excess alcohol use)
Patients are willing and able to use the VitalHealth Engage platform on their
own preferred device

Exclusion Criteria

Longstanding persistent atrial fibrillation (persistent atrial fibrillation for
more than 1 year)
Permanent atrial fibrillation
Asymptomatic atrial fibrillation
Prior ablation
Severe valvular heart disease
Prior or soon foreseen implantation of cardiac device
Acute coronary syndroom < 3 months before inclusion
Unstable heart failure NYHA IV or heart failure necessitating admission <3
months before inclusion
Cardia surgery <3 months before inclusion
Life expectancy <1 year
Pregnancy

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study endpoint is the number of cardioversions and re-ablations from<br /><br>patient inclusion up to 12 months after the ablation. We will also include<br /><br>events that occur before the ablation and within the first three months after<br /><br>the ablation, the so called blanking period. We expect that the proposed<br /><br>intervention will lead to a 30% reduction of the primary endpoint.<br /><br>The primary outcome is the composite of hospital admissions for cardioversion<br /><br>and re-ablations with a follow-up of 12 months after the index ablation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Total hospitalisations for cardioversion<br /><br>- Total hospitalisations for re-ablation<br /><br>- The composite of mortality, stroke or hospitalisation for heart failure or<br /><br>acute ischemic events<br /><br>- Total mortality<br /><br>- Stroke<br /><br>- Hospitalisation for heart failure or acute ischemic events<br /><br>- Success of ablation<br /><br>- Cancelation of index ablation<br /><br>- Medical costs, resource utilization, and cost-effectiveness and patient value<br /><br>- Quality of life<br /><br>- Treatment burden<br /><br>- Ablation procedure<br /><br>- Adherence to lifestyle interventions<br /><br>- Effect of OSA screening<br /><br>- Exploration of patient experience and its main determinants in the new<br /><br>outpatient clinic<br /><br>- Exploration of staff experience and its main determinants in the new<br /><br>outpatient clinic</p><br>