Prevention to Improve Outcomes After PVI

Not Applicable

Active, not recruiting

• Conditions: Atrial Fibrillation; Risk Reduction; Nurse's Role

• Registration Number: NCT05148338
• Lead Sponsor: Catharina Ziekenhuis Eindhoven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-25
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Inclusion Criteria:<br><br> - Patients with paroxysmal or persistent symptomatic atrial fibrillation referred for<br> initial catheter ablation<br><br> - Patients should be native Dutch speakers<br><br> - Patients are able to use the VitalHealth Engage platform on their own preferred<br> device (tablet, mobile phone, computer)<br><br> - The patient has at least one of the following risks<br><br> 1. BMI =27 kg/m2,<br><br> 2. hyperlipidaemia (LDL-cholesterol >2.6 mmol/L or total cholesterol >5.0 mmol/L),<br><br> 3. hypertension (blood pressure >130/90 mmHg),<br><br> 4. diabetes mellitus with HbA1c =53 mmol/mol,<br><br> 5. active smoking,<br><br> 6. excess alcohol use (>14 equivalent units of alcohol / week)<br><br>Exclusion Criteria:<br><br> - Longstanding persistent atrial fibrillation (persistent AF for more than 1 year)<br><br> - Permanent atrial fibrillation<br><br> - Asymptomatic atrial fibrillation<br><br> - Prior catheter ablation<br><br> - Paroxysmal atrial fibrillation consisting of one episode with a reversible cause<br> (e.g. fever, surgery, thyroid crisis, ischemic)<br><br> - Severe valvular heart disease<br><br> - Prior or soon foreseen implantation of cardiac device such as pacemaker or internal<br> cardioverter defibrillator<br><br> - Unstable heart failure New York Heart Association (NYHA) IV, or heart failure<br> necessitating admission <3 months before inclusion<br><br> - Cardiac surgery <3 months before inclusion or planned cardiac surgery<br><br> - Patient is not willing to use a mobile phone application or willing to undergo<br> elaborate monitoring.<br><br> - Malignancy<br><br> - Life expectancy <1 year<br><br> - Pregnancy

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of hospital visits for cardioversion of AF and re-ablations

Secondary Outcome Measures

Name	Time	Method
Number of reablations;The composite of mortality, stroke or hospitalization for heart failure or acute ischemic events.;All-cause mortality;Number of strokes;Hospitalizations for heart failure or acute ischemic events;Quality of Life - EQ-5D;Quality of Life - Atrial Fibrillation Effect on QualiTy of life survey (AFEQT);Treatment burden - Treatment Burden Questionnaire (TBQ);Rate of Success for ablation;Number of Cancellations of index ablation;Number of hospital visits for cardioversion of AF