IntegRAted chronic care program at specialized AF clinic versus usual CarE in patients with Atrial Fibrillation, a Multicenter Randomized Controlled Clinical Trial

Completed

• Conditions: 10014523; 'Atrial Fibrillation' 'Irregular heartbeat'; 10007521

• Registration Number: NL-OMON47091
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-10-01
• Results First Posted: 2019-09-23
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1375

Inclusion Criteria

1. Patients with newly diagnosed AF detected on electrocardiogram (ECG), holter recordings
or eventrecorder with a duration > 30 seconds, 3 months before inclusion;
2. Patients with a history of diagnosed AF, with no regular control at a cardiologist for AF in the last
2 years and referred by a non-cardiologic medical specialist for new diagnostics or therapeutic issue;
3. Age * 18 years.

Exclusion Criteria

1. No electrocardiographic objectified AF;
2. Unstable heart failure defined as NYHA IV or heart failure necessitating hospital admission < 3 months before inclusion;
3. Acute coronary syndrome (acute myocardial infarction or instable angina pectoris, with two of the following characteristics: chest pain and/ or ischemic electrocardiographic changes, and/ or cardiac enzyme rise) < 3 months before inclusion;
4. Untreated hyperthyroidism or < 3 months euthyroidism before inclusion;
5. Foreseen pacemaker, internal cardioverter defibrillator (ICD), and/ or cardiac resynchronization therapy (CRT);
6. Cardiac surgery * 3 months before inclusion;
7. Planned cardiac surgery;
8. Regular control and treatment, also for AF, at another specialized outpatient cardiac clinic;
9. Patient is not able to fill in the questionnaires;
10. Participation in other clinical study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified