atrial fibrillation supraventricular tachycardia
Conditions
Interventions
Management of AF and early optimization of CRT via Home Monitoring.
Sponsors
Biotronik
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Indication for CRT with ICD backup, documented paroxysmal or persistent AF within one year prior to enrolment (preoperative or evaluation phase), Optimized heart failure-related medication
Exclusion criteria
Exclusion criteria: Permanent AF, Contraindication to anticoagulation, Stroke within 6 weeks prior to enrolment, Acute coronary syndrome within 2 months prior to enrolment, Cardiac surgery within 2 months prior to enrolment, Acute myocarditis Severe chronic obstructive pulmonary disease, Planned cardiac surgery or interventional measures within 3 months after enrolment, Dialysis dependency, Life expectancy 11 mm.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical composite outcome based on the days lost due to cardiovascular mortality, cardiovascular hospitalization and Inappropriate ICD therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular mortality, cardiovascular mortality or hospitalization, inappropriate ICD therapy, HF Clinical Composite Score (Packer Score), appropriate ICD therapy, time to first AF therapy, reverse remodelling (LA diameter, LVESV, mitral regurgitation), NYHA class, Quality of Life (Minnesota Living with Heart Failure), progression of AF, AT/AF burden, % biventricular pacing, requirement for rhythm control therapy, requirement for rate control therapy, ventricular rate during rate control. | — |
Countries
Netherlands
Outcome results
None listed