An observational study in Atrial Fibrillation, Atrial Flutter and Ventricular Premature Complexes, sponsored by University Hospital Tuebingen. Active, not recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by University Hospital Tuebingen · Observational
Decision between rate control and rhythm control can be a challenge in clinical practice. While there is some guiding evidence, we still lack a comprehensive insight into different subgroups of patients that will benefit from a rhythm control treatment.
EMPATHY is a prospective clinical study in patients presenting with heart failure and a tachyarrhythmic rhythm disturbance. Biomarkers, routinely obtained results from clinical examinations, and results from endomyocardial biopsies shall be evaluated to identify patients which have better outcome from a rhythm control strategy by ablation therapy or, if contraindicated by pharmacological rhythm control.
This study is designed to identifying risk factors and subgroups profiting from rhythm restoration and therefore improve current therapeutic approaches and the rate of recurrence-free survival.
Patients presenting at the University Hospital Tübingen with decreased left ventricular ejection fraction.
Exclusion Criteria:
Sustained heart rate of over 100 bpm, exclusion of other causes of congestive heart failure including significant valvular disease and coronary artery stenosis over 50%, and partial or complete recovery of left ventricular function after restoration of sinus rhythm or rate control and characteristic histological findings.
Patients with dilated cardiomyopathy according to the 2016 ESC (European Heart Association) Guidelines for the diagnosis and treatment of acute and chronic heart failure.
histological characteristics
Identification of histopathological criteria, which indicate better outcome after rhythm control. Recovery of left ventricular ejection fraction (assessed by echocardiography) will be measured.
Time frame: 3 months
recurrence of rhythm disturbance
Evaluating the recurrence of the underlying rhythm disturbance (ECG, 7 day holter monitoring, implantable event recorder)
Time frame: 3 months
rehospitalization
Evaluating the rate of unplanned rehospitalization
Time frame: 3 months
all-cause mortality
Evaluating the all-cause mortality
Time frame: 3 months
NYHA class (New York Heart Association)
Evaluating the extend of heart failure symptoms.
Time frame: 3 months
Plan to share: No
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This study is active, not recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University Hospital Tuebingen