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The "Long-term Outcome and Predictors for Recurrence after Medical and Interventional Treatment of Arrhythmias at the University Heart Center Hamburg" (TRUST) study is an investor-initiated, single-center, prospective clinical cohort study including patients treated with cardiac arrhythmias or at high risk for cardiac arrhythmias. The design enables prospective, low-threshold, near complete inclusion of patients with arrhythmias treated at the UHZ. Collection of routine follow-up data, detailed procedural information and systematic biobanking will enable precise and robust phenotyping.
Arrhythmias such as atrial fibrillation, ventricular tachycardia, and sudden death remain major causes of morbidity and mortality. Their prevalence increases in our ageing populations. Modern therapy of these conditions, using a combination of drugs, devices, and interventions, can reduce the disease burden associated with cardiac arrhythmias. This prospective cohort study will collect detailed clinical, procedural, and outcome information in a large cohort of patients with arrhythmias seen in a tertiary care center. Clinical phenotyping will be enhanced by biosampling and analysis of circulating biomolecules. Digital capture of clinical information and of follow-up data is planned.
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| Measure | Description | Time Frame |
|---|---|---|
| Time to a composite of cardiovascular mortality, stroke, acute coronary syndrome and heart failure hospitalization | The main primary outcome measures the time until any of death from cardiovascular cause, stroke or TIA or a hospitalization due to heart failure or acute coronary syndrome occurs for the first time after inclusion. The outcome is measured via telephone and / or in-person follow-up, acquisition of all relevant medical records between inclusion and follow-up timepoint and a questionnaire sent to the patient. The follow-up can be completed fully electronically according to patient's wish. | Follow-up 5 years after inclusion |
| New onset of cardiac arrhythmias, documented in clinical care and during systematic rhythm monitoring using digital devices. | The outcome is measured via remote follow-up using consumer-electronics based remote rhythm monitoring technologies. Additionally, onset of new cardiac arrhythmias is assessed from medical records collected between follow-up timepoint and inclusion as well as questionnaires and a telephone call with the patient. | Follow-up 5 years after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Time to recurrence of the clinical arrhythmia | The outcome is measured via remote follow-up using consumer-electronics based remote rhythm monitoring technologies. Additionally, onset of new cardiac arrhythmias is assessed from medical records collected between follow-up timepoint and inclusion as well as questionnaires and a telephone call with the patient. | Follow-up 5 years after inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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Patients seen in the Department of Cardiology of the University Heart and Vascular Center Hamburg suffering from cardiac arrhythmias, including congenital cardiac arrhythmias, or being at high risk for cardiac arrhythmias.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julius Obergassel, MD | Contact | +49 (40) 7410 - 58320 | trust@uke.de |
| Name | Affiliation | Role |
|---|---|---|
| Paulus Kirchhof, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Andreas Metzner, MD | Universitätsklinikum Hamburg-Eppendorf | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Hamburg-Eppendorf, University Heart and Vascular Center | Recruiting | Hamburg | 20251 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41732243 | Derived | My I, Nies M, Moser F, Lemoine MD, Rottner L, Govorov K, Schenker N, Zarfelder A, Schoof L, Kirchhof P, Reissmann B, Ouyang F, Metzner A, Rillig A. Pulmonary vein isolation and beyond: Feasibility and acute outcomes of the lattice-tip dual-energy catheter for complex ablations. Heart Rhythm O2. 2025 Nov 25;7(2):212-220. doi: 10.1016/j.hroo.2025.11.013. eCollection 2026 Feb. | |
| 40810874 |
| Label | URL |
|---|---|
| Related Info | View source |
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Blood sampling at baseline: Whole blood, serum, cellular RNA Collection of tissue samples excised in clinical routine (e. g. left atrial appendages after surgical closure)
| New onset of heart failure | This endpoint is defined as a new diagnosis of heart failure with (milly) reduced or preserved ejection fraction according to ESC guidelines. The patients medical record will be reassessed at the end of follow-up. | Follow-up 5 years after inclusion |
| All-cause mortality (Safety Outcome) | This endpoint is assessed during the telephone call during remote follow-up and - if not applicable - via consultation of the death registry. | Follow-up 5 years after inclusion |
| Patient reported quality of life (QOL) | As assessed via AF Effect on QualiTy of life survey at the timepoint of follow-up. | Follow-up 5 years after inclusion |
| Health care utilisation | Health care utilisation after inclusion is assessed during the telephone call of the remote follow-up as well as via acquisition of all medical records between follow-up timepoint and inclusion. | Follow-up 5 years after inclusion |
| Complications of rhythm control therapy (Safety Outcome) | This endpoint is assessed during the telephone call of the remote follow-up as well as via acquisition of all medical records between follow-up timepoint and inclusion. | Follow-up 5 years after inclusion |
| Andreas Rillig, MD |
| Universitätsklinikum Hamburg-Eppendorf |
| Principal Investigator |
| Derived |
| My I, Moser F, Loeck FW, Obergassel J, Rottner L, Lemoine MD, Kirchhof P, Steven D, Sultan A, Willems S, Meyer C, Reissmann B, Rillig A, Metzner A, Ouyang F. Long-term outcome of catheter ablation of left fascicular ventricular arrhythmias. J Interv Card Electrophysiol. 2026 Jan;69(1):35-41. doi: 10.1007/s10840-025-02116-6. Epub 2025 Aug 14. |
| 37638409 | Derived | Wenzel JP, Lemoine MD, Rottner L, My I, Moser F, Obergassel J, Nies M, Riess J, Ismaili D, Nikorowitsch J, Ouyang F, Kirchhof P, Rillig A, Metzner A, Reissmann B. Nonthermal Point-by-Point Pulmonary Vein Isolation Using a Novel Pulsed Field Ablation System. Circ Arrhythm Electrophysiol. 2023 Sep;16(9):e012093. doi: 10.1161/CIRCEP.123.012093. Epub 2023 Aug 28. No abstract available. |
| Related Info | View source |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D001281 | Atrial Fibrillation |
| D001282 | Atrial Flutter |
| D017180 | Tachycardia, Ventricular |
| D019571 | Arrhythmogenic Right Ventricular Dysplasia |
| D008133 | Long QT Syndrome |
| D053840 | Brugada Syndrome |
| D013617 | Tachycardia, Supraventricular |
| D000098850 | Polymorphic Catecholaminergic Ventricular Tachycardia |
| D016171 | Torsades de Pointes |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |
| D006330 | Heart Defects, Congenital |
| D018376 | Cardiovascular Abnormalities |
| D009202 | Cardiomyopathies |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
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