NCT05521451|Recruiting
Clinical Cohort Study - TRUST
TRUST
Longterm Outcome and Predictors for Recurrence After Medical and Interventional Treatment of Arrhythmias At the University Heart Center Hamburg
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TRUST
Longterm Outcome and Predictors for Recurrence After Medical and Interventional Treatment of Arrhythmias At the University Heart Center Hamburg
Sponsor study identifier
observational
5,000
1 country
1
Study Start
March 17, 2021
Actual (reported)Primary Completion
September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 17, 2021
Actual (reported)August 22, 2022
Actual (reported)August 30, 2022
Actual (reported)September 30, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
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.
University Hospital Hamburg-Eppendorf, University Heart and Vascular Center
Hamburg, 20251, Germany
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.
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.
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)
Paulus Kirchhof, MD
Universitätsklinikum Hamburg-Eppendorf
Andreas Metzner, MD
Universitätsklinikum Hamburg-Eppendorf
Andreas Rillig, MD
Universitätsklinikum Hamburg-Eppendorf
First Submitted
August 22, 2022
First Posted
August 30, 2022
Study Start
March 17, 2021
Actual (reported)Primary Completion
September 30, 2026
Estimated (date passed)Smart Watch iECG for the Detection of Cardiac Arrhythmias
Time to recurrence of the clinical arrhythmia
Follow-up 5 years after inclusion
New onset of heart failure
Follow-up 5 years after inclusion
All-cause mortality (Safety Outcome)
Follow-up 5 years after inclusion
Patient reported quality of life (QOL)
Follow-up 5 years after inclusion
Health care utilisation
Follow-up 5 years after inclusion
Contact the study team to confirm eligibility.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
March 30, 2025
Record last verified: 2025-03
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