Clinical Cohort Study - TRUST

NCT ID: NCT05521451

Last Updated: 2025-03-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-17

Study Completion Date

2031-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Arrhythmias, Cardiac Atrial Fibrillation Atrial Flutter Ventricular Tachycardia Atrial Tachycardia Arrhythmogenic Right Ventricular Dysplasia Long QT Syndrome Brugada Syndrome Supraventricular Tachycardia Catecholaminergic Polymorphic Ventricular Tachycardia Torsades De Pointes Atrial Cardiomyopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Cardiac arrhythmia, including congenital cardiac arrhythmia diagnosed at baseline or high risk for cardiac arrhythmia
* Age ≥ 18 years
* Written informed consent
* Ability to provide written informed consent in accordance with Good Clinical Practice and local legislation

Exclusion Criteria

* Insufficient knowledge of the German language to understand study documents and interview without translation
* Physical or psychological incapability to cooperate in the investigation
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paulus Kirchhof, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Andreas Metzner, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Andreas Rillig, MD

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

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University Hospital Hamburg-Eppendorf, University Heart and Vascular Center

Hamburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Julius Obergassel, MD

Role: CONTACT

+49 (40) 7410 - 58320

Facility Contacts

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Julius Obergassel, MD

Role: primary

+49 (40) 7410 - 58320

References

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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. 2025 Aug 14. doi: 10.1007/s10840-025-02116-6. Online ahead of print.

Reference Type DERIVED
PMID: 40810874 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37638409 (View on PubMed)

Other Identifiers

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CCS_TRUST

Identifier Type: -

Identifier Source: org_study_id

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