Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
ID05521451

Longterm Outcome and Predictors for Recurrence After Medical and Interventional Treatment of Arrhythmias At the University Heart Center Hamburg

Led by Universitätsklinikum Hamburg-Eppendorf · Updated on 2025-03-30

5000

Participants Needed

1

Research Sites

274 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are conducting a prospective clinical cohort study called TRUST to better understand long-term outcomes and factors that predict recurrence in patients treated for cardiac arrhythmias or those at high risk for arrhythmias. This study focuses on conditions such as atrial fibrillation, ventricular tachycardia, and other serious arrhythmias that contribute significantly to illness and death, especially in aging populations. It aims to collect detailed clinical and procedural information alongside systematic biobanking to enable precise patient characterization. Participants will be enrolled at a single tertiary care center specializing in heart conditions. The study involves collecting routine follow-up data and detailed information about treatments, including medications, devices, and interventions used to manage arrhythmias. Biosamples will be collected for molecular analysis, and digital tools will be used to capture clinical data and monitor heart rhythms over time. During the study, participants will undergo systematic rhythm monitoring with digital devices and regular clinical assessments over a five-year follow-up period. Researchers will evaluate outcomes such as cardiovascular mortality, stroke, heart failure hospitalizations, new arrhythmias, and quality of life. Safety outcomes including complications from rhythm control therapies and overall survival will also be monitored. The study aims for near-complete inclusion of eligible patients treated at the center to gather robust real-world data.

CONDITIONS

Brief Title

Clinical Cohort Study - TRUST

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - At baseline

Participants undergo clinical phenotyping and biosampling to collect detailed clinical and procedural information related to their arrhythmia.

1 baseline visit (in-person)

Long-term Monitoring

Duration - Up to 5 years after inclusion

Participants are monitored for cardiovascular events, arrhythmia recurrence, and quality of life over an extended period after inclusion.

Regular follow-up visits and digital rhythm monitoring over 5 years

Trial Site Locations

Total: 1 location

1

University Hospital Hamburg-Eppendorf, University Heart and Vascular Center

Hamburg, Germany, 20251

Actively Recruiting

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Research Team

J

Julius Obergassel, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Pulmonary vein isolation and beyond: Feasibility and acute outcomes of the lattice-tip dual-energy catheter for complex ablations.

Ilaria My, Moritz Nies, Fabian Moser...

https://pubmed.ncbi.nlm.nih.gov/41732243