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Arrhythmias, CardiacTRUSTNCT05521451

Clinical Cohort Study - TRUST

An observational study of Arrhythmias, Cardiac and Atrial Fibrillation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
5,000 participants
Where
1 siteGermany
Study dates
17 Mar 2021to 31 Dec 2031
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Julius Obergassel, MD contact

+49 (40) 7410 - 58320

trust@uke.de

Germany1 site, 1 recruiting

  • University Hospital Hamburg-Eppendorf, University Heart and Vascular Center

    Hamburg, 20251

    Julius Obergassel, MD, +49 (40) 7410 - 58320, trust@uke.de

    Recruiting

Other trials in Germany

About this study

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

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.

Read the detailed description

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.

Keywords
Catheter Ablation, Biomarkers, Cardiac Arrhythmia, eHealth, Digital Cardiology, Echocardiography, Atrial Cardiomyopathy
Medical subject headings
Arrhythmias, Cardiac, Atrial Fibrillation, Atrial Flutter, Tachycardia, Ventricular, Arrhythmogenic Right Ventricular Dysplasia, Long QT Syndrome, Brugada Syndrome, Tachycardia, Supraventricular

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Follow-up 5 years after inclusion

  2. 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.

    Measured: Follow-up 5 years after inclusion

Secondary outcomes (6)

  1. 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.

    Measured: Follow-up 5 years after inclusion

  2. 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.

    Measured: Follow-up 5 years after inclusion

  3. 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.

    Measured: Follow-up 5 years after inclusion

  4. Patient reported quality of life (QOL)

    As assessed via AF Effect on QualiTy of life survey at the timepoint of follow-up.

    Measured: Follow-up 5 years after inclusion

  5. 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.

    Measured: Follow-up 5 years after inclusion

  6. 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.

    Measured: Follow-up 5 years after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2022
  2. Study start17 Mar 2021
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion31 Dec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
5,000 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT05521451
Sponsor's protocol ID
CCS_TRUST
Acronym
TRUST
Status last verified
Mar 2025
First submitted
22 Aug 2022
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 41732243

  • 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.

    PubMed 40810874

  • 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.

    PubMed 37638409

Questions about this trial

What is this clinical trial studying?

An observational study of Arrhythmias, Cardiac and Atrial Fibrillation, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Julius Obergassel, MD (+49 (40) 7410 - 58320, trust@uke.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to a composite of cardiovascular mortality, stroke, acute coronary syndrome and heart failure hospitalization (time frame: Follow-up 5 years after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05521451, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.

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