NCT05521451: TRUST

Clinical Cohort Study - TRUST

Recruiting now Last updated 30 March 2025

What this trial tests

trial in Arrhythmias, Cardiac in 5,000 participants. Currently enrolling.

Timeline

17 March 2021

Primary endpoint
30 September 2026

31 December 2031

Quick facts

Lead sponsor	Universitätsklinikum Hamburg-Eppendorf
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	5,000
Start date	17 March 2021
Primary completion	30 September 2026
Estimated completion	31 December 2031
Sites	1 location across Germany

Conditions studied

• Arrhythmias, Cardiac — all drugs for Arrhythmias, Cardiac →
• Atrial Fibrillation — all drugs for Atrial Fibrillation →
• Atrial Flutter — all drugs for Atrial Flutter →
• Ventricular Tachycardia — all drugs for Ventricular Tachycardia →

Sponsor

Universitätsklinikum Hamburg-Eppendorf — full company profile →

Who can join

18 and older, any sex, with Arrhythmias, Cardiac or Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pulsed-field ablation-based pulmonary vein isolation: acute safety, efficacy and short-term follow-up in a multi-center real world scenario.
   Lemoine MD, Fink T, Mencke C, Schleberger R, et al · · 2023 · cited 53× · PMID 36131138 · DOI 10.1007/s00392-022-02091-2
2. Biomarker-based prediction of sinus rhythm in atrial fibrillation patients: the EAST-AFNET 4 biomolecule study.
   Fabritz L, Al-Taie C, Borof K, Breithardt G, et al · · 2024 · cited 19× · PMID 39215973 · DOI 10.1093/eurheartj/ehae611
3. Pulsed-field- vs. cryoballoon-based pulmonary vein isolation: lessons from repeat procedures.
   Lemoine MD, Obergassel J, Jaeckle S, Nies M, et al · · 2024 · cited 18× · PMID 39166530 · DOI 10.1093/europace/euae221
4. Effectiveness and Safety of Pulsed Field Ablation in Patients With Atrial Fibrillation.
   Li R, Zhang X, Liu X, Gu Z, et al · · 2025 · cited 3× · PMID 39896250 · DOI 10.1016/j.jacasi.2024.09.014
5. Comparison of cardiac troponin assays reveals assay-specific sensitivities in a clinical model of very acute myocardial injury.
   Obergassel J, Lemoine MD, Sommerfeld LC, Rieß JL, et al · · 2025 · cited 2× · PMID 40277249 · DOI 10.1093/ehjacc/zuaf064
6. Reduced Vascular Complications After Catheter Ablation Applying Sonography-Guidance and Modified Postprocedural Care.
   Schenker N, Obergassel J, Asbeck C, Lemoine MD, et al · · 2026 · PMID 41797855 · DOI 10.1002/joa3.70302
7. Long-term outcome and predictors for recurrence after medical and interventional treatment of arrhythmias at the UniverSity Heart CenTer Hamburg (TRUST): design and patient profile snapshot of a prospective clinical cohort study.
   Obergassel J, Rieß JL, Jaeckle S, van Elferen S, et al · · 2026 · PMID 41743284 · DOI 10.1093/ehjopen/oeag002
8. Pulmonary vein isolation and beyond: Feasibility and acute outcomes of the lattice-tip dual-energy catheter for complex ablations.
   My I, Nies M, Moser F, Lemoine MD, et al · · 2026 · PMID 41732243 · DOI 10.1016/j.hroo.2025.11.013