Atrial Fibrillation Clinical Trial
— TRUSTOfficial title:
Longterm Outcome and Predictors for Recurrence After Medical and Interventional Treatment of Arrhythmias at the University Heart Center Hamburg
NCT number | NCT05521451 |
Other study ID # | CCS_TRUST |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 17, 2021 |
Est. completion date | December 31, 2031 |
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.
Status | Recruiting |
Enrollment | 5000 |
Est. completion date | December 31, 2031 |
Est. primary completion date | September 30, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | University Hospital Hamburg-Eppendorf, University Heart and Vascular Center | Hamburg |
Lead Sponsor | Collaborator |
---|---|
Universitätsklinikum Hamburg-Eppendorf |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Secondary | 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. | Follow-up 5 years after inclusion | |
Secondary | 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. | Follow-up 5 years after inclusion | |
Secondary | 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. | Follow-up 5 years after inclusion | |
Secondary | Patient reported quality of life (QOL) | As assessed via AF Effect on QualiTy of life survey at the timepoint of follow-up. | Follow-up 5 years after inclusion | |
Secondary | 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. | Follow-up 5 years after inclusion | |
Secondary | 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. | Follow-up 5 years after inclusion |
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