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Remote ECG Monitoring Post TAVI

RECRUITINGN/ASponsored by Medical University of Silesia
Actively Recruiting
PhaseN/A
SponsorMedical University of Silesia
Started2023-12-01
Est. completion2027-02-01
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07521800

Summary

The DRAGON TAVI study is a multicenter, prospective, open, randomised trial, which will enrol 250 patients, randomized 1:1 to the study group (continuous 30-day ECG monitoring with visits triggered by ECG findings) and standard care (ie. control group, which will receive the standard post op 24-48h ECG monitoring and a regular follow-up visit with standard ECG within 30 days). The duration of the study is 12 months ± 1 month.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Patient age over 18 years old
* Severe aortic stenosis
* Moderate or high cardiovascular risk based on current ESC Guidelines "Heart Team" qualification for TAVI
* Written informed consent of the patient for participation in the study

Exclusion Criteria:

* History of atrial fibrillation or atrial flutter
* Previously known conduction disturbances\*\*
* Presence of: pacemaker, CRT-P, ICD, CRT-D before or after TAVI
* Ischaemic stroke, TIA, MI or heart surgery within 1 month before TAVI qualification
* Haemorrhagic stroke within 1 year before TAVI qualification
* Chronic immunosuppressive therapy
* Comorbidities (e.g. drug addiction, alcohol abuse, emotional/mental disorders) which do not allow safe participation in the study

Conditions6

ArrythmiaAtrial Fibrillation (AF)Atrioventricular BlockHeart DiseaseRemote MonitoringTAVI(Transcatheter Aortic Valve Implantation)

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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