| NCT ID | NCT07521800 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Silesia |
| Condition | TAVI(Transcatheter Aortic Valve Implantation) |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2027-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2023-12-01 with a primary completion date of 2027-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07521800 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying TAVI(Transcatheter Aortic Valve Implantation). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07521800 currently recruiting?
Yes, NCT07521800 is actively recruiting participants. Contact the research team at wojciech.wanha@gmail.com for enrollment information.
Where is the NCT07521800 trial being conducted?
This trial is being conducted at Turin, Italy, Bialystok, Poland, Katowice, Poland, Katowice, Poland.
Who is sponsoring the NCT07521800 clinical trial?
NCT07521800 is sponsored by Medical University of Silesia. The trial plans to enroll 250 participants.