Remote ECG monitoring after TAVI
Official title: Remote ECG Monitoring as a Diagnostic Tool for Therapeutic Strategies After Transcatheter Aortic Valve Replacement: Rationale and Design of the DRAGON-TAVI Trial.
Run by Medical University of Silesia · NCT07521800 · Data updated 2026-11-12
This compares continuous 30-day remote ECG monitoring to standard short-term monitoring for adults after TAVI to see if it detects rhythm problems earlier.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 250 (estimated) |
| Sponsor | Medical University of Silesia Academic / other |
| Locations | 4 sites (Turin and 3 other locations) |
| Status | Recruiting |
| Started | December 1, 2023 |
| Main results expected | February 1, 2027 |
| Study ends | February 1, 2028 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT07521800 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 with severe aortic stenosis judged moderate or high cardiovascular risk by a Heart Team and scheduled for TAVI who give informed consent and have no prior AF/flutter or implanted pacing/defibrillator devices.
✕Probably not a fit
Patients with a history of atrial fibrillation/flutter, known conduction disorders, existing pacemaker/ICD, or those unable to use remote monitoring technology are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The DRAGON TAVI trial is a multicenter, prospective, open-label, randomized 1:1 trial enrolling 250 adults undergoing transcatheter aortic valve implantation (TAVI). Participants are assigned to either continuous 30-day remote ECG monitoring with visits triggered by abnormal ECG findings or to standard care consisting of 24–48 hour post‑op ECG monitoring plus a routine ECG within 30 days. The study follows patients for approximately 12 months to capture new atrial fibrillation, atrioventricular block, and clinically relevant events leading to intervention. Key exclusions include prior atrial fibrillation/flutter, known conduction disturbances, and presence of pacemaker/ICD devices.
Why it matters
Potential benefit: If successful, earlier detection of post‑TAVI arrhythmias could allow faster treatment and may reduce complications and unplanned hospital visits.
How similar studies have gone: Similar extended or remote ECG monitoring approaches have increased detection of post‑procedure arrhythmias in other settings, but continuous 30‑day remote monitoring after TAVI is not yet established as standard care.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Division of Cardiology, Departement of Medical Science University of Turin, Città della Salute e Della Scienza
Turin, Italy Recruiting -
Department of Invasive Cardiology, Medical University of Białystok, Bialystok, Poland
Bialystok, Poland Recruiting -
Medical University of Silesia
Katowice, Poland Recruiting -
Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
Katowice, Poland Not yet recruiting
Study contacts
- Study coordinator: Wojciech Wańha, MD, PhD
- Email: wojciech.wanha@gmail.com
- Phone: 504827636
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.