TAVI(Transcatheter Aortic Valve Implantation)DRAGON-TAVINCT07521800
Remote ECG Monitoring Post TAVI
A study testing Remote ECG monitoring in people with TAVI(Transcatheter Aortic Valve Implantation) and Remote Monitoring, run by Medical University of Silesia at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TAVI(Transcatheter Aortic Valve Implantation), Remote Monitoring, Arrythmia
- What is being tested?
- Remote ECG monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Dec 2023to 1 Feb 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 2 countries
Poland3 sites, 3 recruiting
- Recruiting
Department of Invasive Cardiology, Medical University of Białystok, Bialystok, Poland
Bialystok
Łukasz Kuźma, kuzma.lukasz@gmail.com
- Recruiting
Medical University of Silesia
Katowice, 40-055
Wojciech Wańha, MD, PhD, 504827636, wojciech.wanha@gmail.com
- Not yet recruiting
Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
Katowice, 40-635
Wojciech Wańha, MD, PhD, 0048504827636, wojciech.wanha@gmail.com
Wojciech Wańha, PhD
Italy1 site, 1 recruiting
- Recruiting
Division of Cardiology, Departement of Medical Science University of Turin, Città della Salute e Della Scienza
Turin
Fabrizio D'Ascenzo, Professor of Medicine
About this study
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.
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.
- Conditions
- TAVI(Transcatheter Aortic Valve Implantation), Remote Monitoring, Arrythmia, Atrial Fibrillation (AF), Atrioventricular Block
- Being tested
- Remote ECG monitoring, Standard Care (in control arm)
- Keywords
- TAVI, ECG, Monitoring
- Medical subject headings
- Arrhythmias, Cardiac, Atrial Fibrillation, Atrioventricular Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote ECG monitoringDevice
Patients will be randomized to the study group (continuous 30-day ECG monitoring with visits triggered by ECG findings) and the 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).
Standard Care (in control arm)Device
Description: Patients will be randomized to the study group (continuous 30-day ECG monitoring with visits triggered by ECG findings) and the 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).
| Study group | Role | What they receive |
|---|---|---|
| Remote ECG monitoring | Experimental | Device: continuous 30-day ECG monitoring with visits triggered by ECG findings Receives: Device: Remote ECG monitoring |
| Standard care | Active comparator | 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 Receives: Device: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The first primary endpoint will be the assessment of the total incidence of clinically significant atrio-ventricular block.
Measured: 30 days
Secondary outcomes (1)
Secondary endpoints will include: All-cause mortality; Major composite adverse cardiovascular events (MACEs, ie, cardiovascular death, stroke, myocardial infarction, hospitalisation for heart failure); Episodes of syncope; cardiac arrhythmias
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Dec 2023
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TAVI(Transcatheter Aortic Valve Implantation)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Silesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wojciech Wańha, Medical University of Silesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521800
- Sponsor's protocol ID
- 08
- Acronym
- DRAGON-TAVI
- Status last verified
- Mar 2026
- First submitted
- 24 Nov 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided