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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07521800
- Acronym / sponsor ID
- DRAGON-TAVI / 08
- Conditions
- TAVI(Transcatheter Aortic Valve Implantation), Remote Monitoring, Arrythmia, Atrial Fibrillation (AF), Atrioventricular Block
- Keywords
- TAVI, ECG, Monitoring
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Medical University of SilesiaUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remote ECG monitoring | Experimental | Device: Remote ECG monitoringDevice: continuous 30-day ECG monitoring with visits triggered by ECG findings |
| Standard care | Active comparator | Device: Standard Care (in control arm)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote ECG monitoringPatients 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). | Device | Remote ECG monitoring |
| Standard Care (in control arm)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). | Device | Standard care |
Primary outcome
The first primary endpoint will be the assessment of the total incidence of clinically significant atrio-ventricular block.
Time frame: 30 days
1 secondary outcome
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
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Poland, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wojciech Wańha, MD, PhD (504827636, wojciech.wanha@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The first primary endpoint will be the assessment of the total incidence of clinically significant atrio-ventricular block. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.