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New treatment option for TAVI(Transcatheter Aortic Valve Implantation)
Official title Remote ECG Monitoring Post TAVI
ClinicalTrials.gov ID: NCT07521800
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Turin, Italy
- Bialystok, Poland
- Katowice, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turin, Italy; Bialystok, Poland; Katowice, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.