Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07521800

Remote ECG Monitoring Post TAVI

Led by Medical University of Silesia · Updated on 2026-04-13

250

Participants Needed

4

Research Sites

217 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Remote ECG Monitoring Post TAVI

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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 such as drug addiction, alcohol abuse, or emotional/mental disorders preventing safe participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Division of Cardiology, Departement of Medical Science University of Turin, Città della Salute e Della Scienza

Turin, Italy

Actively Recruiting

2

Department of Invasive Cardiology, Medical University of Białystok, Bialystok, Poland

Bialystok, Poland

Actively Recruiting

3

Medical University of Silesia

Katowice, Poland, 40-055

Actively Recruiting

4

Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland

Katowice, Poland, 40-635

Not Yet Recruiting

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Research Team

W

Wojciech Wańha, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Remote ECG Monitoring Post TAVI | DecenTrialz