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NCT Number: NCT07521800

Remote ECG Monitoring Post TAVI

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.

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Key information

Conditions

TAVI(Transcatheter Aortic Valve Implantation) Arrhythmias, Cardiac Arrythmia Atrial Fibrillation Atrial Fibrillation (AF) Atrioventricular Block Cardiac Conduction System Disease Cardiovascular Diseases Heart Block Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Remote Monitoring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Remote ECG monitoring

Device

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).

Primary outcomes

  1. The first primary endpoint will be the assessment of the total incidence of clinically significant atrio-ventricular block.

    Time frame: 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

    Time frame: 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Wojciech Wańha, MD, PhD

CONTACT

[email protected]

504827636

Sponsors and collaborators

Lead sponsor

Medical University of Silesia

Other

Registry information

Official study title

Remote ECG Monitoring as a Diagnostic Tool for Therapeutic Strategies After Transcatheter Aortic Valve Replacement: Rationale and Design of the DRAGON-TAVI Trial.

Acronym: DRAGON-TAVI

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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