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Recruiting NCT07521800

Remote ECG Monitoring Post TAVI

No phase Interventional TAVI(Transcatheter Aortic Valve Implantation) Remote Monitoring Arrythmia Atrial Fibrillation (AF)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Remote ECG monitoring, Standard Care (in control arm).
Who it may be relevant to
Registry conditions: TAVI(Transcatheter Aortic Valve Implantation), Remote Monitoring, Arrythmia, Atrial Fibrillation (AF). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy, Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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.

Interventions

  • Device Remote ECG monitoring
    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 (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).

Primary outcome measures

  • The first primary endpoint will be the assessment of the total incidence of clinically significant atrio-ventricular block. [Time frame: 30 days]
Secondary outcome measures (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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

Poland · 3 centers
  • Department of Invasive Cardiology, Medical University of Białystok, Bialystok, Poland — Bialystok
  • Medical University of Silesia — Katowice
  • Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Kat — Katowice
Italy · 1 center
  • Division of Cardiology, Departement of Medical Science University of Turin, Città della Sa — Turin

Identifiers

NCT: NCT07521800 · 08

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗