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Clinical Trials in Italy / NCT07521800
Recruiting Not applicable

Remote ECG Monitoring Post TAVI

NCT07521800 · tracked via the Priya Life Science Italy tracker
Sponsor
Medical University of Silesia
Phase
Not applicable
Started
2023-12-01
Last updated
2026-04-13

Condition(s) studied

TAVI(Transcatheter Aortic Valve Implantation)Remote MonitoringArrythmiaAtrial Fibrillation (AF)Atrioventricular Block

Investigational drug(s) / intervention(s)

Remote ECG monitoringStandard Care (in control arm)

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).

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).

Study 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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • The first primary endpoint will be the assessment of the total incidence of clinically significant atrio-ventricular block. — 30 days

Trial sites (4)

FacilityCityRegionStatus
Division of Cardiology, Departement of Medical Science University of Turin, Città della Salute e Della Scienza Turin Italy Recruiting
Department of Invasive Cardiology, Medical University of Białystok, Bialystok, Poland Bialystok Poland Recruiting
Medical University of Silesia Katowice Poland Recruiting
Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland Katowice Poland Not Yet Recruiting

Other trials for the same condition

AV Nodal Ablation With Conduction System Pacing Versus Cardiac Resynchronization for Symptomatic Heart Failure Patients With Atrial Fibrillation Starting soon
ConTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing Recruiting
Clinical Phase 2 Trial of AP31969 Versus Placebo for Rhythm Control of Atrial Fibrillation Recruiting
Natural History of Atrial Fibrillation-Induced Tricuspid Valve Remodeling in the Absence of Significant Tricuspid Regurgitation: A Three-Dimensional Echocardiographic Study Recruiting
Observational Study Relating to the Long-term Follow-up of Patients with Severe Aortic Stenosis Evaluated for Percutaneous Aortic Valve Replacement (TAVI). Enrolling by invitation
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07521800 on ClinicalTrials.gov ↗ ← All trials in Italy