Remote ECG Monitoring Post TAVI

Medical University of Silesia250 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

250

Conditions

TAVI(Transcatheter Aortic Valve Implantation)Remote Monitoring Arrythmia Atrial Fibrillation (AF)Atrioventricular Block

Interventions

Remote ECG monitoringDEVICE

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

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

Outcomes

Primary Outcomes

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

Time frame: 30 days

Secondary Outcomes

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

Remote ECG Monitoring Post TAVI

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts