NCT07521800

Brief 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Dec 2023

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Dec 2023Feb 2028

Study Start

First participant enrolled

December 1, 2023

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

November 24, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

3.2 years

First QC Date

November 24, 2025

Last Update Submit

April 7, 2026

Conditions

Remote MonitoringArrythmiaAtrioventricular BlockTAVI(Transcatheter Aortic Valve Implantation)Atrial Fibrillation (AF)

Keywords

TAVIECGMonitoring

Outcome Measures

Primary Outcomes (1)

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

    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

    24 months

Study Arms (2)

Remote ECG monitoring

EXPERIMENTAL

Device: continuous 30-day ECG monitoring with visits triggered by ECG findings

Device: Remote ECG monitoring

Standard care

ACTIVE COMPARATOR

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)

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).

Remote ECG monitoring
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).

Standard care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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, 40-055, Poland

RECRUITING

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

Katowice, 40-635, Poland

NOT YET RECRUITING

MeSH Terms

Conditions

Arrhythmias, CardiacAtrial FibrillationAtrioventricular Block

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsHeart BlockCardiac Conduction System Disease

Central Study Contacts

Wojciech Wańha, MD, PhD

CONTACT

504827636wojciech.wanha@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Prof.

Study Record Dates

First Submitted

November 24, 2025

First Posted

April 13, 2026

Study Start

December 1, 2023

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

April 13, 2026

Record last verified: 2026-03

Locations

PL(3)IT(1)