Remote ECG Monitoring Post TAVI (DRAGON-TAVI)

April 7, 2026 updated by: Wojciech Wańha, Medical University of Silesia

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Turin, Italy
        • Recruiting
        • Division of Cardiology, Departement of Medical Science University of Turin, Città della Salute e Della Scienza
        • Contact:
          • Fabrizio D'Ascenzo, Professor of Medicine
  • Poland
      • Bialystok, Poland
        • Recruiting
        • Department of Invasive Cardiology, Medical University of Białystok, Bialystok, Poland
        • Contact:
      • Katowice, Poland, 40-055
        • Recruiting
        • Medical University of Silesia
        • Contact:
      • Katowice, Poland, 40-635
        • Not yet recruiting
        • Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland
        • Principal Investigator:
          • Wojciech Wojakowski, Prof.
        • Contact:
        • Principal Investigator:
          • Wojciech Wańha, PhD
        • Principal Investigator:
          • Grzegorz Smolka, Prof.
        • Principal Investigator:
          • Krystian Wita, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Remote ECG monitoring
Device: continuous 30-day ECG monitoring with visits triggered by ECG findings
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).
Active Comparator: Standard care
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The first primary endpoint will be the assessment of the total incidence of clinically significant atrio-ventricular block.
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Silesia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

November 24, 2025

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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