Status:
RECRUITING
Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers
Lead Sponsor:
Istituto Auxologico Italiano
Conditions:
Cardiac Pacing, Artificial
Tricuspid Valve Regurgitation, Non-rheumatic
Eligibility:
All Genders
18+ years
Brief Summary
This single-center longitudinal study aims to evaluate the occurrence and clinical impact of tricuspid regurgitation (TR) after cardiac-implanted-electronic-device (CIED) implantation by comprehensive...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Patient able and willing to give informed consent in written form before the index procedure
- Patient understands the purpose, the potential risks as well as benefits of the study and is willing to participate in all parts of the follow-up
- Patients undergoing any new CIED implantation with or without transvalvular lead
- Sufficient imaging quality on transthoracic echocardiography to assess TR severity grade and morphology of right-sided heart chambers
Exclusion
- Previous or present CIED
- Life expectancy \< 12 months due to non-cardiac condition
- Tricuspid valve stenosis of any severity or severe TR planned for intervention (transcatheter, surgical) within the next 12 months
- Previous tricuspid valve intervention (transcatheter, surgical)
- Participation in another study, which would lead to deviations from this trial protocol
Key Trial Info
Start Date :
May 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 24 2029
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT06914570
Start Date
May 1 2024
End Date
February 24 2029
Last Update
April 6 2025
Active Locations (1)
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1
San Luca Hospital
Milan, MI, Italy, 20149