Prevalence, predictors, and prognosis of tricuspid regurgitation following permanent pacemaker implantation.
Jiwon Seo, Dae-Young Kim, Iksung Cho...
https://pubmed.ncbi.nlm.nih.gov/32589674Actively Recruiting
Age: 18Years +
All Genders
ID06914570
Cardiac Implantable Electronic Device-Induced Remodeling of Tricuspid Valve and Right Heart Chambers
Led by Istituto Auxologico Italiano · Updated on 2025-04-06
350
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the occurrence and effects of tricuspid regurgitation (TR) after the implantation of cardiac electronic devices (CIED) using detailed echocardiographic imaging, including advanced 3D transthoracic and transesophageal techniques. This observational study aims to identify how often new or worsening TR occurs following CIED implantation, what causes it, and its clinical impact. The study also explores treatment approaches for lead-related TR and monitors patients over several years to understand heart changes after device implantation. Patients included in the study are those undergoing new CIED implantation with or without leads crossing the tricuspid valve. The study involves comprehensive echocardiographic assessments to evaluate the tricuspid valve and right heart chambers. Follow-up assessments are scheduled at discharge, three months, one year, and then annually up to five years. The study observes morphological and functional heart changes, identifies risk factors, and tracks clinical outcomes related to TR after device implantation. Participants will undergo regular echocardiographic imaging and clinical evaluations throughout the study period, including assessments of heart function and symptoms. Researchers will record outcomes such as changes in TR severity, mortality rates, heart failure hospitalizations, functional heart classification, and any interventions on the tricuspid valve. The study lasts up to five years, allowing detailed observation of the heart's response to CIED implantation over time, with continued monitoring of clinical and imaging findings.
CONDITIONS
Brief Title
Cardiac Implantable Electronic Device- Induced Remodelling of Tricuspid Valve and Right Chambers
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Able and willing to give written informed consent before the procedure
- Understands the study purpose, risks, and benefits and agrees to participate in all follow-up parts
- Undergoing new cardiac implantable electronic device (CIED) implantation with or without transvalvular lead
- Sufficient quality of transthoracic echocardiography imaging to assess tricuspid regurgitation severity and right heart chamber morphology
You will not qualify if you...
- Previous or current cardiac implantable electronic device (CIED)
- Life expectancy less than 12 months due to non-cardiac conditions
- Tricuspid valve stenosis of any severity or severe tricuspid regurgitation planned for intervention within the next 12 months
- Previous tricuspid valve intervention (transcatheter or surgical)
- Participation in another study that would conflict with this trial protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Baseline and up to 5 years
Participants undergo imaging assessments to evaluate the severity of tricuspid regurgitation and morphology of right heart chambers before and after the device implantation.
Visits at baseline, 1 day, 3 months, 1 year, and annually through 5 years
Long-term Monitoring
Duration - Up to 5 years
Participants are monitored for changes in tricuspid valve function, heart failure symptoms, mortality, and any tricuspid valve interventions over 5 years following device implantation.
Regular follow-up visits at 1 day, 3 months, 1 year, and annually through 5 years
Trial Site Locations
Total: 1 location
1
San Luca Hospital
Milan, MI, Italy, 20149
Actively Recruiting
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Research Team
L
Luigi P Badano, MD, Ph.D.
M
Michele Tomaselli, MD, Ph.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Long-Term Follow-Up of Mortality and Heart Failure Hospitalisation in Patients With Intracardiac Device-Related Tricuspid Regurgitation.
Juliana Kanawati, Austin Chin Chwan Ng, Habib Khan...
https://pubmed.ncbi.nlm.nih.gov/33132050Effect of tricuspid regurgitation and right ventricular dysfunction on long-term mortality in patients undergoing cardiac devices implantation: >10-year follow-up study.
Nikolaos Papageorgiou, Debbie Falconer, Nikolas Wyeth...
https://pubmed.ncbi.nlm.nih.gov/32470533Tricuspid Regurgitation and Mortality in Patients With Transvenous Permanent Pacemaker Leads.
Francesca N Delling, Zena K Hassan, Gail Piatkowski...
https://pubmed.ncbi.nlm.nih.gov/26833208Tricuspid regurgitation and implantable devices.
Rasha Al-Bawardy, Amar Krishnaswamy, Jeevanantham Rajeswaran...
https://pubmed.ncbi.nlm.nih.gov/25377489Significant lead-induced tricuspid regurgitation is associated with poor prognosis at long-term follow-up.
Ulas Höke, Dominique Auger, Joep Thijssen...
https://pubmed.ncbi.nlm.nih.gov/24449717Clinical significance of increased tricuspid valve incompetence following implantation of ventricular leads.
Giselle A Baquero, Pradeep Yadav, Joshua B Skibba...
https://pubmed.ncbi.nlm.nih.gov/24022757