- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05774821
Surgical Treatment of Tricuspid Valve Regurgitation in Patients With Cardiac Implantable Electronic Devices: Long Term Results
Old trials aimed to evaluate Implantable Cardioverter-Defibrillator (ICD) safety and efficacy demonstrated a meaningful decreased rates of sudden death but an increased rate of hospitalization for heart failure . At the time, the chance that an endocardial lead could cause a significant tricuspid regurgitation (TR), leading to worsening heart failure, was not widely considered. Whereas, it is now well established that in patients with cardiac implantable electronic device (CIEDs), moderate or severe TR occurs frequently and it is associated with increased mortality and hospitalization for heart failure.
The present study aims to report the long-term results of tricuspid valve repair and replacement surgery in patients with CIEDs Indeed, patients with TR and CIEDs can be divided in 2 categories: CIEDs induced TR and CIEDs associated TR. In patients with CIEDs induced TR, the valve dysfunction is directly caused by the lead with several mechanism such as mechanical interference with tricuspid valve (TV) leaflet mobility and coaptation (impingement), valve damage during lead placement or manipulation and sub-valvular entanglement. In patients with CIEDs associated TR the valve dysfunction is not directly caused by the lead.
In 2009 approximately 720 000 CIEDs were implanted worldwide [7] and since then a continuous increase of CIEDs implantation was registered, with an estimation of 1.4 millions of CIEDs implantation in 2023. With this impressive number of CIEDs requirement, the need for surgical or trans-catheter treatment of severe TR CIEDs induced or associated, increased steadily in the past years and it likely will continue to increase in the next years. However, limited data are available regarding the outcome of tricuspid valve surgery in patients with CIEDs, particularly for the long-term results. With this study we aim to report the long-term result of tricuspid valve repair and replacement in patients with CIEDs.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Milan, Italy, 20132
- IRCCS Ospedale San Raffaele
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients;
- Patients with significant, surgically treatable tricuspid regurgitation (TR) according to guidelines
- Patients with an implantable electronic heart device (CIEDs)
- Patients undergoing surgery, both repair or replacement, of the tricuspid valve, both isolated or associated with intervention on the valves of the left heart sections.
- Patients operated at the Cardiac Surgery Department of the San Raffaele Hospital from 2000 to 2019.
Exclusion Criteria:
- Patients without a CIED
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
TR recurrency
Time Frame: Through study completion, an average of 7 years
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Through study completion, an average of 7 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
All causes mortality
Time Frame: Through study completion, an average of 7 years
|
Through study completion, an average of 7 years
|
cardiac mortality
Time Frame: Through study completion, an average of 7 years
|
Through study completion, an average of 7 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TR-CIED-LTR
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Tricuspid Regurgitation
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Icahn School of Medicine at Mount SinaiNational Heart, Lung, and Blood Institute (NHLBI); Canadian Institutes of Health... and other collaboratorsActive, not recruitingTricuspid Regurgitation | Mild Tricuspid Regurgitation | Moderate Tricuspid RegurgitationUnited States, Canada, Germany
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IRCCS Policlinico S. DonatoRecruitingTricuspid Regurgitation CongenitalItaly
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Heart Center Leipzig - University HospitalRecruitingFunctional Tricuspid RegurgitationGermany
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University of ZurichRecruitingSevere Tricuspid RegurgitationSwitzerland
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P+F Products + Features GmbHCompletedSevere Tricuspid RegurgitationLithuania
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Innoventric LTDNot yet recruitingTricuspid Regurgitation | Tricuspid Regurgitation Functional
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Charite University, Berlin, GermanyRecruitingFunctional Tricuspid RegurgitationGermany, Israel
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P+F Products + Features GmbHCompletedSevere Tricuspid RegurgitationSpain, Austria
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Cardiac Implants LLCRecruitingFunctional Tricuspid Regurgitation (TR)Israel, Czechia, France
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Michele De BonisCompletedFunctional Tricuspid RegurgitationItaly
Clinical Trials on Tricuspid valve surgery
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University of Maryland, BaltimoreEdwards LifesciencesCompletedCardiac Surgery | Tricuspid Valve RegurgitationUnited States
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Michele De BonisCompletedTricuspid RegurgitationItaly
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Ettore Sansavini Health Science FoundationUnknownTricuspid (Valve) Insufficiency (Rheumatic)Italy
-
Ettore Sansavini Health Science FoundationUnknownTricuspid Valve InsufficiencyItaly
-
Ottawa Heart Institute Research CorporationEnrolling by invitationTricuspid RegurgitationUnited States, Spain, Israel, Canada, France, Germany, Netherlands, Switzerland, Austria, Italy
-
Medtronic Bakken Research CenterCompletedTricuspid Valve InsufficiencyFrance, Israel, Germany
-
CorMatrix Cardiovascular, Inc.Yale UniversityRecruitingTricuspid Valve Insufficiency | Tricuspid Valve DiseaseUnited States
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Edwards LifesciencesActive, not recruitingTricuspid RegurgitationUnited States
-
CorMatrix Cardiovascular, Inc.Recruiting
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Edwards LifesciencesActive, not recruitingCardiovascular Diseases | Heart Valve Diseases | Tricuspid Valve RegurgitationUnited States, Canada, France, Switzerland