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NCT05006443 Clinical Trial

Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques

Tricuspid Regurgitation Clinical Trial

Official title:
Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05006443
Other study ID # 21-003928
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date January 14, 2022
Est. completion date December 2024

Study information
Verified date March 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this research is to assess the severity of tricuspid regurgitation (a disorder in which the tricuspid valve in the heart does not close tight enough) using cardiac magnetic resonance imaging (MRI).

Description:

40 patients with moderate or more TR on echocardiography will undergo CMR/MRE with contrast to assess TR severity, and the associated extra-valvular cardiac and liver abnormalities as shown in the flow diagram below. Patients will continue their clinical management by their primary physicians as per the standards of care. 1-year follow up will be conducted via phone to inquire about patient's vital status (dead/alive), symptoms and hospitalizations.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 75
Est. completion date December 2024
Est. primary completion date December 12, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Moderate or more tricuspid regurgitation Exclusion Criteria: 1. Prior tricuspid valve prosthesis 2. Pacemaker/defibrillator that would impede MRI imaging 3. Planned tricuspid valve surgery 4. Primary liver pathology

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Cardiac Magnetic Resonance
a non-invasive assessment to determine severity of tricuspid regurgitation

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Severity of tricuspid regurgitation by cardiac magnetic resonance imaging Incidence of severity of TR by CMR as compared with current gold standard (TTE) 1 year
Secondary Correlation between severity of Tricuspid regurgitation by cardiac magnetic resonance imaging vs. elastography Correlation between severity of TR by CMR vs. echocardiography with 1-year composite endpoint of death, heart failure hospitalization, or tricuspid valve surgery. 1 year
See also
  Status Clinical Trial Phase
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Completed NCT03144024 - Comparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency N/A
Enrolling by invitation NCT05825898 - Outcome of Patients With Severe Functional TR According to Medical, Transcatheter or Surgical Treatment
Completed NCT05836493 - Very Long-term (>15 Years) Results of Tricuspid Valve Repair.
Enrolling by invitation NCT06033274 - Global Multicenter Registry on Transcatheter TRIcuspid Valve RePLACEment
Recruiting NCT05671640 - Feasibility Study of the DragonFly-T System for Severe Tricuspid Regurgitation N/A
Recruiting NCT06027307 - Enavogliflozin Outcome Trial in Functional Tricuspid Regurgitation Phase 3
Terminated NCT04665583 - Prehab Prior to Undergoing Tricuspid Intervention
Recruiting NCT06307262 - European Registry of Transcatheter Repair for Tricuspid Regurgitation
Completed NCT02981953 - TRI-REPAIR: TrIcuspid Regurgitation RePAIr With CaRdioband Transcatheter System N/A
Recruiting NCT04433065 - TTVR Early Feasibility Study N/A
Not yet recruiting NCT05556460 - Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation N/A
Recruiting NCT05667519 - Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation (PLACE) N/A
Recruiting NCT04653428 - German Registry for Transcatheter Tricuspid Valve Interventions
Recruiting NCT05179616 - Pforzheim Tricuspid Valve Registry - Outcomes of Percutaneous Tricuspid Valve Repair
Completed NCT02644616 - The Safety and Efficacy of Tolvaptan for Patients With Tricuspid Regurgitation and Right Heart Failure After Left Heart Valves Replacement Phase 4
Recruiting NCT05328284 - PASCAL for Tricuspid Regurgitation - a European Registry
Not yet recruiting NCT05848284 - Clinical Safety and Efficacy of the VDyne Transcatheter Tricuspid Valve Replacement System for the Treatment of Tricuspid Regurgitation ( VISTA-US) Phase 1
Active, not recruiting NCT02675244 - Evaluating the Benefit of Concurrent Tricuspid Valve Repair During Mitral Surgery N/A
Recruiting NCT05436028 - A Study to Evaluate the Safety and Performance of LuX-Valve Plus System for Tricuspid Replacement N/A