Pforzheim Tricuspid Valve Registry - Outcomes of Percutaneous Tricuspid Valve Repair
1 other identifier
observational
200
1 country
1
Brief Summary
The Pforzheim Tricuspid Valve Registry study is designed to confirm the safety and performance of the TriClip™ device in a contemporary real-world setting in critically ill patients. The observational trial is a prospective, single arm, open-label, single-center, post market registry.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 30, 2020
CompletedFirst Submitted
Initial submission to the registry
November 27, 2021
CompletedFirst Posted
Study publicly available on registry
January 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2026
ExpectedSeptember 22, 2023
September 1, 2023
5 years
November 27, 2021
September 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Procedural Success
One-grade reduction of tricuspid regurgitation
at 12 months
Secondary Outcomes (3)
Change in quality of life
at 12 months
Change in functional capacity
at 12 months
Major organ system functional change
at12 months
Study Arms (1)
Heart Failure Patients
Patients suffering from symptoms of right heart failure due to high-grade tricuspid regurgitation
Interventions
Percutaneous edge to edge repair of tricuspid valve using the TriClip system
Eligibility Criteria
All subjects who have symptomatic severe tricuspid regurgitation despite medical therapy and are eligible to receive the TriClip™
You may qualify if:
- Subjects (\>=18 years age) have severe tricuspid regurgitation and are symptomatic despite medical therapy.
- Subjects eligible to receive the TriClip™
- Subjects must provide written informed consent prior to study procedure.
You may not qualify if:
- Subjects participating in another clinical study that may impact the follow-up or results of this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Helios Klinikum Pforzheim
Pforzheim, 75175, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ilka Ott, MD, PhD
Helios Klinikum Pforzheim
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 12 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 27, 2021
First Posted
January 5, 2022
Study Start
November 30, 2020
Primary Completion
November 30, 2025
Study Completion (Estimated)
November 30, 2026
Last Updated
September 22, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share