RecruitingNCT05179616

Pforzheim Tricuspid Valve Registry - Outcomes of Percutaneous Tricuspid Valve Repair

Pforzheim Tricuspid Valve Registry: A Real-world Observational Trial Evaluating Outcomes in Patients Treated With the Abbott TriClip™ Device in Helios Klinikum Pforzheim


Sponsor

Helios Klinikum Pforzheim

Enrollment

200 participants

Start Date

Nov 30, 2020

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria1

  • Subjects participating in another clinical study that may impact the follow-up or results of this study.

Interventions

PROCEDURETranscatheter edge-to-edge tricuspid valve repair

Percutaneous edge to edge repair of tricuspid valve using the TriClip system


Locations(1)

Helios Klinikum Pforzheim

Pforzheim, Germany

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NCT05179616


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