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

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.

Study Overview

• Status: Recruiting
• Conditions: Right Heart Failure; Tricuspid Regurgitation; Cardiac Remodeling, Ventricular; Cardiac Remodeling, Atrial
• Intervention / Treatment: Procedure: Transcatheter edge-to-edge tricuspid valve repair

Detailed Description

Significant tricuspid regurgitation is a common finding in elderly patients, with an incidence of 5.6% after the age of 70 years, according to the Framingham Heart Study. TR is an independent predictor for adverse prognosis and has limited treatment options. Tricuspid valve (TV) intervention is indicated when symptomatic TR-related right heart failure (RHF) is present. However, the surgical risk is usually deemed to be too high due to the presence of advanced age, pulmonary hypertension, right ventricular (RV) impairment, major organ failure and other co-morbidities. Moreover, isolated tricuspid valve surgery has an in-hospital mortality of approx. 8,7%, according to recent data.

High TR prevalence, coupled with low incidence of isolated TV surgery, has created a considerable population in need of alternative, percutaneous therapies to improve outcomes. Recently, a variety of interventional procedures and devices have been developed which simulate different surgical approaches like suture or ring annuloplasty, coaptation enhancement, neochordae repair, or even valve replacement. Among them, coaptation devices attempt to correct leaflet malcoaptation by using the edge-to-edge clip technique, similar to treatment of functional mitral regurgitation. To date, most TTVR interventions have been performed off-label with the MitraClip device.

Last year, the first TR dedicated device (TriClipTM, Abbott Medical) has been approved (CE mark), after showing good feasibility, safety and effectiveness, and meanwhile sustained and marked clinical benefit with low mortality after 12 months.

Although most TTVR studies have enrolled high-risk cohorts, criteria for patient selection and timing of intervention have yet to be defined. Based on scientific surgical data, it seems reasonable to expect poorer outcomes in patients with several comorbidities, advanced cardiac remodeling and RHF-related major organ dysfunction e.g., renal and hepatic function impairment. Whether or not this assumption can be extrapolated to TTVR needs to be investigated.

In this registry, the investigators aim to evaluate if percutaneous therapy with the TriClip system is safe and effective in patients at high and prohibitive risk and wether or not procedural success is the main determinant of short-, mid- and long-term outcomes.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Ilka Ott, MD, PhD; Phone Number: +4972319692955; Email: Ilka.Ott@helios-pforzheim.de
• Study Contact Backup: Name: Alexandru Patrascu, MD; Phone Number: +491736964480; Email: alexbasket23@yahoo.com

Study Locations

• Germany
  • Pforzheim, Germany, 75175
    • Recruiting
    • Helios Klinikum Pforzheim
    • Contact: Alexandru Patrascu, MD; Phone Number: +491736964480; Email: alexbasket23@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All subjects who have symptomatic severe tricuspid regurgitation despite medical therapy and are eligible to receive the TriClip™

Description

Inclusion Criteria:

• 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 Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Heart Failure Patients; Patients suffering from symptoms of right heart failure due to high-grade tricuspid regurgitation	Procedure: Transcatheter edge-to-edge tricuspid valve repair; Percutaneous edge to edge repair of tricuspid valve using the TriClip system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural Success	One-grade reduction of tricuspid regurgitation	at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life	NYHA class	at 12 months
Change in functional capacity	6-minute walk test	at 12 months
Major organ system functional change	Renal and hepatic function as assessed by following lab values: creatinine, glomerular filtration rate, aspartate transaminase, alanine aminotransferase and bilirubine	at12 months

Collaborators and Investigators

• Sponsor: Helios Klinikum Pforzheim
• Investigators: Principal Investigator: Ilka Ott, MD, PhD, Helios Klinikum Pforzheim

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2020
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: November 27, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Valve Diseases; Tricuspid Valve Insufficiency; Ventricular Remodeling; Atrial Remodeling
• Other Study ID Numbers: PF-TriValve

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No