Pforzheim Tricuspid Valve Registry - Outcomes of Percutaneous Tricuspid Valve Repair

Tricuspid Regurgitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05179616
• Other study ID #: PF-TriValve
• Status: Recruiting
• Start date: November 30, 2020
• Est. completion date: November 30, 2026

Study information

• Verified date: September 2023
• Source: Helios Klinikum Pforzheim
• Contact: Ilka Ott, MD, PhD
• Phone: +4972319692955
• Email: Ilka.Ott[@]helios-pforzheim.de
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: November 30, 2026
• Est. primary completion date: November 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Remodeling
• Cardiac Remodeling, Atrial
• Cardiac Remodeling, Ventricular
• Right Heart Failure
• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency
• Ventricular Remodeling

Intervention

Procedure:
• Transcatheter edge-to-edge tricuspid valve repair
Percutaneous edge to edge repair of tricuspid valve using the TriClip system

Locations

Country	Name	City	State
Germany	Helios Klinikum Pforzheim	Pforzheim

Sponsors (1)

Lead Sponsor	Collaborator
Helios Klinikum Pforzheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedural Success	One-grade reduction of tricuspid regurgitation	at 12 months
Secondary	Change in quality of life	NYHA class	at 12 months
Secondary	Change in functional capacity	6-minute walk test	at 12 months
Secondary	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