Clinical trial NCT05179616: Pforzheim Tricuspid Valve Registry - Outcomes of Percutaneous Tricuspid Valve Repair
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tricuspid Regurgitation
Right Heart Failure
Cardiac Remodeling, Ventricular
Cardiac Remodeling, Atrial
Lead sponsor: Helios Klinikum Pforzheim
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All subjects who have symptomatic severe tricuspid regurgitation despite medical therapy and are eligible to receive the TriClip™

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Procedural Success
timeFrame: at 12 months
Secondary outcomes:
measure: Change in quality of life
timeFrame: at 12 months
measure: Change in functional capacity
timeFrame: at 12 months
measure: Major organ system functional change
timeFrame: at12 months
Other outcomes:
Locations:
city: Pforzheim
country: Germany
facility: Helios Klinikum Pforzheim
Study officials:
affiliation: Helios Klinikum Pforzheim
name: Ilka Ott, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: