TRICuspid Intervention and Invasive Hemodynamic Monitoring in Heart Failure

Summary

Tricuspid regurgitation (TR) is a severe and highly prevalent disease that leads to right-sided heart failure. The severity of TR is associated with increasing morbidity and mortality. While severe TR and right-sided heart failure have an impact on the quality of life and prognosis of the individual patient, repeat heart failure hospitalizations challenge limited hospital resources on an institutional level and stress the medical health care system on an economic level. Transcatheter valve interventions (TTVI) including transcatheter tricuspid edge-to-edge repair (T-TEER) and transcather tricuspid valve replacement (TTVR) have been established as effective techniques to safely reduce TR severity in many patients leading to significant improvements in quality-of-life and potential reduction of heart failure hospitalizations. However, the rate of heart failure hospitalizations remains elevated, despite technically successful TTVI. Accordingly, heart failure hospitalizations occur in approximately 15-20% of patients and often result in complicated and prolonged in-hospital treatments. Therefore, optimization of the heart failure management and reduction of post-procedural heart failure hospitalizations are unmet needs in patients after TTVI.

Implantable pulmonary artery (PA) pressure sensing (IPAPS) is a novel strategy to improve heart failure management and to reduce heart failure hospitalizations. Continuous PA pressure monitoring provides an early indication of worsening heart failure trends and allows for the guidance of medical management to prevent unplanned hospitalizations. So far, this technology has been predominantly studied in patients with left-sided heart failure. The performance of PA pressure monitoring in right-sided heart failure is understudied. Also, the changes of PA pressure levels in response to TTVI has not yet been investigated. Heart failure hospitalizations in patients with right-sided heart failure are caused by gradual fluid overload resulting in shortness of breath, weight gain, peripheral edema, and ascites. Fluid overload will lead to a simultaneous increase of PA pressure, and therefore, may also be identified early by IPAPS in right-sided heart failure patients. The Cordella PA Sensor System has been designed for multi-parametric heart failure telemonitoring including PA pressure and other vital signs. In clinical trials, the Cordella PA Sensor System demonstrated a significantly lower heart failure hospitalization and all-cause mortality event rate in NYHA class III heart failure patients, when compared to historical PA pressure studies. IPAPS was associated with significant improvements in quality-of-life metrics, while complication rates were low. The Cordella PA Sensor System is expected to receive CE-marking in 2025. The proposed study will be initiated after CE-mark approval, so that all patients will be treated with CE-marked devices and on-label.

In this study we will assess the applicability of PA pressure monitoring using the Cordella Sensor device in patients with severe TR undergoing T-TEER or TTVR (n=30 patients). Included patients will undergo right-heart catheterization for evaluation of TR as indicated by clinical routine practice before TTVI. During right heart catheterization, patients receive implantation of the Cordella Sensor device. Thereafter, PA pressure will be monitored for approximately 4 weeks prior to TTVI. Subsequently, patients undergo T-TEER or TTVR as indicated and recommended by the heart team. PA pressure telemonitoring will be continued after TTVI. The change in PA pressure before TTVI compared to the first month after TTVI will be reported as primary endpoint in this pilot study. The performance of the Cordella PA Sensor System in right-sided heart failure patients for remote heart failure monitoring will be assessed over a 12-month follow-up period as the main secondary endpoint.

The concept of IPAPS has the potential to significantly improve the post-procedural heart failure management in patients after TTVI. The proposed pilot study will serve as base for the development of a larger clinical trial evaluating the concept of PA telemonitoring for improving outcomes in patients with severe tricuspid regurgitation and right-sided heart failure.

In an adjunct feasibility study, an implantable pulmonary artery pressure sensor (IPAPS) will be implanted off-label in the hepatic vein to evaluate a sensitive heart failure monitoring strategy in patients with right-sided heart failure (n = 15).

Conditions

• Heart Failure With Severe Tricuspid Regurgitation

Interventions

DEVICE

Pulmonary artery sensor system

PA pressures will be monitored before and after TTVI by CE-certified PA Sensor System

Sponsors & Collaborators

• LMU Klinikum

  lead OTHER

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-17

Primary Completion

2029-03-31

Completion

2029-03-31

Countries

• Germany

Study Locations