TRICuspid Intervention and Invasive Hemodynamic Monitoring in Heart Failure (TRIC-I-HF 2)

Heart Failure Monitoring Using Continuous Pulmonary Arterial or Central Venous Pressure Measurement in Patients Undergoing Transcatheter Tricuspid Valve Intervention: a Pilot and Feasability Study

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).

Study Overview

• Status: Recruiting
• Conditions: Heart Failure With Severe Tricuspid Regurgitation
• Intervention / Treatment: Device: Pulmonary artery sensor system

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Stocker, MD; Phone Number: +498944000; Email: thomas.stocker@med.uni-muenchen.de
• Study Contact Backup: Name: Jörg Hausleiter; Email: joerg.hausleiter@med.uni-muenchen.de

Study Locations

• Germany
  • Munich, Germany
    • Not yet recruiting
    • LMU Klinikum
    • Contact: Jörg Hausleiter, MD; Email: joerg.hausleiter@med.uni-muenchen.de
    • Contact: Thomas Stocker, MD; Phone Number: +498944000; Email: thomas.stocker@med.uni-muenchen.de
  • München, Germany
    • Recruiting
    • LMU Munich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥18 years
• Heart-failure NYHA class III despite optimal medical therapy
• Heart failure related hospitalization in the 12 month prior to Cordella PA pressure sensor system implant
• Planned tricuspid transcatheter edge-to-edge repair (T-TEER) or transcatheter tricuspid valve replacement (TTVR)
• Willingness to participate and sign informed consent
• Ability to perform PA pressure reading and telemonitoring

Exclusion Criteria:

• Cardiogenic shock or hemodynamic instability
• Previous tricuspid intervention or surgery with repair or replacement of tricuspid leaflets
• Active endocarditis
• Tricuspid valve stenosis (baseline tricuspid valve in-flow gradient > 5 mmHg)
• Life expectancy of less than 12 months
• Chronic renal failure requiring dialysis
• Anatomic conditions impeding implantation of PA sensor
• Acute pulmonary embolism or chronic thromboembolic pulmonary Hypertension (CTEPH)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient scheduled for tricuspid intervention; Implantation of pulmonary artery sensor system before tricuspid intervention	Device: Pulmonary artery sensor system; PA pressures will be monitored before and after TTVI by CE-certified PA Sensor System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in implantable pulmonary artery (PA) pressure sensing (IPAPS) before TTVI compared to one month after TTVI	1 month post tricuspud intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality	1, 6, and 12 months after TTVI
Heart failure hospitalizations	1, 6, and 12 months after TTVI
Days alive out of hospital at 12 months	1, 6, and 12 months after TTVI
Change in echocardiographic parameters, in specific TR grade	1, 6, and 12 months after TTVI
Change in laboratory markers for cardiac function, pro-BNP value	1, 6, and 12 months after TTVI
Change in laboratory markers for renal function, eGFR value	1, 6, and 12 months after TTVI
Change in laboratory markers for hepatic function, bilirubin value	1, 6, and 12 months after TTVI
Myocardial infarction, pulmonary embolism, and stroke	1, 6, and 12 months after TTVI
Bleeding events according to VARC classification	1, 6, and 12 months after TTVI
Change of diuretic drugs and heart failure medications	1, 6, and 12 months after TTVI
Patient adherence to IPAPS (frequency of transmissions)	1, 6, and 12 months after TTVI
Change in IPAPS at 6, and 12 month post TTVI compared to baseline before TTVI	1, 6, and 12 months after TTVI
Changes of IPAPS in association to clinical improvement post TTVI (NYHA class, physical activity, 6-MWDT, QoL)	1, 6, and 12 months after TTVI

Collaborators and Investigators

• Sponsor: LMU Klinikum

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: February 17, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Heart failure; Tricuspid regurgitation; Transcatheter tricuspid intervention; PA sensor; Remote hemodynamic management
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Heart Failure; Tricuspid Valve Insufficiency
• Other Study ID Numbers: TRIC-I-HF 2

Drug and device information, study documents

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