The study for evaluation of acute phase safety and efficacy of ‘Pivot Bridge’ to short-term treat Functional Tricuspid Regurgitation : multi-center, open label, single arm, investigator initiated exploratory pilot study

Not Applicable

Completed

• Conditions: Diseases of the circulatory system

• Registration Number: KCT0008449
• Lead Sponsor: Samsung Medical Center

Brief Summary

An exploratory clinical trial of the Pivot Bridge was conducted from December 1, 2022, through December 29, 2023, following the approval of the protocol. A total of 15 participants were enrolled in the study, with a mean time from puncture to insertion of the investigational device of 47±23 minutes. Other than minor adverse events, no serious adverse events related to the medical device have been reported. the positioning, function, and reduction in TR of the 3D spacer remained intact, and the implant remained implanted without any adverse events in the IVC, tricuspid valve area, or otherwise. For the secondary efficacy endpoint of TR grade reduction, all 15 participants achieved at least an improvement of TR grade 1 immediately post-treatment. EROA decreased from baseline (1.2±0.5cm2) to end point (0.6±0.3cm2), and the vena contracta width decreased from baseline (1.6±0.5cm) to end point (0.8±0.3cm). All of these results were significant at P<0.001. The TR grades were also improved from baseline ("Torrential" 46.7%, "Massive" 40.0%, and "Severe" 13.3%) to the endpoint ("Massive" 20.0%, "Severe" 46.7%, "Moderate" 26.7%, and "Mild" 6.7%). The hemanalysis showed that the eGFR of the 15 participants increased from baseline (67.8±23.3 ml/min/1.73) to the endpoint (77.9±26.7 ml/min/1.73), with a P<0.004 significance. The body weight decreased from baseline (62.8±9.5 kg) to the endpoint (61.3±9.3 kg), P<0.08. The changes in eGFR and body weight indicated a 10% improvement in renal function and a 1.5 kg reduction in peripheral edema. Echocardiography showed an 8.1% decrease in right ventricular volume from baseline (320.2±93.7 mL) to the endpoint (294.4±81.1 mL) and a 10.2% decrease in tricuspid annulus area from baseline (21.5±5.0 cm2) to the efficacy endpoint (19.3±2.7 cm2).

Detailed Description

Not available

Study Timeline

• Study Completion: 2024-06-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1) Adult males and females aged 20 years or above.
2) Patients with clinical symptoms whose tricuspid regurgitation using echocardiography corresponds to Severe or higher criteria presented in the classification table of TR grade.
3) Short-term treatment using catheters is required (expected to be effective) in the Local Site Heart Team, which includes at least one cardiologist and cardiothoracic surgeon, respectively, and falls under NYHA Class II or higher clinical symptoms.
4) Individuals exhibiting a potential reduction in TR on the screening test via insertion of a balloon-like device (e.g., ASD sizing balloon, pivot balloon, etc.) through an identical approach as that used for the Pivot Bridge.”
5) Individuals who voluntarily agree to participation in the clinical trial and provide written informed consent.
6) Individuals with the ability to understand and comply with the instructions and who can participate in the pre-clinical trial procedures.

Exclusion Criteria

1) Uncontrolled hyperthyroidism
2) Recent formation of a soft blood clot or embolic material
3) Uncorrected coagulopathy
4) Prohibition of anticoagulant agents
5) Those who have used anticoagulants prior to participating in this clinical trial and have been treated with major bleeding (minor bleeding, such as hemostatic nosebleeds), or have severe anemia that requires inpatient treatment
6) Previous insertion of devices such as implantable cardioverter defibrillators (ICDs) or pacemakers
7) Low probability of reduction in TR through the insertion of a balloon-like device (e.g., ASD sizing balloon, pivot balloon, etc.) using a route identical to that used for Pivot Bridge” insertion on the screening test
8) Prohibition of device insertion based on anatomical structure
9) Pregnant or lactating mother, or a female patient planning pregnancy during the period of clinical trial, or a female not using an approved contraceptive with the possibility of pregnancy
10) Participation in another clinical trial 30 days prior to the screening
11) Individuals with clinical findings deemed unsuitable for the clinical trial by the Principal Investigator or the Investigator

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
death, myocardial infarction, cardiac tamponade, device related cardiac surgery, stroke, pulmonary embolism, New renal failure, severe bleeding, Device related infection, Thrombus, Re-intervention, Serious side effects requiring treatment of other treatment areas

Secondary Outcome Measures

Name	Time	Method
Pulmonary arterial forward flow (PW Doppler at the annulus level of the pulmonary valve), Right ventricular output (heart rate x RVOT area x RVOT TVI), fractional area change, peak systolic annular velocity, tricuspid annular plane systolic excursion, systolic flow reversal based on inferior vena cava diameter and PW tracing, Left ventricular volume,