NCT06103539

Pacertool Early Feasibility Study - Safety and Performance

Pacertool-Study - Safety and Performance of the Presens-Catheter and the Pacer Software

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Pacertool AS · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study is a non-randomized, two-part, open label, prospective single-site, single arm, safety and performance study. The study is designed to collect acute and long-term clinical data and user reported outcome data from using the PreSens-Catheter and PACER Software during cardiac catheterization and Cardiac Resynchronization Therapy (CRT) device implantation procedures. Subjects with indication for arterial catheterization and CRT will be included.

Detailed description

The study consists of two parts: 1. Initial safety assessment: at least 5 patients undergoing coronary angiography or left heart catheterization and 5 patients undergoing cardiac resynchronization therapy device implantation to demonstrate acute safety and performance of the PreSens-Catheter and the PACER Software for Td measurements. 2. Safety and performance assessment: At least 35 patients with an indication for CRT implantation according to standard of care to demonstrate acute safety and performance of using the PreSens-Catheter and the PACER Software to measure Td and detect Synergy and Dyssynergy from multisite stimulation, and its utility to deliver measurements for the discrimination of two clinical cardiac reverse volumetric remodeling phenotypes based on Synergy and Dyssynergy in the targeted population. Subjects will be followed for the duration of the procedure up to 24 hours for any serious adverse events, and subjects receiving a CRT device will be followed for 30 days follow-up for procedure or device-related events and for up to 6 months for cardiac volumetric remodeling phenotyping. Clinical outcomes: Clinical outcome will be measured as Safety for the placement of the PreSens-Catheter, safety for the PreSens-Catheter and PACER Software combined for the measurement of Td and detection of Synergy/ Dyssynergy from stimulation, and diagnostic/ predictive performance of the PreSens-Catheter and PACER Software with the measurement of end-systolic volume at 6-months follow-up.

Conditions

• Heart Failure With Reduced Ejection Fraction
• Dyssynchrony
• Medical Device Performance

Interventions

Type	Name	Description
DEVICE	Cardiac catheterization and evoked response to cardiac stimulation	Cardiac catheterization with a combined elecrtophysiology and pressure sensing catheter to perform multisite stimulation and measure the evoked pressure response in a connected software.

Timeline

• Start date: 2023-12-01
• Primary completion: 2024-09-01
• Completion: 2024-12-30
• First posted: 2023-10-26
• Last updated: 2023-10-26

Locations

1 site across 1 country: Georgia