A Multi-site, Pre-clinical, Prospective Data Collection Study in Patients Undergoing a Right Heart Catheterization

Not yet recruitingOBSERVATIONAL
Enrollment

392

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

March 31, 2026

Study Completion Date

May 30, 2026

Conditions
Heart Failure
Interventions
DEVICE

Data collection

A supervised session that includes 10 minutes of patient information entry, 5 minutes of sensor recording time and 10 minutes of margin for setting up the system and patient, thus a total evaluation duration of approximately 25 minutes prior to the Right Heart Catheterization. No follow-up period for the subjects will be required for this clinical investigation. Patients will be followed as per standard of care, at the hospital. A single follow-up observational data collection will be conducted at 90 days, to collect the number of unplanned hospitalizations since the procedure visit. This does not involve active patient participation.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Acorai AB

INDUSTRY

NCT07010562 - A Multi-site, Pre-clinical, Prospective Data Collection Study in Patients Undergoing a Right Heart Catheterization | Biotech Hunter | Biotech Hunter