Cardiac Performance System Data Collection Study - Minnesota

• Sponsor: Sensydia Corporation (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT06149143
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 3.9
• Patients Per Site Per Month: 12.7

Study Details

Study Description

Brief Summary

Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

Condition or Disease	Intervention/Treatment	Phase
Cardiac Disease	Device: Cardiac Performance System (NSR)

Detailed Description

Non-significant risk device study to conduct evaluation of the performance of new device for monitoring of cardiac function (based on previous iterations 510(k) 173156)

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Cardiac Performance System Data Collection Study - Minnesota
• Actual Study Start Date: Oct 3, 2023
• Anticipated Primary Completion Date: Jan 31, 2024
• Anticipated Study Completion Date: Jan 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Cardiac Function Monitoring Subjects scheduled for cardiac catheterization will undergo measurement with the Cardiac Performance System non-invasive device for a brief period before the catheterization procedure.	Device: Cardiac Performance System (NSR); Participants will be asked to wear the Cardiac Performance System, a non-invasive sensor device on their upper abdomen. The Cardiac Performance System monitoring device will continuously monitor cardiac function.

Outcome Measures

Primary Outcome Measures

1. Cardiac Performance System electronic data for Cardiac Output [10 minutes before cardiac catheterization procedure]

   Cardiac function metric measurement including Cardiac Output to report in L/m.

2. Cardiac Performance System electronic data for Pulmonary Artery Pressure [10 minutes before cardiac catheterization procedure]

   Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.

3. Cardiac Performance System electronic data for Pulmonary Capillary Wedge Pressure [10 minutes before cardiac catheterization procedure]

   Cardiac function metric measurement including Pulmonary Capillary Wedge Pressure to report in mmHg.

4. Pulmonary Artery Catheter electronic data for Cardiac Output [60 minutes during cardiac catheterization procedure]

   Cardiac function metric measurement including Cardiac Output to report in L/m.

5. Pulmonary Artery Catheter electronic data for Pulmonary Artery Pressure [60 minutes during cardiac catheterization procedure]

   Cardiac function metric measurement including Pulmonary Artery Pressure to report in mmHg.

6. Pulmonary Artery Catheter electronic data for Pulmonary Capillary Wedge Pressure [60 minutes during cardiac catheterization procedure]

   Cardiac function metric measurement including Pulmonary Capillary Wedge Pressure to report in mmHg.

7. Echocardiography electronic data for Ejection Fraction [15 minutes at a time prior to or after Pulmonary Artery Catheter procedure]

   Cardiac function measurement including left ventricle ejection fraction to report in percentage.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 22 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Ability to provide written informed consent

• 22 years of age or older

• Referred for cardiac catheterization for reasons including heart failure, evaluation before transplant, pulmonary hypertension, shortness of breath, valvular disease, etc.

Exclusion Criteria:

• Previous Heart Transplant

• Presence of Left Ventricular Assist Device

• Presence of a Holter monitor or any other electrical leads on the chest at the time of sensor placement

• Surgical scars/wounds/bandages/ports at the site of sensor placement

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• Sensydia Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sensydia Corporation
• ClinicalTrials.gov Identifier: NCT06149143
• Other Study ID Numbers: CPS_MINNESOTA
• First Posted: Nov 28, 2023
• Last Update Posted: Nov 28, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Diseases

Study Results

No Results Posted as of Nov 28, 2023