Clinical Trials Logo
  1. Home
  2. Congestive Heart Failure
  3. NCT04955184
  4. Details
NCT04955184 Clinical Trial

Comparing Cardiac Output Measurements Using a Wearable, Wireless, Non-invasive PPG-Based Device to a Swan Ganz Catheter

Congestive Heart Failure Clinical Trial

Official title:
Comparing Cardiac Output Measurements Using a Wearable, Wireless, Non-invasive PPG-Based Device to a Swan Ganz Catheter During Ambulatory Assessment of CHF Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04955184
Other study ID # CO-002-00
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 10, 2021
Est. completion date June 25, 2022

Study information
Verified date December 2021
Source Biobeat Technologies Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Invasive pulmonary capillary wedge pressure measurements using a Swan-Ganz catheter (SGC) is considered the gold standard for cardiac output (CO) monitoring. In this prospective study, we will compare CO measurements between a PPG-based wearable monitor and a SGC in ambulatory CHF patients.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date June 25, 2022
Est. primary completion date June 15, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility Inclusion Criteria: - Patients with CHF Exclusion Criteria: - Pregnant women - Pediatric patients - Inability to sign an informed consent form

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• non-invasive monitoring
non-invasive measurements of cardiac output

Locations
Country Name City State
Israel The Hadassah Ein Kerem Medical Center Jerusalem

Sponsors (2)
Lead Sponsor Collaborator
Biobeat Technologies Ltd. Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Comparison of cardiac output obtained by a non-unvasive device to the invasive method In each participant, a Swan-Ganz catheter will be inserted as part of their routine assessment, and cardiac output measurements will be compared with a non-invasive wearable and wireless PPG-based device. 2-4 hours per patient
See also
  Status Clinical Trial Phase
Terminated NCT04115735 - His Bundle Recording From Subclavian Vein
Recruiting NCT05562037 - Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA N/A
Completed NCT05563701 - Evaluation of the LVivo Image Quality Scoring (IQS)
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Completed NCT04037436 - Functional Exercise and Nutrition Education Program for Older Adults N/A
Recruiting NCT04703842 - Modulation of SERCA2a of Intra-myocytic Calcium Trafficking in Heart Failure With Reduced Ejection Fraction Phase 1/Phase 2
Terminated NCT05594940 - Heart Failure Monitoring With a Portable Ultrasound Device With Artificial Intelligence Assisted Tools: A Multi-Phase Observational Feasibility Study
Recruiting NCT04982081 - Treating Congestive HF With hiPSC-CMs Through Endocardial Injection Phase 1
Completed NCT04394754 - Evaluating Efficacy of Digital Health Technology in the Treatment of Congestive Heart Failure N/A
Active, not recruiting NCT01385176 - Neural Cardiac Therapy for Heart Failure Study (NECTAR-HF) N/A
Not yet recruiting NCT05516290 - Evaluating Clinical Trial Experiences of Individuals With Congestive Heart Failure
Terminated NCT02788656 - Pulmonary Artery Pressure Reduction With ENTresto (Sacubitril/Valsartan) Phase 4
Completed NCT02885636 - Inhaled Beta-adrenergic Agonists to Treat Pulmonary Vascular Disease in Heart Failure With Preserved EF (BEAT HFpEF): A Randomized Controlled Trial Phase 3
Terminated NCT02205411 - Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation N/A
Completed NCT02252757 - Assess Measurements of Wireless Cardiac Output Device N/A
Completed NCT01362855 - Advance Care Planning Evaluation in Hospitalized Elderly Patients
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Withdrawn NCT00346177 - Stem Cell Study for Patients With Heart Failure Phase 2
Active, not recruiting NCT01058837 - SCD-HeFT 10 Year Follow-up N/A
Completed NCT00957541 - Evaluation of a Diagnostic Feature in a Cardiac Resynchronization Therapy (CRT) Device Phase 2