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
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 |
Verified date | December 2021 |
Source | Biobeat Technologies Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Israel | The Hadassah Ein Kerem Medical Center | Jerusalem |
Lead Sponsor | Collaborator |
---|---|
Biobeat Technologies Ltd. | Hadassah Medical Organization |
Israel,
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 |
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 | |
Completed |
NCT02252757 -
Assess Measurements of Wireless Cardiac Output Device
|
N/A | |
Terminated |
NCT02205411 -
Clinical Trial to Evaluate the the ReliantHeart HeartAssist 5® VAD System in Patients Awaiting Heart Transplantation
|
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 |