Establishing Correlation Between Non-invasive Pulmonary B... | NCT04509089

Studies
Establishing Correlation Between Non-invasive Pulmonary Blood Pressure Readings and Swan-Ganz Results

NCT04509089

Sponsor

Suremedix Ltd

Status

Completed

Last Update Posted

Aug 4, 2021Actual

Enrollment

15Actual

Phase

Not Applicable

Conditions

Congestive Heart Failure

Interventions

Suremedix Device

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2020Actual

Primary Completion Date

Jan 29, 2021Actual

Completion Date

Mar 1, 2021Actual

First Submitted Date

Aug 8, 2020

First Submission Date that Met QC Criteria

Aug 10, 2020

First Posted Date

Aug 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 28, 2021

Last Update Posted Date

Aug 4, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Pulmonary hypertension (PH) is prognostic indicator in heart failure patients for poor outcome, however, it is challenging for monitoring. The current study is designed to explore whether data generated using Suremedix Device including a pump and non-invasive sensors including, chest motion sensor, photoplethysmography (PPG), and Electrocardiography (ECG), can be used to identify detectable oscillations that are correlated with the mean, the diastolic and the systolic pressure values of the pulmonary artery, as measured using the gold-standard Swan-Ganz method.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental	Experimental	Congestive heart failure patients scheduled for pulmonary artery catheterization (Swan-Ganz)	Device: Suremedix Device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Suremedix Device	Device	Performing measurements using the Suremedix Device by applying gradually ascending air pressure to the subject lungs through a mouse piece while measuring respiratory chest motion, PPG and ECG.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pressure waveform	Correlation between specific changes observed in the pressure waveform recorded by the SureMedix Device and the mean, diastolic and systolic pressure values of the pulmonary artery as measured using the gold-standard Swan-Ganz method.	15 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Heart Failure patient scheduled for right heart catheterization (Swan-Ganz)
Age range: 18 - 80 years
Pulmonary artery systolic pressure values ≤50 mmHg according to Swan - Ganz measurement
Able and willing to sign informed consent

Exclusion Criteria:

History or current diagnosis of asthma or any other significant pulmonary disease
Jugular access site
Atrial fibrillation
Prior lung volume reduction surgery, lobectomy or pneumonectomy, or lung transplantation
Requirement for any ventilator support (including CPAP or BPAP)
Use of long-term oxygen therapy
Known upper airway obstruction
Known susceptibility to pneumothorax or pneumothorax in the medical history
Chest surgery or pacemaker implantation in the prior 6 months
Significant primary valvular disease
Major cardiovascular event within the prior 3 months
Current heavy smoker (more than one pack per day)
Any diagnosed respiratory tract infection (including upper respiratory tract), airway or lung disease or COPD exacerbation in the prior 3 months
Female patient pregnant or breast-feeding or planning to be pregnant in the next year
Diagnosis of Obstructive Sleep Apnea
Unexplained muscle weakness. Unable to comfortably lie down for 30 minutes
Current hospitalization due to CHF deterioration
Patients with a Body Mass Index (BMI) ≥ 40kg/m2
Any condition that the PI believes could interfere with the intent of the study or would make participation not in the best interest of the patient

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases