Pneumatic Sleeves and Congestive Heart Failure | NCT01691417

Studies
Pneumatic Sleeves and Congestive Heart Failure

NCT01691417

Sponsor

Western Galilee Hospital-Nahariya

Status

Completed

Last Update Posted

Sep 24, 2012Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Congestive Heart Failure

Interventions

Intermittent Sequntial Pnumatic Compression Leg Sleeves

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

Sep 2012

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

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 9, 2012

First Submission Date that Met QC Criteria

Sep 19, 2012

First Posted Date

Sep 24, 2012Estimated

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

Sep 19, 2012

Last Update Posted Date

Sep 24, 2012Estimated

Description Module

Brief Summary

Based on the reversal of the adverse cardiovascular parameters during Laproscopic Surgery and its influence on cardiac activity in healthy subjects, the investigators expect to improved cardiac function in patients suffering from congestive heart failure.

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

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pneumatic Sleeves	Experimental		Device: Intermittent Sequntial Pnumatic Compression Leg Sleeves
Congestive Heart Failure Patients	Experimental		Device: Intermittent Sequntial Pnumatic Compression Leg Sleeves

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intermittent Sequntial Pnumatic Compression Leg Sleeves	Device		Congestive Heart Failure Patients Pneumatic Sleeves

Measure	Description	Time Frame
Cardiac Output

Measure	Description	Time Frame
Systemic vascular resistance

Measure	Description	Time Frame
Stroke volume

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CHF (as clinically evaluated and asessed by TTE)
Gave informed consent
NYHA Class II-III
LVEF equal or less than 40%

Exclusion Criteria:

Patients who could not sign informed consent
NYHA Class IV
Oxygen saturation less than 90% under room air

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases