- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01691417
Pneumatic Sleeves and Congestive Heart Failure (Sleeves-Bickel)
September 19, 2012 updated by: Western Galilee Hospital-Nahariya
The Impact of Intermittent Sequential Pneumatic Compression (ISPC) Leg Sleeves on Cardiac Performance in Patients With Congestive Heart Failure
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Nahariya, Israel, 22100
- Western Galilee Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Pneumatic Sleeves
|
|
|
Experimental: Congestive Heart Failure Patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Cardiac Output
|
Secondary Outcome Measures
Outcome Measure |
|---|
|
Systemic vascular resistance
|
Other Outcome Measures
Outcome Measure |
|---|
|
Stroke volume
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
September 9, 2012
First Submitted That Met QC Criteria
September 19, 2012
First Posted (Estimate)
September 24, 2012
Study Record Updates
Last Update Posted (Estimate)
September 24, 2012
Last Update Submitted That Met QC Criteria
September 19, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Sleeves-Bickel
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Congestive Heart Failure
-
Indiana UniversityRecruitingCongestive Heart Failure | Congestive Heart Failure (CHF) | Congestive Heart Failure Chronic | Congestive Heart Failure(CHF)United States
-
Adnan Kastrati, MDBiotronik SE & Co. KGCompleted
-
Signature Medical, Inc.WithdrawnHeart Failure,Congestive
-
ELA Medical, Inc.Approved for marketing
-
Echosense Ltd.WithdrawnCongestive Heart Failure (CHF)United States
-
Corthera, Inc.(formerly BAS Medical, Inc.), a member...TerminatedCongestive Heart Failure (CHF)Russian Federation
-
Meir Medical CenterUnknown
-
Nihon KohdenTerminatedHeart Failure,CongestiveUnited States
-
Magenta Medical Ltd.TerminatedCongestive Heart Failure | Heart Failure, Congestive | Acute Heart FailureCroatia, Belgium, Serbia
-
Ageless Regenerative InstituteInstituto de Medicina RegenerativaWithdrawnNon-Ischemic Congestive Heart FailureMexico
Clinical Trials on Intermittent Sequntial Pnumatic Compression Leg Sleeves
-
Cardinal HealthRecruitingHemodynamicsUnited States
-
Walter Reed National Military Medical CenterWithdrawnEkbom Syndrome | Restless Legs Syndrome, | Restless Legs,United States