Acute Impact of the Impella CP Assist Device in Pts. With... | NCT04451798

Studies
Acute Impact of the Impella CP Assist Device in Pts. With Cardiogenic Shock on the Patients Hemodynamic

NCT04451798

Sponsor

University of Leipzig

Status

Unknown status

Last Update Posted

Nov 1, 2022Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Cardiogenic Shock

Interventions

Impella CP microaxial pump

Countries

Germany

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

Oct 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2016Actual

Primary Completion Date

Dec 2022Estimated

Completion Date

Mar 2023Estimated

First Submitted Date

Mar 1, 2020

First Submission Date that Met QC Criteria

Jun 25, 2020

First Posted Date

Jun 30, 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

Oct 31, 2022

Last Update Posted Date

Nov 1, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sven Möbius-Winkler, Principal Investigator, Clinical Professor, University of LeipzigPrincipal Investigator

Lead Sponsor

University of LeipzigOTHER

Collaborators

Name	Class
Jena University Hospital	OTHER

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Prospective, monocentric open-label observational study for the assessment of acute hemodynamic effects following implantation of the IMPELLA CP cardiac support device

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Impella implantation and hemodynamic measurement	Device: Impella CP microaxial pump

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Impella CP microaxial pump	Device	ramp test	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hemodynamic Parameters due to PA catheterisation	Pulmonary capillary Wedge pressure in dependence of Impella pump level	Day 1
Echocardiographic Parameters of left and right heart function	LV- size in dependence of Impella pump level	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cardiogenic shock following acute MI or acute heart failure with
- systolic BP < 90 mm Hg over > 30 min or inotropes for support of cardiac output and BP with
- signs of left heart failure and pulmonary congestion
- and end-organ hypo perfusion with somnolence or cold, pale skin, or oliguria or serum lactate >2 mmol/l

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

91 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
SWven Möbius-Winkler, MD	Contact	0049-3641-9324503		sven.moebius-winkler@med.uni-jena.de
Christian P Schulze, MD	Contact	0049-3641-9324103		christian.schulze@med.uni-jena.de

Overall Officials

Name	Affiliation	Role
Sven Möbius-Winkler, MD	Universityhospital Jena	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Jena	Recruiting	Jena		07747	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012770	Shock, Cardiogenic

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided