Stimulation of the Diaphragm in Patients With Severe Hear... | NCT00769678

Studies
Stimulation of the Diaphragm in Patients With Severe Heart Failure Following Heart Surgery

NCT00769678

Sponsor

Luzerner Kantonsspital

Status

Completed

Last Update Posted

Apr 17, 2013Estimated

Enrollment

33Actual

Phase

Not Applicable

Conditions

Heart Failure

Interventions

Stimulation of the diaphragm

Countries

Switzerland

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

Apr 2013

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

Oct 2008

Primary Completion Date

May 2012Actual

Completion Date

Not provided

First Submitted Date

Oct 3, 2008

First Submission Date that Met QC Criteria

Oct 8, 2008

First Posted Date

Oct 9, 2008Estimated

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

Apr 16, 2013

Last Update Posted Date

Apr 17, 2013Estimated

Name	Class
Inovise Medical	INDUSTRY

Description Module

Brief Summary

This study examines whether a permanent stimulation of the diaphragm improves left ventricular function in patients with severe heart failure following heart surgery.

Detailed Description

Previous studies have shown that temporary stimulation of the diaphragm using an electrode to the phrenic nerve reduces electrical mechanical activation time (EMAT) and improves left ventricular function. This study examines whether patients with severe heart failure, who require permanent biventricular pacing after heart surgery, may benefit from an additional permanent electrode that stimulates the diaphragm. Heart function is assessed by echocardiography and acoustic cardiography (Audicor, Inovise Medical Inc., Portland, USA).

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

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stimulation of diaphragm	Active Comparator		Device: Stimulation of the diaphragm

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Stimulation of the diaphragm	Device	Stimulation of the diaphragm using an electrode	Stimulation of diaphragm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Left ventricular ejection fraction		One day

Secondary Outcomes

Measure	Description	Time Frame
Brain natriuretic peptide (BNP)		One day
6-minutes walking distance		One day
NYHA functional class

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients following open heart surgery who need permanent pacing

Exclusion Criteria:

Patients with fast changing need of vasopressors

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kantonsspital Luzern		Lucerne	Canton of Lucerne	6000	Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24464736	Derived	Beeler R, Schoenenberger AW, Bauer P, Kobza R, Bergner M, Mueller X, Schlaepfer R, Zuber M, Erne S, Erne P. Improvement of cardiac function with device-based diaphragmatic stimulation in chronic heart failure patients: the randomized, open-label, crossover Epiphrenic II Pilot Trial. Eur J Heart Fail. 2014 Mar;16(3):342-9. doi: 10.1002/ejhf.20. Epub 2013 Dec 6.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases