Acute Effects of a Non Excitatory Cardial Stimulation | NCT01789112

Studies
Acute Effects of a Non Excitatory Cardial Stimulation

NCT01789112

Sponsor

RWTH Aachen University

Status

Completed

Last Update Posted

Jul 6, 2018Actual

Enrollment

13Actual

Phase

Not Applicable

Conditions

CCM Implantation

Interventions

Blood sample

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

Jul 2018

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

Jul 2012Actual

Primary Completion Date

Jun 30, 2017Actual

Completion Date

Jun 30, 2017Actual

First Submitted Date

Feb 8, 2013

First Submission Date that Met QC Criteria

Feb 8, 2013

First Posted Date

Feb 11, 2013Estimated

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 3, 2018

Last Update Posted Date

Jul 6, 2018Actual

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

13Actual

Label	Type	Description	Intervention Names
CCM aggregate	Experimental	Taking of 10 blood samples	Other: Blood sample

Name	Type	Description	Arm Group Labels	Other Names
Blood sample	Other	Taking of blood sample	CCM aggregate

Measure	Description	Time Frame
positive inotropic effects by CCM stimulation		15 minutes

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

planned CCM Implantation
systolic left ventricular dysfunction despite of adequate therapy of heart failure (NYHA II, III, IV)
implanted pacemaker, defibrillator or pacemaker during CS intubation
written informed consent
open entryways

Exclusion Criteria:

anemia Hemoglobin (HB)<8 mg/dl
lying coronary sinus (CS) tube or CS being not able to intubate
chronic atrial fibrillation or flutter
mechanic tricuspid valve prothesis
no access via subclavian vein
patients with VVI pacemaker being stimulated 110%
idiopathic hypertrophic cardiomyopathy, restrictive constrictive cardiomyopathy or heart failure because of known inflammatory or infiltrative illnesses or constrictive illness
acute myocardial ischemia presented by angina pectoris or ECG changes under load
patients being hospitalized because of heart failure during the last month and have to be treated with intravenous diuretics or inotropic substances
acute coronary syndrome should not be implanted for at least 3 month
patients with mechanic aortic or tricuspid valve
patients after heart transplantation
patients with clinical significant ectopy, defined by > 8.900 PVCs during 24 hours at beginning Holter monitoring
patients after hypertensive crisis
patients with acute renal failure
Ejection Fraction (EF) > 35
patients after left ventricular pacemaker electrode
pregnant or breast feeding women
patients with heart failure after sepsis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis