Acute Effects of a Non Excitatory Cardial Stimulation

NCT ID: NCT01789112

Last Updated: 2018-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2017-06-30

Brief Summary

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Electric stimulation by cardial contractility modulation (CCM)to improve contractility and physical capacity

Detailed Description

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Conditions

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CCM Implantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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CCM aggregate

Taking of 10 blood samples

Group Type EXPERIMENTAL

Blood sample

Intervention Type OTHER

Taking of blood sample

Interventions

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Blood sample

Taking of blood sample

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RWTH Aachen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sebastian Reith, MD

Role: PRINCIPAL_INVESTIGATOR

RWTH Aachen, Medical Departement I Univerity Hospital Aachen

Locations

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Univeristy Hospital Aachen

Aachen, North Rhine Westfalia, Germany

Site Status

Countries

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Germany

Other Identifiers

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12-032

Identifier Type: -

Identifier Source: org_study_id

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