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Acute Effects of a Non Excitatory Cardial Stimulation

R

RWTH Aachen University

Status

Completed

Conditions

CCM Implantation

Treatments

Other: Blood sample

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

13 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

13 participants in 1 patient group

CCM aggregate
Experimental group
Description:
Taking of 10 blood samples
Treatment:
Other: Blood sample

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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