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Myocardial Minimal Damage After Rapid Ventricular Pacing (MyDate)

G

German Heart Center Munich

Status

Completed

Conditions

Antitachycardia Pacing

Treatments

Device: Implantable Cardioverter Defibrillator

Study type

Interventional

Funder types

Other

Identifiers

NCT02362802
GER-EP-015

Details and patient eligibility

About

This study aims to investigate the impact of antitachycardia pacing ( ATP) on the myocardial tissue with respect to its potential micro damage measured by several myocardial markers, especially by high-sensitive TroponinT.

Enrollment

149 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • All patients for de-novo implantation of a transvenous ICD (single chamber, dual chamber or cardiac resynchronization tehrapy) with left pectoral device position and planned apical location of the right ventricular defibrillation electrode.

Exclusion criteria

  • Resuscitation, cardiac surgical procedure, acute coronary syndrome, acute myocardial infarction, coronary revascularisation, cardioversion or ablation during the past 4 weeks, if baseline high-sensitive Troponin T is elevated
  • Known stenosis of coronary vessels with indication for coronary intervention or operative revascularisation
  • Intracardiac thrombus or general contraindication against ventricular burst stimulation or intraoperative ICD-testing
  • Atypical lead implantation with indication for defibrillation threshold testing by induction of ventricular fibrillation
  • Right sided implantation of ICD
  • Planned electrical cardioversion
  • Lead explantation or -extraction during procedure
  • Redo procedure (except of additional implantation of a right ventricular ICD lead)
  • Present temporary pacemaker electrode
  • ASA >= IV or NYHA IV
  • Cardiogenic shock
  • Pulmonary embolism, cerebrovascular insult or dialysis in the past 4 weeks
  • Lack of consent of patient
  • Minority of patient

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

149 participants in 2 patient groups

Antitachycardia Pacing
Active Comparator group
Description:
Implantable cardioverter defibrillator placement with Antitachycardia Pacing. Apart from that usual standard of care.
Treatment:
Device: Implantable Cardioverter Defibrillator
No Antitachycardia Pacing
No Intervention group
Description:
Implantable cardioverter defibrillator placement without Antitachycardia Pacing. Apart from that usual standard of care.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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