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OpenTrials
Completed

NCT Number: NCT02362802

Myocardial Minimal Damage After Rapid Ventricular Pacing

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.

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Key information

Conditions

Antitachycardia Pacing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Implantable Cardioverter Defibrillator

Device

Primary outcomes

  1. High sensitive Troponin

    Time frame: 14-20 hours

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Registry information

Acronym: MyDate

Important dates

Study start
2014
Primary completion
2017
Study completion
2018
First posted
Feb 13, 2015
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.