Myocardial Minimal Damage After Rapid Ventricular Pacing (MyDate)

March 17, 2023 updated by: Adnan Kastrati, MD, Deutsches Herzzentrum Muenchen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany, 80636
        • Deutsches Herzzentrum Muenchen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Antitachycardia Pacing
Implantable cardioverter defibrillator placement with Antitachycardia Pacing. Apart from that usual standard of care.
Device: Implantable Cardioverter Defibrillator
No Intervention: No Antitachycardia Pacing

Implantable cardioverter defibrillator placement without Antitachycardia Pacing.

Apart from that usual standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
High sensitive Troponin
Time Frame: 14-20 hours
14-20 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

May 31, 2017

Study Completion (Actual)

January 31, 2018

Study Registration Dates

First Submitted

February 1, 2015

First Submitted That Met QC Criteria

February 12, 2015

First Posted (Estimate)

February 13, 2015

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • GER-EP-015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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