Myocardial Minimal Damage After Rapid Ventricular Pacing

NCT02362802 | Completed

• 1 other identifier: GER-EP-015
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Antitachycardia Pacing

Outcome Measures

Primary Outcomes (1)

• High sensitive Troponin

  14-20 hours

Study Arms (2)

Antitachycardia Pacing

ACTIVE COMPARATOR

Implantable cardioverter defibrillator placement with Antitachycardia Pacing. Apart from that usual standard of care.

Device: Implantable Cardioverter Defibrillator

No Antitachycardia Pacing

NO INTERVENTION

Implantable cardioverter defibrillator placement without Antitachycardia Pacing. Apart from that usual standard of care.

Interventions

Implantable Cardioverter Defibrillator DEVICE

Antitachycardia Pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Deutsches Herzzentrum Muenchen: lead

Study Sites (1)

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

Related Publications (1)

• Semmler V, Deutschmann C, Haller B, Lennerz C, Brkic A, Grebmer C, Blazek P, Weigand S, Karch M, Busch S, Kolb C. Myocardial Minimal Damage After Rapid Ventricular Pacing - the prospective randomized multicentre MyDate-Trial. Sci Rep. 2020 Mar 16;10(1):4753. doi: 10.1038/s41598-020-61625-8.

  PMID: 32179792 RESULT

MeSH Terms

Interventions

Defibrillators, Implantable

Intervention Hierarchy (Ancestors)

Defibrillators; Electrodes; Electrical Equipment and Supplies; Equipment and Supplies; Electrodes, Implanted; Prostheses and Implants

Study Officials

• Christof Kolb, MD

  Deutsches Herzzentrum München

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med. C. Kolb

Study Record Dates

• First Submitted: February 1, 2015
• First Posted: February 13, 2015
• Study Start: September 1, 2014
• Primary Completion: May 31, 2017
• Study Completion: January 31, 2018
• Last Updated: March 20, 2023

Record last verified: 2023-03

Locations

DE (1)