Myocardial Minimal Damage After Rapid Ventricular Pacing

Not Applicable

Completed

• Conditions: Antitachycardia Pacing
• Interventions: Device: Implantable Cardioverter Defibrillator

• Registration Number: NCT02362802
• Lead Sponsor: Deutsches Herzzentrum Muenchen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-02-01
• Study First Submitted QC: 2015-02-12
• Study First Posted: 2015-02-13
• Primary Completion: 2017-05-31
• Study Completion: 2018-01-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-17
• Last Update Posted: 2023-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antitachycardia Pacing	Implantable Cardioverter Defibrillator	Implantable cardioverter defibrillator placement with Antitachycardia Pacing. Apart from that usual standard of care.

Primary Outcome Measures

Name	Time	Method
High sensitive Troponin	14-20 hours

Trial Locations

Locations (1)

Deutsches Herzzentrum Muenchen; 🇩🇪 Munich, Germany