Myocardial Minimal Damage After Rapid Ventricular Pacing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2018-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Antitachycardia Pacing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antitachycardia Pacing

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

Group Type ACTIVE_COMPARATOR

Implantable Cardioverter Defibrillator

Intervention Type DEVICE

No Antitachycardia Pacing

Implantable cardioverter defibrillator placement without Antitachycardia Pacing.

Apart from that usual standard of care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Implantable Cardioverter Defibrillator

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No