ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy

Sponsored by Medtronic Cardiac Rhythm and Heart Failure

About this trial

Last updated a year ago

Study ID

900AD

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

Accepting

18+ Years

All Sexes

Trial Timing

Ended 18 years ago

What is this trial about?

The purpose of this study is to estimate and quantify the difference in efficacy of two sequences of ATP therapies (burst 15 pulses, 88% versus burst 8 pulses, 88%) during an episode of spontaneous rhythms classified as fast ventricular tachycardia (FVT) via ventricular fibrillation (VF) in patients who have a Class I or II A indication for ICD implantation, and thus to promote the "painless" therapy aspect of ICD treatment and improve quality of life outcomes for patients.

What are the participation requirements?

Inclusion Criteria

* ICD indications (Class I-II A) according to the guidelines (patient with coronary artery disease [CAD] or non-CAD in primary or secondary ICD prevention)

* Patients have been implanted with a Medtronic Marquis family ICD capable of ATP for FVT via VF

Exclusion Criteria

* Patient's life expectancy less than 1 year due to a non-cardiac chronic disease

* Patient on heart transplant list which is expected in < 1 year

* Patient's age less than 18 years

* ICD replacements and upgrading (single chamber [SC] ICD® dual chamber [DC] ICD)

* Unwillingness or inability to provide written informed consent

* Enrollment in, or intention to participate in, another clinical study during the course of this study

* Inaccessibility for follow-up at the study center

* Ventricular tachyarrhythmias associated with reversible causes

* Brugada syndrome, long QT and hypertrophic cardiomyopathy (HCM) patients

* Other electrical implantable devices (neurostimulators, etc.)

* Mechanical tricuspid valve