Status:
COMPLETED
ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Tachycardia, Ventricular
Ventricular Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 rh...
Detailed Description
Main objective: Compare \& quantify efficacy of two different sequences of burst ATP strategies for the termination of ventricular tachycardia (with Cycle Lenght (CL) of 240ms-320ms) from baseline to ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
925 Patients enrolled
Trial Details
Trial ID
NCT00147277
Start Date
March 1 2004
End Date
January 1 2008
Last Update
July 11 2025
Active Locations (1)
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1
Medtronic Italia SpA
Sesto San Giovanni, MI, Italy, 20099