ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
NCT00147277 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 925
Last updated 2025-07-11
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 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.
Conditions
- Tachycardia, Ventricular
- Ventricular Fibrillation
Interventions
- DEVICE
-
Implantable Cardiac Defibrillator
Medtronic Marquis Family ICD, capable of Anti Tachy Pacing (ATP) for Fast Ventricular Tachycardia (FVT) via Ventricular Fibrillation (VF) zone
Sponsors & Collaborators
-
Medtronic Cardiac Rhythm and Heart Failure
lead INDUSTRY
Principal Investigators
-
Maurizio Lunati, Dr. · Ospedale Niguarda Cà Granda - Milano
-
Riccardo Cappato, Dr. · Istituto Policlinico S. Donato Milanese
-
Massimo Santini, Prof. · San Filippo Neri - Roma
-
Angel Arenal, Dr. · Hospital Gregorio Marañón, Madrid
-
Josè Luis Merino, Dr. · Hospital Universitario La Paz
-
Arcadio Garcia-Alberola, Dr. · Hospital Universitario Virgen de la Arrixaca
-
Johann Mermi, Dr. · Clinic Center Dortmund
-
Pascal Defaye, Dr. · University Hospital, Grenoble
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-03-31
- Primary Completion
- 2006-01-31
- Completion
- 2008-01-31
Countries
- Italy
Study Locations
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