Phase 4
Completed N=925
ADVANCE-D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
Tachycardia, Ventricular · ventricular fibrillation
Source: ClinicalTrials.gov NCT00147277 ↗
Enrolled (actual)
925
Serious AEs
—
Results posted
May 2009
Primary outcomePrimary: Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec) — 64.9; 69.7 Percentage of FVT episodes terminated
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec) |
64.9; 69.7 | — |
| SECONDARY Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention |
— | — |
| SECONDARY Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms |
— | — |
| SECONDARY Percent Reduction in Shocks Delivered Per Patient for Treating FVT |
— | — |
| SECONDARY Compare Likelihood of Syncopal Events Associated With FVT |
— | — |
| SECONDARY Evaluate Different Possible Predictors of ATP Success |
— | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00147277). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.