Ventricular Fibrillation Clinical Trial
— ADVANCE_DOfficial title:
ADVANCE-D: ATP Delivery for Painless ICD Therapy
Verified date | August 2015 |
Source | Medtronic Bakken Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 925 |
Est. completion date | January 2008 |
Est. primary completion date | January 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Medtronic Italia SpA | Sesto San Giovanni | MI |
Lead Sponsor | Collaborator |
---|---|
Medtronic Bakken Research Center |
Italy,
Lunati M, Defaye P, Mermi J, Garcia-Alberola A, Merino JL, Arenal A, Cappato R, Navarro X, Passardi M, Santini M. Improvement of quality of life by means of antitachy pacing: from PainFREE to the ADVANCE-D Trial. Pacing Clin Electrophysiol. 2006 Dec;29 Suppl 2:S35-9. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy of Anti Tachycardia Pacing (ATP) Therapy to Terminate Fast Ventricular Tachycardia (With Cycle Length of 240ms-320msec) | Termination of Ventricular Tachycardia is calculated as percentage of successfully terminated episodes, adjusted for multiple events with (GEE) method. This technique yields an average therapy efficacy and 95% CI that is based on number of patients, number of episodes per patient, and magnitude of the correlation between responses within patients. | one year | No |
Secondary | Efficacy of ATP in Successfully Treating FVT for Patients in Primary and Secondary Prevention | one year | No | |
Secondary | Acceleration Rate or Degenerated Into VF of ATP for Treating FVT in the 2 Arms | one year | No | |
Secondary | Percent Reduction in Shocks Delivered Per Patient for Treating FVT | one year | No | |
Secondary | Compare Likelihood of Syncopal Events Associated With FVT | one year | No | |
Secondary | Evaluate Different Possible Predictors of ATP Success | one year | No |
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