Phase 4
N=1,902
Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III
Heart Disease
Bottom Line
View on ClinicalTrials.gov: NCT00617175 ↗Enrolled (actual)
1,902
Serious AEs
29.3%
Results posted
Feb 2013
Primary outcome: Primary: For the Primary Endpoint the Reduction of Ventricular Therapies (ATP and Shocks) Delivered for Treating Fast Spontaneous Arrhythmia Episodes Was Measured. — 67.1; 41.9 rate of therapies per 100 patient-years — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Implantable Defibrillator (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY For the Primary Endpoint the Reduction of Ventricular Therapies (ATP and Shocks) Delivered for Treating Fast Spontaneous Arrhythmia Episodes Was Measured. |
67.1; 41.9 | <0.001 sig |
| SECONDARY Evaluate the Percent Reduction in the Number of Shocks Delivered Per Subject for Treating Spontaneous Episodes With a Fast Cycle Length (CL < 320 ms) and for Spontaneous Ventricular Episodes. |
— | — |
Summary
To demonstrate a reduction in the number of ventricular therapies (ATP and Shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (CL≤ 320ms) as a consequence of self-termination and better arrhythmia discrimination due to a greater number of R-R intervals necessary to detect ventricular events.
Eligibility Criteria
Inclusion Criteria
- Either ICD or CRT+ICD indications (Class I-IIA) according to the current AHA / ACC / ESC guidelines.
- Previous implant of a Medtronic device including "ATP During Charging" feature for 15 days at the maximum.
Exclusion Criteria
- ICD replacements and upgrading.
- Brugada Syndrome, Long QT and HCM patients
- Ventricular tachyarrhythmia associated with reversible cause.
- Other electrical implantable devices (Neurostimulators, etc.).
- Subject's life expectancy less than 1 year.
- Subject on heart transplant list which is expected in less than 1 year.
- Subject is <18 years of age, or the subject is under a minimum age that is required as defined by local law
- Women who are pregnant or women of childbearing potential who are not on a reliable form of birth control.
- Unwillingness or inability to provide written informed consent.
- Enrolment in, or intention to participate in, another clinical trial.
- Inaccessibility to come to the study center for the follow-up visits.
- Mechanical tricuspid valve.
Data sourced from ClinicalTrials.gov (NCT00617175). 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.