Phase 4
Completed N=526
ADVANCE CRT - D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
Tachycardia, Ventricular · ventricular fibrillation
Source: ClinicalTrials.gov NCT00147290 ↗
Enrolled (actual)
526
Serious AEs
—
Results posted
Jun 2009
Primary outcomePrimary: Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia. — 64.7; 68.2 Percent of VT episodes terminated
Summary
To compare the efficacy of RV and BiV ATP for the termination of ventricular arrhythmias in patients who are candidates to a cardiac resynchronisation therapy (CRT) and have a Class I or IIA indication for ICD implantation.
The hypothesis of delivering ATP from different sites (RV or BIV) has never been evaluated in a prospective, controlled and randomized study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Anti Tachycardia Pacing (ATP) Therapy (Burst, 8 Pulses, 88 %, 1 Sequence) to Terminate All Types of Ventricular Tachycardia. |
64.7; 68.2 | — |
| SECONDARY Compare Efficacy of the First BiV and RV ATP to Terminate FVT |
— | — |
| SECONDARY Compare Efficacy of the First BiV and RV ATP to Terminate Slow VT |
— | — |
| SECONDARY Compare Efficacy of BiV and RV ATP (All ATP Therapies) to Terminate Slow VT |
— | — |
| SECONDARY Determine the Rate of Both FVT and VT Episodes Which Are Accelerated or Degenerates Into VF |
— | — |
Eligibility Criteria
Inclusion Criteria
- CRT + ICD indications (Class I-IIA) according to the guidelines
- Patients have been implanted with a Medtronic Marquis Family ICD capable of RV-ATP or BIV-ATP
- Patients in chronic AF who undergo a complete AV ablation and that the complete AV block is confirmed at PHD
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
- Replacements and upgrades
- Epicardial lead
- Mechanical tricuspid valve
- Ventricular Tachyarrhythmias associated with reversible causes
- 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
Data sourced from ClinicalTrials.gov (NCT00147290). 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.