Status:
COMPLETED
ADVANCE CRT - D: Antitachycardia Pacing (ATP) Delivery for Painless Implantable Cardioverter Defibrillator (ICD) Therapy
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Tachycardia, Ventricular
Ventricular Fibrillation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 indicatio...
Detailed Description
Main objective: Compare efficacy of ATP therapy (Burst, 8 pulses, 88 %, 1 sequence) to terminate all types of ventricular tachycardia (all VTs (FVT+VT)) when delivered in the right ventricle (RV) only...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
526 Patients enrolled
Trial Details
Trial ID
NCT00147290
Start Date
February 1 2004
End Date
January 1 2008
Last Update
July 2 2025
Active Locations (1)
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1
Medtronic Italia SpA
Sesto San Giovanni, Milan, Italy, 20099