Tachycardia Clinical Trial
Official title:
Optimal Antitachycardia Therapy in ICD Patients Without Pacing Indications
This study evaluates the impact of a new pacing mode avoiding unnecessary ventricular stimulation in combination with advanced dual chamber detection with slow VT management on the clinical outcome for hospitalization and mortality and inadequate therapy in medically stable, ICD-indicated patients with impaired left ventricular function (LVEF ≤ 40%) who do not have pacing indications and no indication for Cardiac Resynchronization Therapy (CRT). It compares a new pacing mode avoiding ventricular stimulation when not needed combined with dual chamber detection with a pure ventricular back up pacing and single chamber detection criteria with pure ventricular back up pacing. Therapies are compared in a prospective, randomized, single-blinded, parallel trial with a 24-month randomized treatment period. Randomization follows a 1:1 ratio. ICD therapy is enabled for all patients throughout the study. All patients receive optimal drug therapy for arrhythmia and heart failure treatment.
All patients will receive an implantable cardioverter defibrillator OVATIO™ DR model 6550 or
a later Sorin Group device offering the same functions. After Enrolment visit but before
implant, patients will be randomized in two arms according to the parallel study design.
Whenever possible before implant there will be the first Holter recording for the Tvar risk
stratification procedure. In case Tvar recording could not be performed before implant it
has to be performed before patient leaves the hospital post implant in unpaced rhythm.
The dual-chamber arm will be programmed to 3 detection zones with PARAD+ activated.
The TDI for the slow VT zone will be set to 500 ms (120 bpm - or in case the resting rate is
higher than 90 bpm it is recommended to adjust this parameter to: resting rate + 30 bpm) and
at least one ATP program activated as specified in table 1.
A VT zone with a TDI of 353 ms (170 bpm) in case of no history of VT or a TDI cycle length
equalling slowest documented VT interval (spontaneous or induced) plus 50 ms is required. In
this 2nd VT zone therapies need to be activated in this group.
AAIsafeR2 mode will be activated with a basic rate of 60 bpm. The single-chamber arm will be
programmed to optimal detection with Acceleration (Onset), Stability and Long Cycle Search
(VTLC) activated. A VT zone is requested in this group, with the same programming procedures
as described above. Therapies will be set according to the clinical judgment of the
participating investigators but a Slow VT-zone with TDI 500 ms in monitoring setting at
least is required.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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