Optimal Anti-tachycardia Therapy in Implantable Cardioverter-defibrillator (ICD) Patients Without Pacing Indications (OPTION)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Optimal Antitachycardia Therapy in ICD Patients Without Pacing Indications|
- The first part is the time to first occurrence of inappropriate ICD shock therapy. The second part is the composite endpoint of time to first occurrence of death (all causes)or Hospitalizations due to cardio-vascular event. [ Time Frame: implant, 3 months, 9 months, 15 months, 21 months and 27 months ] [ Designated as safety issue: No ]
- all cause mortality and cardio-vascular related mortality [ Time Frame: 27 months follow up ] [ Designated as safety issue: Yes ]
- Hospitalizations due to cardio-vascular event (specified for each type of event) [ Time Frame: 27 months follow up ] [ Designated as safety issue: Yes ]
- Time to first occurrence of inappropriate ICD shock therapy [ Time Frame: 27 months follow up ] [ Designated as safety issue: No ]
- Evaluation of the impact of the different therapies on quality of life and heart failure status [ Time Frame: 27 months follow up ] [ Designated as safety issue: No ]
- Sensitivity and specificity for VT/SVT discrimination for the first 100 patients in each group. [ Time Frame: 27 months ] [ Designated as safety issue: No ]
- Inappropriate overall device reactions defined by inappropriate shock and/or ATP therapy or inappropriate therapy delay/inhibition > 2 minutes on VTs [ Time Frame: 27 months ] [ Designated as safety issue: No ]
- time to first documented AF occurrence and number of patients moving into permanent or persistent AF [ Time Frame: 27 months follow up ] [ Designated as safety issue: No ]
- Cardiac dimensions obtained by echo evaluation for a subset of patients of both groups [ Time Frame: Baseline and 27 months ] [ Designated as safety issue: No ]
- Slow VT incidence [ Time Frame: 27 months ] [ Designated as safety issue: No ]
- Unscheduled visits and hospitalizations due to slow VT [ Time Frame: 27 months follow up ] [ Designated as safety issue: No ]
- System related complications including lead dislodgements, exit block, oversensing which requires programming corrections, infections, complications which require reintervention [ Time Frame: 27 months follow up ] [ Designated as safety issue: Yes ]
- Cumulative percentage of ventricular pacing and proportion of patients with 0% V pacing. [ Time Frame: 27 months follow up ] [ Designated as safety issue: No ]
- Overall success rate of ATP in the FVT zone [ Time Frame: 27 months ] [ Designated as safety issue: Yes ]
- Cost effectiveness of applied ICD therapy [ Time Frame: 27 months ] [ Designated as safety issue: No ]
- PPV and NPV for Tvar risk stratification [ Time Frame: 27 months ] [ Designated as safety issue: No ]
|Study Start Date:||June 2006|
|Study Completion Date:||October 2013|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Dual-chamber detection and activated treatment (at least ATP) in the slow VT-zone plus activated AAIsafeR pacing (basic rate 60 bpm).
Device: Ovatio DR 6550
Dual-chamber ICD therapy with minimized ventricular pacing
Single-chamber ICD following clinical practice but with a monitoring zone active to allow the documentation of all occurring ventricular arrhythmias
Device: OVATIO DR 6550
Single-chamber device therapy with settings which are common in clinical practice.
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.
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|Principal Investigator:||Kolb||Deutsches Herzzentrum München|