Optimal Anti-tachycardia Therapy in Implantable Cardioverter-defibrillator (ICD) Patients Without Pacing Indications (OPTION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00729703
Recruitment Status : Completed
First Posted : August 7, 2008
Last Update Posted : January 13, 2015
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tachycardia Device: Ovatio DR 6550 Device: OVATIO DR 6550 Phase 4

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 462 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Optimal Antitachycardia Therapy in ICD Patients Without Pacing Indications
Study Start Date : June 2006
Actual Primary Completion Date : December 2011
Actual Study Completion Date : October 2013

Arm Intervention/treatment
Experimental: 1
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
Experimental: 2
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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. all cause mortality and cardio-vascular related mortality [ Time Frame: 27 months follow up ]
  2. Hospitalizations due to cardio-vascular event (specified for each type of event) [ Time Frame: 27 months follow up ]
  3. Time to first occurrence of inappropriate ICD shock therapy [ Time Frame: 27 months follow up ]
  4. Evaluation of the impact of the different therapies on quality of life and heart failure status [ Time Frame: 27 months follow up ]
  5. Sensitivity and specificity for VT/SVT discrimination for the first 100 patients in each group. [ Time Frame: 27 months ]
  6. 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 ]
  7. time to first documented AF occurrence and number of patients moving into permanent or persistent AF [ Time Frame: 27 months follow up ]
  8. Cardiac dimensions obtained by echo evaluation for a subset of patients of both groups [ Time Frame: Baseline and 27 months ]
  9. Slow VT incidence [ Time Frame: 27 months ]
  10. Unscheduled visits and hospitalizations due to slow VT [ Time Frame: 27 months follow up ]
  11. System related complications including lead dislodgements, exit block, oversensing which requires programming corrections, infections, complications which require reintervention [ Time Frame: 27 months follow up ]
  12. Cumulative percentage of ventricular pacing and proportion of patients with 0% V pacing. [ Time Frame: 27 months follow up ]
  13. Overall success rate of ATP in the FVT zone [ Time Frame: 27 months ]
  14. Cost effectiveness of applied ICD therapy [ Time Frame: 27 months ]
  15. PPV and NPV for Tvar risk stratification [ Time Frame: 27 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient has been prescribed the implantation for an ICD system accordingly to the relevant currently-approved ACC/AHA guidelines 1 or ESC guidelines 35 or any relevant currently-approved local guidelines for the implantation of an ICD-system
  • Impaired left ventricular function demonstrated by a left-ventricular ejection fraction (LVEF) ≤ 40 %, measured by angio-scintigraphy, echocardiography, or contrast ventriculogram.
  • An optimal (as determined by the enrolling physician) medical regimen.
  • Patient has received all relevant information on the study, and has signed and dated a consent form.

Exclusion Criteria:

  • Any generally accepted indication for standard cardiac pacing, or any contraindication for standard cardiac pacing.
  • Any indication for CRT accordingly to the relevant currently-approved ACC/AHA1 or ESC35 guidelines for the implantation of a CRT system.
  • Any contraindication for ICD therapy and the implant of a dual chamber ICD.
  • ICD replacement
  • Chronic atrial arrhythmias or cardioversion for atrial fibrillation within the past month.
  • A PR interval > 250 ms or AR interval > 300 ms measured at implant.
  • Hypertrophic obstructive cardiomyopathy.
  • Acute myocarditis.
  • Unstable coronary symptoms or myocardial infarction within the last month.
  • Recent (within the last month) or planned cardiac revascularization or coronary angioplasty.
  • Recently performed (in the last month) or planned cardiac surgery
  • Already included in another clinical study.
  • Life expectancy less than 24 months.
  • Inability to understand the purpose of the study or refusal to cooperate.
  • Inability or refusal to provide informed consent and, if not part of the informed consent, a Health Insurance Portability and Accountability Act (HIPAA) authorization.
  • Unavailability for scheduled follow-up at the implanting or cooperating center.
  • Age of less than 18 years.
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00729703

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Sponsors and Collaborators
Principal Investigator: Kolb Deutsches Herzzentrum München