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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sorin Group
ClinicalTrials.gov Identifier:
NCT00729703
First received: August 4, 2008
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Tachycardia
Device: Ovatio DR 6550
Device: OVATIO DR 6550
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Sorin Group:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 461
Study Start Date: June 2006
Study Completion Date: October 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729703

  Show 55 Study Locations
Sponsors and Collaborators
Sorin Group
Investigators
Principal Investigator: Kolb Deutsches Herzzentrum München
  More Information

No publications provided by Sorin Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sorin Group
ClinicalTrials.gov Identifier: NCT00729703     History of Changes
Other Study ID Numbers: OPTION - ITAC03
Study First Received: August 4, 2008
Last Updated: October 14, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Italy: Ethics Committee
Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Sorin Group:
ICD
Minimized
ventricular
pacing
indication
Clinical outcome
Inappropriate shock

Additional relevant MeSH terms:
Tachycardia
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014