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

January 12, 2015 updated by: LivaNova

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

462

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Antwepen, Belgium, 2600
        • Algemeen Ziekenhuis - Antwepen
      • Gent, Belgium, 9050
        • Kliniek Maria Middelares - Gent
      • Hasselt, Belgium, 3500. 64
        • Heart Center Virga Jesse Ziekenhuis - Hasselt
      • Montreal, Canada
        • Hopital Sacre Coeur
      • Montreal, Canada, H4Y 1H1
        • CHUM Hôtel-Dieu
      • Aix-en-Provence, France
        • Centre Hospitalier General
      • Bordeaux, France, 33000
        • CHU Le Haut L'Evêque
      • Grenoble, France
        • CHU Hôpital Michallon Grenoble
      • Le Chesnay, France, 78150
        • Clinique de Parly II
      • Le Mans, France
        • Clinique les sources
      • Lomme, France
        • CH St Philibert
      • Lyon, France, 69000
        • Hôpital St Joseph
      • Montpellier, France, 34294
        • Hôpital Arnaud De Villeneuve
      • Nantes, France, 44000
        • CHU Nantes
      • Paris, France, 75016
        • Clinique BIZET
      • Pau, France, 64000
        • CH Pau
      • Rouen, France, 76000
        • CHU Charles Nicolle
      • Toulouse, France, 31000
        • Clinique Pasteur
      • Toulouse, France, 31000
        • Hopital Rangueil
      • Toulouse, France
        • CHU Purpan Toulouse
      • Tours, France
        • CHU Tours
      • Bad Bevensen, Germany
        • Herzkreislaufklinik
      • Bad Nauheim, Germany, 61231
        • Kerckhoff Klinik
      • Berlin, Germany, 13353
        • Charite Campus Virchow
      • Bonn, Germany
        • Universitatskliniken Bonn
      • Coburg, Germany, 96465
        • Klinikum Coburg
      • Garmisch-Partenkirchen, Germany, 82467
        • Klinikum Garmisch-Partenkirchen
      • Hamburg, Germany, 2100
        • Universitätsklinikum Hamburg-Eppendorf
      • Homburg, Germany
        • Universität des Saarlandes
      • Lübeck, Germany, 23501
        • Universitätsklinikum Schleswig-Holstein Campus Lübeck
      • Munchen, Germany
        • Klinikum rechts der Isar
      • Munchen, Germany
        • Klinikum Bogenhausen
      • Munchen, Germany
        • DHZ München
      • Munster, Germany
        • Uniklinik Münster
      • München, Germany, 80337
        • Kardiologische Gemeinschaftspraxis
      • München, Germany, 81000
        • Universitätsklinikum Großhadern
      • Regensburg, Germany, 93047
        • Klinikum der Universität Regensburg
      • Regensburg, Germany, 93047
        • Krankenhaus der Barmherzigen Brüder
      • ULM, Germany
        • Universitätsklinik Ulm
      • Desio, Italy, 20033
        • Ospedale Civile
      • Negrar, Italy
        • Ospedale Sacro Cuore Don Calabria
      • Pavia, Italy, 27100
        • Casa Di Cura Citta Di Pavia
      • San Donato, Italy
        • Policlinico San Donato
      • San Donato Milanese, Italy, 20097
        • Ospedale Clinicizzato San Donato
      • Amsterdam, Netherlands, 1060
        • Onze Lieve Vrouwen Gasthuis
      • Almada, Portugal
        • Hospital Garcia de Orta
      • Guimaraes, Portugal
        • Hospital Senhora da Oliveira
      • London, United Kingdom
        • St Peters Hospital
      • Taunton, United Kingdom, TA1 4DY
        • Musgrove Park Hospltal
      • Worthing, United Kingdom, NR20 4LB
        • Worthing And Southlands Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Piedmont Hospital Research Institute
      • Decatur, Georgia, United States, 30301
        • Atlanta VA Medical Center
    • Louisiana
      • Mandeville, Louisiana, United States, 70471
        • Southern Medical Research, LLC
    • Ohio
      • Jeffersonville, Ohio, United States, 43128
        • River City Cardiology
    • South Carolina
      • Florence, South Carolina, United States, 29501
        • Pee Dee Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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).
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
Single-chamber device therapy with settings which are common in clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
implant, 3 months, 9 months, 15 months, 21 months and 27 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Kolb, Deutsches Herzzentrum Munchen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Primary Completion (ACTUAL)

December 1, 2011

Study Completion (ACTUAL)

October 1, 2013

Study Registration Dates

First Submitted

August 4, 2008

First Submitted That Met QC Criteria

August 6, 2008

First Posted (ESTIMATE)

August 7, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

January 13, 2015

Last Update Submitted That Met QC Criteria

January 12, 2015

Last Verified

January 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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