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

Primary Purpose

Tachycardia

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ovatio DR 6550
OVATIO DR 6550
Sponsored by
LivaNova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tachycardia focused on measuring ICD, Minimized, ventricular, pacing, indication, Clinical outcome, Inappropriate shock

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Piedmont Hospital Research Institute
  • Atlanta Va Medical Center
  • Southern Medical Research, Llc
  • River City Cardiology
  • Pee Dee Cardiology
  • Algemeen Ziekenhuis - Antwepen
  • Kliniek Maria Middelares - Gent
  • Heart Center Virga Jesse Ziekenhuis - Hasselt
  • CHUM Hotel-Dieu
  • Hôpital Sacré Coeur
  • Centre Hospitalier General
  • CHU Le Haut L'Evêque
  • CHU Hôpital Michallon Grenoble
  • Clinique De Parly II
  • Clinique les sources
  • CH ST Philibert
  • Hôpital St Joseph
  • Hopital Arnaud De Villeneuve
  • CHU Nantes
  • Clinique Bizet
  • CH Pau
  • CHU Charles Nicolle
  • Clinique Pasteur
  • Hôpital Rangueil
  • CHU Purpan Toulouse
  • CHU Tours
  • Herzkreislaufklinik
  • Kerckhoff Klinik
  • Charite Campus Virchow
  • Universitätskliniken Bonn
  • Klinikum Coburg
  • Klinikum Garmisch-Partenkirchen
  • Universitätsklinikum Hamburg-Eppendorf
  • Universität des Saarlandes
  • Universitatsklinikum Schleswig-Holstein Campus Lübeck
  • DHZ Munchen
  • Klinikum Bogenhausen
  • Klinikum rechts der Isar
  • Uniklinik Munster
  • Kardiologische Gemeinschaftspraxis
  • Universitatsklinikum Grosshadern
  • Klinikum der Universität Regensburg
  • Krankenhaus der Barmherzigen Brüder
  • Universitätsklinik Ulm
  • Ospedale Civile
  • Ospedale Sacro Cuore Don Calabria
  • Casa Di Cura Citta Di Pavia
  • Ospedale Clinicizzato San Donato
  • Policlinico San Donato
  • Onze Lieve Vrouwen Gasthuis
  • Hospital Garcia de Orta
  • Hospital Senhora da Oliveira
  • St Peters Hospital
  • Musgrove Park Hospltal
  • Worthing And Southlands Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Dual-chamber detection and activated treatment (at least ATP) in the slow VT-zone plus activated AAIsafeR pacing (basic rate 60 bpm).

Single-chamber ICD following clinical practice but with a monitoring zone active to allow the documentation of all occurring ventricular arrhythmias

Outcomes

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.

Secondary Outcome Measures

all cause mortality and cardio-vascular related mortality
Hospitalizations due to cardio-vascular event (specified for each type of event)
Time to first occurrence of inappropriate ICD shock therapy
Evaluation of the impact of the different therapies on quality of life and heart failure status
Sensitivity and specificity for VT/SVT discrimination for the first 100 patients in each group.
Inappropriate overall device reactions defined by inappropriate shock and/or ATP therapy or inappropriate therapy delay/inhibition > 2 minutes on VTs
time to first documented AF occurrence and number of patients moving into permanent or persistent AF
Cardiac dimensions obtained by echo evaluation for a subset of patients of both groups
Slow VT incidence
Unscheduled visits and hospitalizations due to slow VT
System related complications including lead dislodgements, exit block, oversensing which requires programming corrections, infections, complications which require reintervention
Cumulative percentage of ventricular pacing and proportion of patients with 0% V pacing.
Overall success rate of ATP in the FVT zone
Cost effectiveness of applied ICD therapy
PPV and NPV for Tvar risk stratification

Full Information

First Posted
August 4, 2008
Last Updated
January 12, 2015
Sponsor
LivaNova
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1. Study Identification

Unique Protocol Identification Number
NCT00729703
Brief Title
Optimal Anti-tachycardia Therapy in Implantable Cardioverter-defibrillator (ICD) Patients Without Pacing Indications
Acronym
OPTION
Official Title
Optimal Antitachycardia Therapy in ICD Patients Without Pacing Indications
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
LivaNova

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tachycardia
Keywords
ICD, Minimized, ventricular, pacing, indication, Clinical outcome, Inappropriate shock

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
462 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Dual-chamber detection and activated treatment (at least ATP) in the slow VT-zone plus activated AAIsafeR pacing (basic rate 60 bpm).
Arm Title
2
Arm Type
Experimental
Arm Description
Single-chamber ICD following clinical practice but with a monitoring zone active to allow the documentation of all occurring ventricular arrhythmias
Intervention Type
Device
Intervention Name(s)
Ovatio DR 6550
Intervention Description
Dual-chamber ICD therapy with minimized ventricular pacing
Intervention Type
Device
Intervention Name(s)
OVATIO DR 6550
Intervention Description
Single-chamber device therapy with settings which are common in clinical practice.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
all cause mortality and cardio-vascular related mortality
Time Frame
27 months follow up
Title
Hospitalizations due to cardio-vascular event (specified for each type of event)
Time Frame
27 months follow up
Title
Time to first occurrence of inappropriate ICD shock therapy
Time Frame
27 months follow up
Title
Evaluation of the impact of the different therapies on quality of life and heart failure status
Time Frame
27 months follow up
Title
Sensitivity and specificity for VT/SVT discrimination for the first 100 patients in each group.
Time Frame
27 months
Title
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
Title
time to first documented AF occurrence and number of patients moving into permanent or persistent AF
Time Frame
27 months follow up
Title
Cardiac dimensions obtained by echo evaluation for a subset of patients of both groups
Time Frame
Baseline and 27 months
Title
Slow VT incidence
Time Frame
27 months
Title
Unscheduled visits and hospitalizations due to slow VT
Time Frame
27 months follow up
Title
System related complications including lead dislodgements, exit block, oversensing which requires programming corrections, infections, complications which require reintervention
Time Frame
27 months follow up
Title
Cumulative percentage of ventricular pacing and proportion of patients with 0% V pacing.
Time Frame
27 months follow up
Title
Overall success rate of ATP in the FVT zone
Time Frame
27 months
Title
Cost effectiveness of applied ICD therapy
Time Frame
27 months
Title
PPV and NPV for Tvar risk stratification
Time Frame
27 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kolb
Organizational Affiliation
Deutsches Herzzentrum München
Official's Role
Principal Investigator
Facility Information:
Facility Name
Piedmont Hospital Research Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Atlanta Va Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30301
Country
United States
Facility Name
Southern Medical Research, Llc
City
Mandeville
State/Province
Louisiana
ZIP/Postal Code
70471
Country
United States
Facility Name
River City Cardiology
City
Jeffersonville
State/Province
Ohio
ZIP/Postal Code
43128
Country
United States
Facility Name
Pee Dee Cardiology
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
Facility Name
Algemeen Ziekenhuis - Antwepen
City
Antwepen
ZIP/Postal Code
2600
Country
Belgium
Facility Name
Kliniek Maria Middelares - Gent
City
Gent
ZIP/Postal Code
9050
Country
Belgium
Facility Name
Heart Center Virga Jesse Ziekenhuis - Hasselt
City
Hasselt
ZIP/Postal Code
3500. 64
Country
Belgium
Facility Name
CHUM Hotel-Dieu
City
Montreal
ZIP/Postal Code
H4Y 1H1
Country
Canada
Facility Name
Hôpital Sacré Coeur
City
Montreal
Country
Canada
Facility Name
Centre Hospitalier General
City
Aix-en-Provence
Country
France
Facility Name
CHU Le Haut L'Evêque
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
CHU Hôpital Michallon Grenoble
City
Grenoble
Country
France
Facility Name
Clinique De Parly II
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Facility Name
Clinique les sources
City
Le Mans
Country
France
Facility Name
CH ST Philibert
City
Lomme
Country
France
Facility Name
Hôpital St Joseph
City
Lyon
ZIP/Postal Code
69000
Country
France
Facility Name
Hopital Arnaud De Villeneuve
City
Montpellier
ZIP/Postal Code
34294
Country
France
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
Clinique Bizet
City
Paris
ZIP/Postal Code
75016
Country
France
Facility Name
CH Pau
City
Pau
ZIP/Postal Code
64000
Country
France
Facility Name
CHU Charles Nicolle
City
Rouen
ZIP/Postal Code
76000
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
Hôpital Rangueil
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
CHU Purpan Toulouse
City
Toulouse
Country
France
Facility Name
CHU Tours
City
Tours
Country
France
Facility Name
Herzkreislaufklinik
City
Bad Bevensen
Country
Germany
Facility Name
Kerckhoff Klinik
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Charite Campus Virchow
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Universitätskliniken Bonn
City
Bonn
Country
Germany
Facility Name
Klinikum Coburg
City
Coburg
ZIP/Postal Code
96465
Country
Germany
Facility Name
Klinikum Garmisch-Partenkirchen
City
Garmisch-Partenkirchen
ZIP/Postal Code
82467
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
2100
Country
Germany
Facility Name
Universität des Saarlandes
City
Homburg
Country
Germany
Facility Name
Universitatsklinikum Schleswig-Holstein Campus Lübeck
City
Lübeck
ZIP/Postal Code
23501
Country
Germany
Facility Name
DHZ Munchen
City
Munchen
Country
Germany
Facility Name
Klinikum Bogenhausen
City
Munchen
Country
Germany
Facility Name
Klinikum rechts der Isar
City
Munchen
Country
Germany
Facility Name
Uniklinik Munster
City
Munster
Country
Germany
Facility Name
Kardiologische Gemeinschaftspraxis
City
München
ZIP/Postal Code
80337
Country
Germany
Facility Name
Universitatsklinikum Grosshadern
City
München
ZIP/Postal Code
81000
Country
Germany
Facility Name
Klinikum der Universität Regensburg
City
Regensburg
ZIP/Postal Code
93047
Country
Germany
Facility Name
Krankenhaus der Barmherzigen Brüder
City
Regensburg
ZIP/Postal Code
93047
Country
Germany
Facility Name
Universitätsklinik Ulm
City
ULM
Country
Germany
Facility Name
Ospedale Civile
City
Desio
ZIP/Postal Code
20033
Country
Italy
Facility Name
Ospedale Sacro Cuore Don Calabria
City
Negrar
Country
Italy
Facility Name
Casa Di Cura Citta Di Pavia
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Ospedale Clinicizzato San Donato
City
San Donato Milanese
ZIP/Postal Code
20097
Country
Italy
Facility Name
Policlinico San Donato
City
San Donato
Country
Italy
Facility Name
Onze Lieve Vrouwen Gasthuis
City
Amsterdam
ZIP/Postal Code
1060
Country
Netherlands
Facility Name
Hospital Garcia de Orta
City
Almada
Country
Portugal
Facility Name
Hospital Senhora da Oliveira
City
Guimaraes
Country
Portugal
Facility Name
St Peters Hospital
City
London
Country
United Kingdom
Facility Name
Musgrove Park Hospltal
City
Taunton
ZIP/Postal Code
TA1 4DY
Country
United Kingdom
Facility Name
Worthing And Southlands Hospital
City
Worthing
ZIP/Postal Code
NR20 4LB
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
20487351
Citation
Kolb C, Tzeis S, Sturmer M, Babuty D, Schwab JO, Mantovani G, Janko S, Aime E, Ocklenburg R, Sick P. Rationale and design of the OPTION study: optimal antitachycardia therapy in ICD patients without pacing indications. Pacing Clin Electrophysiol. 2010 Sep;33(9):1141-8. doi: 10.1111/j.1540-8159.2010.02790.x.
Results Reference
background
PubMed Identifier
25282033
Citation
Kolb C, Sturmer M, Sick P, Reif S, Davy JM, Molon G, Schwab JO, Mantovani G, Dan D, Lennerz C, Borri-Brunetto A, Babuty D. Reduced risk for inappropriate implantable cardioverter-defibrillator shocks with dual-chamber therapy compared with single-chamber therapy: results of the randomized OPTION study. JACC Heart Fail. 2014 Dec;2(6):611-9. doi: 10.1016/j.jchf.2014.05.015. Epub 2014 Oct 1.
Results Reference
result

Learn more about this trial

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

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