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

NCT ID: NCT00729703

Last Updated: 2015-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 462 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2013-10-31

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.

Conditions

Tachycardia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

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

Group Type: EXPERIMENTAL

Ovatio DR 6550

Intervention Type: DEVICE

Dual-chamber ICD therapy with minimized ventricular pacing

2

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

Group Type: EXPERIMENTAL

OVATIO DR 6550

Intervention Type: DEVICE

Single-chamber device therapy with settings which are common in clinical practice.

Interventions

Ovatio DR 6550

Dual-chamber ICD therapy with minimized ventricular pacing

Intervention Type: DEVICE

OVATIO DR 6550

Single-chamber device therapy with settings which are common in clinical practice.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

LivaNova

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kolb

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum München

Locations

Piedmont Hospital Research Institute

Atlanta, Georgia, United States

Atlanta Va Medical Center

Decatur, Georgia, United States

Southern Medical Research, Llc

Mandeville, Louisiana, United States

River City Cardiology

Jeffersonville, Ohio, United States

Pee Dee Cardiology

Florence, South Carolina, United States

Algemeen Ziekenhuis - Antwepen

Antwepen, , Belgium

Kliniek Maria Middelares - Gent

Ghent, , Belgium

Heart Center Virga Jesse Ziekenhuis - Hasselt

Hasselt, , Belgium

CHUM Hotel-Dieu

Montreal, , Canada

Hôpital Sacré Coeur

Montreal, , Canada

Centre Hospitalier General

Aix-en-Provence, , France

CHU Le Haut L'Evêque

Bordeaux, , France

CHU Hôpital Michallon Grenoble

Grenoble, , France

Clinique De Parly II

Le Chesnay, , France

Clinique les sources

Le Mans, , France

CH ST Philibert

Lomme, , France

Hôpital St Joseph

Lyon, , France

Hopital Arnaud De Villeneuve

Montpellier, , France

CHU Nantes

Nantes, , France

Clinique Bizet

Paris, , France

CH Pau

Pau, , France

CHU Charles Nicolle

Rouen, , France

Clinique Pasteur

Toulouse, , France

Hôpital Rangueil

Toulouse, , France

CHU Purpan Toulouse

Toulouse, , France

CHU Tours

Tours, , France

Herzkreislaufklinik

Bad Bevensen, , Germany

Kerckhoff Klinik

Bad Nauheim, , Germany

Charite Campus Virchow

Berlin, , Germany

Universitätskliniken Bonn

Bonn, , Germany

Klinikum Coburg

Coburg, , Germany

Klinikum Garmisch-Partenkirchen

Garmisch-Partenkirchen, , Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Universität des Saarlandes

Homburg, , Germany

Universitatsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, , Germany

Kardiologische Gemeinschaftspraxis

München, , Germany

Universitatsklinikum Grosshadern

München, , Germany

DHZ Munchen

München, , Germany

Klinikum Bogenhausen

München, , Germany

Klinikum rechts der Isar

München, , Germany

Uniklinik Munster

Münster, , Germany

Klinikum der Universität Regensburg

Regensburg, , Germany

Krankenhaus der Barmherzigen Brüder

Regensburg, , Germany

Universitätsklinik Ulm

Ulm, , Germany

Ospedale Civile

Desio, , Italy

Ospedale Sacro Cuore Don Calabria

Negrar, , Italy

Casa Di Cura Citta Di Pavia

Pavia, , Italy

Policlinico San Donato

San Donato, , Italy

Ospedale Clinicizzato San Donato

San Donato Milanese, , Italy

Onze Lieve Vrouwen Gasthuis

Amsterdam, , Netherlands

Hospital Garcia de Orta

Almada, , Portugal

Hospital Senhora da Oliveira

Guimarães, , Portugal

St Peters Hospital

London, , United Kingdom

Musgrove Park Hospltal

Taunton, , United Kingdom

Worthing And Southlands Hospital

Worthing, , United Kingdom

Countries

United States; Belgium; Canada; France; Germany; Italy; Netherlands; Portugal; United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 20487351 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25282033 (View on PubMed)

Other Identifiers

OPTION - ITAC03

Identifier Type: -

Identifier Source: org_study_id