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

NCT00729703 | Completed Phase 4 DMC

• 1 other identifier: OPTION - ITAC03
• Study Type: interventional
• Target: 462
• Locations: 9 countries
• Sites: 55

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.

Conditions

Tachycardia

Keywords

ICD; Minimized; ventricular; pacing; indication; Clinical outcome; Inappropriate shock

Outcome Measures

Primary Outcomes (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.

  implant, 3 months, 9 months, 15 months, 21 months and 27 months

Secondary Outcomes (15)

• all cause mortality and cardio-vascular related mortality

  27 months follow up

• Hospitalizations due to cardio-vascular event (specified for each type of event)

  27 months follow up

• Time to first occurrence of inappropriate ICD shock therapy

  27 months follow up

• Evaluation of the impact of the different therapies on quality of life and heart failure status

  27 months follow up

• Sensitivity and specificity for VT/SVT discrimination for the first 100 patients in each group.

  27 months

Study Arms (2)

1

EXPERIMENTAL

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

2

EXPERIMENTAL

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

Interventions

OVATIO DR 6550 DEVICE

Dual-chamber ICD therapy with minimized ventricular pacing

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• LivaNova: lead

Study Sites (55)

Piedmont Hospital Research Institute

Atlanta, Georgia, 30303, United States

Location

Atlanta Va Medical Center

Decatur, Georgia, 30301, United States

Location

Southern Medical Research, Llc

Mandeville, Louisiana, 70471, United States

Location

River City Cardiology

Jeffersonville, Ohio, 43128, United States

Location

Pee Dee Cardiology

Florence, South Carolina, 29501, United States

Location

Algemeen Ziekenhuis - Antwepen

Antwepen, 2600, Belgium

Location

Kliniek Maria Middelares - Gent

Ghent, 9050, Belgium

Location

Heart Center Virga Jesse Ziekenhuis - Hasselt

Hasselt, 3500. 64, Belgium

Location

CHUM Hotel-Dieu

Montreal, H4Y 1H1, Canada

Location

Hôpital Sacré Coeur

Montreal, Canada

Location

Centre Hospitalier General

Aix-en-Provence, France

Location

CHU Le Haut L'Evêque

Bordeaux, 33000, France

Location

CHU Hôpital Michallon Grenoble

Grenoble, France

Location

Clinique De Parly II

Le Chesnay, 78150, France

Location

Clinique les sources

Le Mans, France

Location

CH ST Philibert

Lomme, France

Location

Hôpital St Joseph

Lyon, 69000, France

Location

Hopital Arnaud De Villeneuve

Montpellier, 34294, France

Location

CHU Nantes

Nantes, 44000, France

Location

Clinique Bizet

Paris, 75016, France

Location

CH Pau

Pau, 64000, France

Location

CHU Charles Nicolle

Rouen, 76000, France

Location

Clinique Pasteur

Toulouse, 31000, France

Location

Hôpital Rangueil

Toulouse, 31000, France

Location

CHU Purpan Toulouse

Toulouse, France

Location

CHU Tours

Tours, France

Location

Herzkreislaufklinik

Bad Bevensen, Germany

Location

Kerckhoff Klinik

Bad Nauheim, 61231, Germany

Location

Charite Campus Virchow

Berlin, 13353, Germany

Location

Universitätskliniken Bonn

Bonn, Germany

Location

Klinikum Coburg

Coburg, 96465, Germany

Location

Klinikum Garmisch-Partenkirchen

Garmisch-Partenkirchen, 82467, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 2100, Germany

Location

Universität des Saarlandes

Homburg, Germany

Location

Universitatsklinikum Schleswig-Holstein Campus Lübeck

Lübeck, 23501, Germany

Location

Kardiologische Gemeinschaftspraxis

München, 80337, Germany

Location

Universitatsklinikum Grosshadern

München, 81000, Germany

Location

DHZ Munchen

München, Germany

Location

Klinikum Bogenhausen

München, Germany

Location

Klinikum rechts der Isar

München, Germany

Location

Uniklinik Munster

Münster, Germany

Location

Klinikum der Universität Regensburg

Regensburg, 93047, Germany

Location

Krankenhaus der Barmherzigen Brüder

Regensburg, 93047, Germany

Location

Universitätsklinik Ulm

Ulm, Germany

Location

Ospedale Civile

Desio, 20033, Italy

Location

Ospedale Sacro Cuore Don Calabria

Negrar, Italy

Location

Casa Di Cura Citta Di Pavia

Pavia, 27100, Italy

Location

Policlinico San Donato

San Donato, Italy

Location

Ospedale Clinicizzato San Donato

San Donato Milanese, 20097, Italy

Location

Onze Lieve Vrouwen Gasthuis

Amsterdam, 1060, Netherlands

Location

Hospital Garcia de Orta

Almada, Portugal

Location

Hospital Senhora da Oliveira

Guimarães, Portugal

Location

St Peters Hospital

London, United Kingdom

Location

Musgrove Park Hospltal

Taunton, TA1 4DY, United Kingdom

Location

Worthing And Southlands Hospital

Worthing, NR20 4LB, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 20487351 BACKGROUND

• 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.

  PMID: 25282033 RESULT

MeSH Terms

Conditions

Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kolb

  Deutsches Herzzentrum München

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2008
• First Posted: August 7, 2008
• Study Start: June 1, 2006
• Primary Completion: December 1, 2011
• Study Completion: October 1, 2013
• Last Updated: January 13, 2015

Record last verified: 2015-01

Locations

US (5); BE (3); DE (18); PT (2); NL (1); FR (16); CA (2); IT (5); GB (3)