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

Tachycardia Clinical Trial

— OPTION  

Official title:

Optimal Antitachycardia Therapy in ICD Patients Without Pacing Indications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00729703
• Other study ID #: OPTION - ITAC03
• Status: Completed
• Phase: Phase 4
• First received: August 4, 2008
• Last updated: January 12, 2015
• Start date: June 2006
• Est. completion date: October 2013

Study information

• Verified date: January 2015
• Source: LivaNova
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesItaly: Ethics CommitteeBelgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 462
• Est. completion date: October 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tachycardia

Intervention

Device:
• Ovatio DR 6550
Dual-chamber ICD therapy with minimized ventricular pacing
• OVATIO DR 6550
Single-chamber device therapy with settings which are common in clinical practice.

Locations

Country	Name	City	State
Belgium	Algemeen Ziekenhuis - Antwepen	Antwepen
Belgium	Kliniek Maria Middelares - Gent	Gent
Belgium	Heart Center Virga Jesse Ziekenhuis - Hasselt	Hasselt
Canada	CHUM Hotel-Dieu	Montreal
Canada	Hôpital Sacré Coeur	Montreal
France	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	CHU Purpan Toulouse	Toulouse
France	Clinique Pasteur	Toulouse
France	Hôpital Rangueil	Toulouse
France	CHU Tours	Tours
Germany	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	DHZ Munchen	Munchen
Germany	Klinikum Bogenhausen	Munchen
Germany	Klinikum rechts der Isar	Munchen
Germany	Kardiologische Gemeinschaftspraxis	München
Germany	Universitatsklinikum Grosshadern	München
Germany	Uniklinik Munster	Munster
Germany	Klinikum der Universität Regensburg	Regensburg
Germany	Krankenhaus der Barmherzigen Brüder	Regensburg
Germany	Universitätsklinik Ulm	ULM
Italy	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
Netherlands	Onze Lieve Vrouwen Gasthuis	Amsterdam
Portugal	Hospital Garcia de Orta	Almada
Portugal	Hospital Senhora da Oliveira	Guimaraes
United Kingdom	St Peters Hospital	London
United Kingdom	Musgrove Park Hospltal	Taunton
United Kingdom	Worthing And Southlands Hospital	Worthing
United States	Piedmont Hospital Research Institute	Atlanta	Georgia
United States	Atlanta Va Medical Center	Decatur	Georgia
United States	Pee Dee Cardiology	Florence	South Carolina
United States	River City Cardiology	Jeffersonville	Ohio
United States	Southern Medical Research, Llc	Mandeville	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
LivaNova

Countries where clinical trial is conducted

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

References & Publications (2)

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 — View Citation

Kolb C, Tzeis S, Sturmer M, Babuty D, Schwab JO, Mantovani G, Janko S, Aimé 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	all cause mortality and cardio-vascular related mortality		27 months follow up	Yes
Secondary	Hospitalizations due to cardio-vascular event (specified for each type of event)		27 months follow up	Yes
Secondary	Time to first occurrence of inappropriate ICD shock therapy		27 months follow up	No
Secondary	Evaluation of the impact of the different therapies on quality of life and heart failure status		27 months follow up	No
Secondary	Sensitivity and specificity for VT/SVT discrimination for the first 100 patients in each group.		27 months	No
Secondary	Inappropriate overall device reactions defined by inappropriate shock and/or ATP therapy or inappropriate therapy delay/inhibition > 2 minutes on VTs		27 months	No
Secondary	time to first documented AF occurrence and number of patients moving into permanent or persistent AF		27 months follow up	No
Secondary	Cardiac dimensions obtained by echo evaluation for a subset of patients of both groups		Baseline and 27 months	No
Secondary	Slow VT incidence		27 months	No
Secondary	Unscheduled visits and hospitalizations due to slow VT		27 months follow up	No
Secondary	System related complications including lead dislodgements, exit block, oversensing which requires programming corrections, infections, complications which require reintervention		27 months follow up	Yes
Secondary	Cumulative percentage of ventricular pacing and proportion of patients with 0% V pacing.		27 months follow up	No
Secondary	Overall success rate of ATP in the FVT zone		27 months	Yes
Secondary	Cost effectiveness of applied ICD therapy		27 months	No
Secondary	PPV and NPV for Tvar risk stratification		27 months	No