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

Completed · Phase 4

Conditions studied: Tachycardia

In brief

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.

Key facts

Study ID

NCT00729703

Run by

LivaNova

People needed

462

Starts

2006-06-01

Expected to finish

2013-10-01

Last updated by the study team

2015-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Unavailability for scheduled follow-up at the implanting or cooperating center.
• Age of less than 18 years.
• Pregnancy

Where it is running

• 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
• Piedmont Hospital Research Institute — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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