Avoid DeliVering TherApies for Non-sustained Arrhythmias in ICD PatiEnts III

Phase 4

Completed

• Conditions: Heart Disease
• Interventions: Device: Implantable Defibrillator

• Registration Number: NCT00617175
• Lead Sponsor: Medtronic Bakken Research Center

Brief Summary

To demonstrate a reduction in the number of ventricular therapies (ATP and Shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (CL≤ 320ms) as a consequence of self-termination and better arrhythmia discrimination due to a greater number of R-R intervals necessary to detect ventricular events.

Detailed Description

Primary Objective:

The primary objective is to demonstrate a 20% reduction of ventricular therapies (ATP and Shocks) delivered for treating spontaneous arrhythmia episodes with a fast cycle length (CL ≤ 320 ms) by choosing a number of 30 out of 40 intervals to detect (NID) compared to a NID of 18 out of 24 in subjects with either Class I or IIA indication for ICD implantation, regardless of cardiac resynchronization capabilities.

Secondary Objectives:

1. Evaluate the percent reduction in the number of shocks delivered per subject for treating spontaneous episodes with a fast cycle length (CL ≤ 320 ms) and for spontaneous ventricular episodes.

2. Evaluate the efficacy of ATP in successfully treating spontaneous ventricular episodes (CL: 200ms-320ms) for subjects in primary and secondary prevention in both arms of the study.

3. Evaluate acceleration rate or degeneration into VF of spontaneous episodes (CL of 200ms-320ms) due to ATP therapy in the two study arms.

4. Compare the likelihood of syncopal events associated with spontaneous episodes with a fast cycle length (CL ≤ 320 ms).

5. Describe the economic impact and the quality of life consequences.

Study Timeline

• Study First Submitted: 2008-02-04
• Study First Submitted QC: 2008-02-14
• Study First Posted: 2008-02-15
• Study Start: 2008-03
• Primary Completion: 2011-12
• Study Completion: 2012-02
• Results First Submitted: 2012-08-30
• Results First Submitted QC: 2013-01-21
• Results First Posted: 2013-02-25
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-23
• Last Update Posted: 2016-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1902

Inclusion Criteria

• Either ICD or CRT+ICD indications (Class I-IIA) according to the current AHA / ACC / ESC guidelines.
• Previous implant of a Medtronic device including "ATP During Charging" feature for 15 days at the maximum.

Exclusion Criteria

• ICD replacements and upgrading.
• Brugada Syndrome, Long QT and HCM patients
• Ventricular tachyarrhythmia associated with reversible cause.
• Other electrical implantable devices (Neurostimulators, etc.).
• Subject's life expectancy less than 1 year.
• Subject on heart transplant list which is expected in less than 1 year.
• Subject is <18 years of age, or the subject is under a minimum age that is required as defined by local law
• Women who are pregnant or women of childbearing potential who are not on a reliable form of birth control.
• Unwillingness or inability to provide written informed consent.
• Enrolment in, or intention to participate in, another clinical trial.
• Inaccessibility to come to the study center for the follow-up visits.
• Mechanical tricuspid valve.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Short NID	Implantable Defibrillator	Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia
Long NID	Implantable Defibrillator	Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia

Primary Outcome Measures

Name	Time	Method
For the Primary Endpoint the Reduction of Ventricular Therapies (ATP and Shocks) Delivered for Treating Fast Spontaneous Arrhythmia Episodes Was Measured.	From enrollment to study completion or exit whichever occured first	for each patient, the exposure time was calculated as the period between randomization and until study completion or exit whichever occured first. Exposure times for all patients were then summed.; The rate of therapies was calculated as the sum of all therapies delivered in the study (for each arm) over the sum of exposure times \* 100.

Secondary Outcome Measures

Name	Time	Method
Evaluate the Percent Reduction in the Number of Shocks Delivered Per Subject for Treating Spontaneous Episodes With a Fast Cycle Length (CL < 320 ms) and for Spontaneous Ventricular Episodes.	end of study

Trial Locations

Locations (91)

CHR La Citadelle Liege; 🇧🇪 Liege, Belgium

Centre Hospitalier de Pau; 🇫🇷 Pau, France

A.O. Santa Croce e Carle; 🇮🇹 Cuneo, Italy

Ente Ospedaliero Ospedali Galliera - Genova; 🇮🇹 Genova, Italy

San Carlo Borromeo; 🇮🇹 Milano, Italy

Nuovo Osp. Civile S. Agostino; 🇮🇹 Modena, Italy

Ospedale Misericordia e Dolce; 🇮🇹 Prato, Italy

Ospedale S. Giacomo; 🇮🇹 Novi Ligure, Italy

Policlinico S. Matteo; 🇮🇹 Pavia, Italy

Azienda Complesso Ospedaliero San Filippo Neri; 🇮🇹 Roma, Italy

Ospedale Sant Eugenio; 🇮🇹 Roma, Italy

St. Antonius Ziekenhuis Nieuwegein; 🇳🇱 Nieuwegein, Netherlands

Bloemfontein Medi-Clinic; 🇿🇦 Bloemfontein, South Africa

Hospital Geral de Santo António; 🇵🇹 Porto, Portugal

Tyumen Cardiology Center; 🇷🇺 Tyumen, Russian Federation

Milpark Hospital; 🇿🇦 Johannesburg, South Africa

University of Cape Town - Groote Schuur Hospital; 🇿🇦 Cape Town, South Africa

Sunninghill Hospital; 🇿🇦 Johannesburg, South Africa

UNITAS Hospital; 🇿🇦 Pretoria, South Africa

Hospital General Universitario de Alicante; 🇪🇸 Alicante, Spain

Hospital General San Pedro de Alcantara; 🇪🇸 Caceres, Spain

Hospital General de Ciudad Real; 🇪🇸 Ciudad Real, Spain

Hospital de Donostia; 🇪🇸 Donostia-San Sebastian, Spain

Hospital Universitario La Paz; 🇪🇸 Madrid, Spain

Hospital Clinico de Malaga - Virgen de la Victoria; 🇪🇸 Malaga, Spain

Hospital Universitario Son Dureta; 🇪🇸 Palma Mallorca, Spain

Hospital Universitario de San Juan; 🇪🇸 San Juan de Alicante, Spain

Hospital Ntra. Sra. de la Candelaria; 🇪🇸 Santa Cruz de Tenerife, Spain

Hospital Universitario de Canarias; 🇪🇸 Santa Cruz de Tenerife, Spain

Hospital Virgen de La Salud; 🇪🇸 Toledo, Spain

Hospital Arnau de Vilanova; 🇪🇸 Valencia, Spain

Hospital de Txagorritxu; 🇪🇸 Vitoria / Gasteiz, Spain

King Fahd Armed Forces Hospital; 🇸🇦 Jeddah, Saudi Arabia

Hospital de Santa Maria; 🇵🇹 Lisboa, Portugal

KAS Gentofte; 🇩🇰 Hellerup, Denmark

Odense Universitets Hospital; 🇩🇰 Odense, Denmark

Ospedale Sandro Pertini; 🇮🇹 Roma, Italy

Presidio Ospedaliero di Venere; 🇮🇹 Carbonara, Bari, Italy

Kardiologisches Zentrum an der Klinik Rotes Kreuz; 🇩🇪 Frankfurt am Main, Germany

CHU Hôpital de Pontchaillou Rennes; 🇫🇷 Rennes, France

Zala County Hospital; 🇭🇺 Zalaegerszeg, Hungary

CH Rangueil Toulouse; 🇫🇷 Toulouse, France

Clinique Pasteur; 🇫🇷 Toulouse, France

SRH Wald-Klinikum Gera gGmbH; 🇩🇪 Gera, Germany

Universitätskliniken des Saarlandes; 🇩🇪 Homburg, Germany

Klinikum Dorothea Christiane Erxleben Quedlinburg; 🇩🇪 Quedlinburg, Germany

Ospedale Pugliese e Ciaccio; 🇮🇹 Catanzaro, Italy

Diakoniekrankenhaus Rotenburg; 🇩🇪 Rotenburg, Germany

Azienda.Ospedaliera.G.M. Lancisi; 🇮🇹 Ancona, Italy

Semmelweis University AOK; 🇭🇺 Budapest, Hungary

Chuvi-Xeral-Cíes; 🇪🇸 Vigo, Spain

Azienda Ospedaliera G. Rummo; 🇮🇹 Benevento, Italy

Ospedale Maggiore di Lodi; 🇮🇹 Lodi, Italy

P.O. di Montebelluna; 🇮🇹 Montebelluna, Italy

Osp. S. Maria degli Angeli - Pordenone; 🇮🇹 Pordenone, Italy

H. Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital General Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain

Cliniche Gavazzeni; 🇮🇹 Bergamo, Italy

Stab. Ospedaliero Di Summa-Perrino - Brindisi; 🇮🇹 Brindisi, Italy

Casa di Cura Mater Domini; 🇮🇹 Castellanza, Italy

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Istituto Ca' Granda-Niguarda; 🇮🇹 Milano, Italy

Medisch Spectrum Twente; 🇳🇱 Enschede, Netherlands

ULSS N.6 S. Bortolo - Vicenza; 🇮🇹 Vicenza, Italy

Hospital Garcia Orta, SA; 🇵🇹 Almada, Portugal

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Italy

Osp. S. Giovanni di Dio e Ruggi dAragona; 🇮🇹 Salerno, Italy

A.O. S.Maria della Misericordia; 🇮🇹 Udine, Italy

AZ. Osp. Ordine Mauriziano; 🇮🇹 Torino, Italy

Hospital Clinico Universitario de Valencia; 🇪🇸 Valencia, Spain

Vincent Pallotti Hospital; 🇿🇦 Cape Town, South Africa

Zoz Mswia; 🇵🇱 Bialystok, Poland

King Khalid Univ. Hospital - King Saud University; 🇸🇦 Riyadh, Saudi Arabia

NCN Nantes; 🇫🇷 Nantes Cedex 2, France

AZ Nikolaas; 🇧🇪 Sint-Niklaas, Belgium

Christiaan Barnard Memorial Hospital; 🇿🇦 Cape Town, South Africa

Hospital de Santa Marta; 🇵🇹 Lisboa, Portugal

Hopital St-Joseph; 🇧🇪 Gilly, Belgium

CHU Brugmann; 🇧🇪 Laken, Belgium

Turku University Central Hospital; 🇫🇮 Turku, Finland

Hôpital Michalon- CHU Grenoble; 🇫🇷 Grenoble, France

CHU Nantes - Hôpital Guillaume et René Laënnec; 🇫🇷 Nantes, France

Hopital de la Pitie Salpetriere; 🇫🇷 Paris, France

Klinikum Lüdenscheid; 🇩🇪 Lüdenscheid, Germany

Universität Rostock- Medizinische Fakultät; 🇩🇪 Rostock, Germany

Hospital Puerta de Hierro Majadahonda; 🇪🇸 Madrid, Spain

Hospital de Basurto - Bilbao; 🇪🇸 Bilbao, Spain

Hospital General Yagüe; 🇪🇸 Burgos, Spain

University of Bonn; 🇩🇪 Bonn, Germany

RWTH Aachen; 🇩🇪 Aachen, Germany

CHR Namur; 🇧🇪 Namur, Belgium