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

Heart Disease Clinical Trial

— ADVANCEIII  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00617175
• Other study ID #: ADVANCE III
• Secondary ID: ADVANCE III
• Status: Completed
• Phase: Phase 4
• First received: February 4, 2008
• Last updated: March 23, 2016
• Start date: March 2008
• Est. completion date: February 2012

Study information

• Verified date: March 2016
• Source: Medtronic Bakken Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1902
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Heart Disease

Intervention

Device:
• Implantable Defibrillator
Number of 30 out of 40 intervals to detect (NID)Fast Ventricular Tachycardia
• Implantable Defibrillator
number of 18 out of 24 intervals to detect (NID)Fast Ventricular Tachycardia

Locations

Country	Name	City	State
Belgium	Hopital St-Joseph	Gilly
Belgium	CHU Brugmann	Laken
Belgium	CHR La Citadelle Liege	Liege
Belgium	CHR Namur	Namur
Belgium	AZ Nikolaas	Sint-Niklaas
Denmark	KAS Gentofte	Hellerup
Denmark	Odense Universitets Hospital	Odense
Finland	Turku University Central Hospital	Turku
France	Hôpital Michalon- CHU Grenoble	Grenoble
France	CHU Nantes - Hôpital Guillaume et René Laënnec	Nantes
France	NCN Nantes	Nantes Cedex 2
France	Hopital de la Pitie Salpetriere	Paris
France	Centre Hospitalier de Pau	Pau
France	CHU Hôpital de Pontchaillou Rennes	Rennes
France	CH Rangueil Toulouse	Toulouse
France	Clinique Pasteur	Toulouse
Germany	RWTH Aachen	Aachen
Germany	University of Bonn	Bonn
Germany	Kardiologisches Zentrum an der Klinik Rotes Kreuz	Frankfurt am Main
Germany	SRH Wald-Klinikum Gera gGmbH	Gera
Germany	Universitätskliniken des Saarlandes	Homburg
Germany	Klinikum Lüdenscheid	Lüdenscheid
Germany	Klinikum Dorothea Christiane Erxleben Quedlinburg	Quedlinburg
Germany	Universität Rostock- Medizinische Fakultät	Rostock
Germany	Diakoniekrankenhaus Rotenburg	Rotenburg
Hungary	Semmelweis University AOK	Budapest
Hungary	Zala County Hospital	Zalaegerszeg
Italy	Azienda.Ospedaliera.G.M. Lancisi	Ancona
Italy	Azienda Ospedaliera G. Rummo	Benevento
Italy	Cliniche Gavazzeni	Bergamo
Italy	Stab. Ospedaliero Di Summa-Perrino - Brindisi	Brindisi
Italy	Presidio Ospedaliero di Venere	Carbonara	Bari
Italy	Casa di Cura Mater Domini	Castellanza
Italy	Ospedale Pugliese e Ciaccio	Catanzaro
Italy	A.O. Santa Croce e Carle	Cuneo
Italy	Ente Ospedaliero Ospedali Galliera - Genova	Genova
Italy	Ospedale Maggiore di Lodi	Lodi
Italy	Istituto Ca' Granda-Niguarda	Milano
Italy	San Carlo Borromeo	Milano
Italy	Nuovo Osp. Civile S. Agostino	Modena
Italy	P.O. di Montebelluna	Montebelluna
Italy	Ospedale S. Giacomo	Novi Ligure
Italy	Policlinico S. Matteo	Pavia
Italy	Osp. S. Maria degli Angeli - Pordenone	Pordenone
Italy	Ospedale Misericordia e Dolce	Prato
Italy	Azienda Complesso Ospedaliero San Filippo Neri	Roma
Italy	Ospedale Sandro Pertini	Roma
Italy	Ospedale Sant Eugenio	Roma
Italy	Istituto Clinico Humanitas	Rozzano
Italy	Osp. S. Giovanni di Dio e Ruggi dAragona	Salerno
Italy	AZ. Osp. Ordine Mauriziano	Torino
Italy	A.O. S.Maria della Misericordia	Udine
Italy	ULSS N.6 S. Bortolo - Vicenza	Vicenza
Netherlands	Medisch Spectrum Twente	Enschede
Netherlands	St. Antonius Ziekenhuis Nieuwegein	Nieuwegein
Poland	Zoz Mswia	Bialystok
Portugal	Hospital Garcia Orta, SA	Almada
Portugal	Hospital de Santa Maria	Lisboa
Portugal	Hospital de Santa Marta	Lisboa
Portugal	Hospital Geral de Santo António	Porto
Russian Federation	Tyumen Cardiology Center	Tyumen
Saudi Arabia	King Fahd Armed Forces Hospital	Jeddah
Saudi Arabia	King Khalid Univ. Hospital - King Saud University	Riyadh
South Africa	Bloemfontein Medi-Clinic	Bloemfontein
South Africa	Christiaan Barnard Memorial Hospital	Cape Town
South Africa	University of Cape Town - Groote Schuur Hospital	Cape Town
South Africa	Vincent Pallotti Hospital	Cape Town
South Africa	Milpark Hospital	Johannesburg
South Africa	Sunninghill Hospital	Johannesburg
South Africa	UNITAS Hospital	Pretoria
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital de Basurto - Bilbao	Bilbao
Spain	Hospital General Yagüe	Burgos
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 Virgen de las Nieves	Granada
Spain	H. Ramón y Cajal	Madrid
Spain	Hospital General Universitario Gregorio Marañón	Madrid
Spain	Hospital Puerta de Hierro Majadahonda	Madrid
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 Clinico Universitario de Valencia	Valencia
Spain	Chuvi-Xeral-Cíes	Vigo
Spain	Hospital de Txagorritxu	Vitoria / Gasteiz

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Countries where clinical trial is conducted

Belgium,  Denmark,  Finland,  France,  Germany,  Hungary,  Italy,  Netherlands,  Poland,  Portugal,  Russian Federation,  Saudi Arabia,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	For the Primary Endpoint the Reduction of Ventricular Therapies (ATP and Shocks) Delivered for Treating Fast Spontaneous Arrhythmia Episodes Was Measured.	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.	From enrollment to study completion or exit whichever occured first	No
Secondary	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	No