Clinical trial NCT00711893: Feature Assessment Study for Indications Based Programming
Official title: Feature Assessment Study for Indications Based Programming
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Tachycardia
Ventricular Flutter
Ventricular Fibrillation
Heart Failure
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: Guidant Corporation
First posted: 2008-07-09
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients indicated for the implant of an cardioverter defibrillator or cardiac resynchronization defibrillator defibrillator.

Brief summary: The purpose of this evaluation is to assess the acceptance level of specific programming recommendations based on the patient's clinical needs and primary indications when using the feature 'Indications Based Programming' (IBP) available in the ZOOMVIEW Software Application for the TELIGEN DR / VR and COGNIS family of devices compared to daily life programming chosen by physicians.

Detailed description: "This study will focus on documenting the final parameter changes that are made in comparison to the IBP recommendations for a specific cardiovascular and arrhythmia history. It will therefore compare the device settings that were finally programmed during the last available follow up procedure to the last available parameter recommendations of IBP. IBP was designed to facilitate programming by providing customized parameter settings based on a patient's clinical needs and primary indication.

In order to further enhance the IBP feature for future device generations, additional data may be collected and evaluated on:

* Physician perception and satisfaction with the New User Interface (NUI) of the programming application;
* Motivation for adapting IBP recommendations for the final programming of the device;
* Device data that can be retrieved from patient data disks that may include but is not limited to, arrhythmia episode detail, pacing counter data; total and individual therapy data"

Eligibility criteria: Inclusion Criteria:

* indicated for implantation of an ICD or CRT-D device according local hospital implant criteria guidelines

  * Implanted or intended to be implanted with any CE-marked device approved for implant from the TELIGEN (single or dual chamber ICD) or COGNIS (CRT-D) family during first implant (no replacements)
  * Geographically stable patients who are available for follow-up at a study centre
  * Age 18 or above, or of legal age to give informed consent specific to national law

Exclusion Criteria:

Inability or refusal to sign the Patient Informed Consent

* Pregnant or planning to become pregnant
* Replacement device
* Enrolment in another clinical trial, study or evaluation
* Estimated life expectancy of less than six months per discretion of physician

Primary outcomes:
measure: Proportion of patients that are programmed by the physician to anything other than the recommended IBP setting
timeFrame: 6 Months
Secondary outcomes:
measure: - Degree of acceptance of IBP - Proportion parameters changed per patient - Differences between recommended and final programmed parameters - Total number of parameter changes from IBP recommendations - Frequency of changes made to a single parameter
timeFrame: 6 Months
Other outcomes:
Locations:
city: Linz
country: Austria
facility: KH der Elisabethinen Linz
city: Ried
country: Austria
facility: KH der Barmherzigen Schwestern Ried/Innkreis
city: Hasselt
country: Belgium
facility: Hartcentrum Hasselt - Dienst Cardiologie
city: Hong Kong
country: China
facility: Prince of Wales Hospital
state: Hong Kong
city: Brest
country: France
facility: EHRU de Brest - Hospital de la Cavale Blanche
city: Dijon
country: France
facility: CHU Dijon - Hospital du Bocage
city: Orléans
country: France
facility: CHR Orléans - Hospital la Source
city: Parly
country: France
facility: CMC Parly II
city: Saint Priest en Jarez
country: France
facility: CHU de St. Etienne-Hospital Nord
city: Tours Cedex
country: France
facility: CHU de Tours
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik GmbH
city: Erfurt
country: Germany
facility: Praxis Dres. Bischoff/Lang
city: Fulda
country: Germany
facility: Klinikum Fulda
city: Herne
country: Germany
facility: Marienhospital Herne
city: Kassel
country: Germany
facility: Klinikum Kassel
city: Meissen
country: Germany
facility: Praxis Schnabel der Praxisgemeinschaft Kardiologie Meissen
city: Nuernberg
country: Germany
facility: Klinikum Nuernberg
city: Quedlinburg
country: Germany
facility: Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH
city: Heraklion
country: Greece
facility: University Hospital of Heraklion
city: Riga
country: Latvia
facility: Paul Stradina Clinical University Hospital
city: Arnhem
country: Netherlands
facility: Ziekenhius Rijnstate Arnhem
city: Breda
country: Netherlands
facility: Amphia Ziekenhius Breda
city: Bratislava
country: Slovakia
facility: Narodny ustav srdcvych a cievnych chorob
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Palma de Mallorca
country: Spain
facility: Hospital Son Llatzer
city: Valladolid
country: Spain
facility: Clinico Universitario de Valladolid
city: Zaragoza
country: Spain
facility: Centro Miguel Servet
city: Geneva
country: Switzerland
facility: University Hospital of Geneva
Study officials:
affiliation: Klinikum Nuernberg
name: Konrad Goehl, MD
role: PRINCIPAL_INVESTIGATOR
References: