Feature Assessment Study for Indications Based Programming

Heart Failure Clinical Trial

— FASt-IBP  

Official title:

Feature Assessment Study for Indications Based Programming

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00711893
• Other study ID #: FASt-IBP 0408
• Secondary ID: feci 08/1644
• Status: Completed
• Phase: N/A
• First received: July 7, 2008
• Last updated: February 17, 2017
• Start date: June 2008
• Est. completion date: February 2010

Study information

• Verified date: February 2017
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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"

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation
• Ventricular Flutter
• Ventricular Tachycardia

Intervention

Device:
• Cognis 100-D, Teligen DR and VR 100 HE
Teligen is an implantable defibrillator for detection and termination of life threatening arrhythmias. Cognis includes in addition to these capabilities cardiac resynchronization therapy for patients having heart failure.

Locations

Country	Name	City	State
Austria	KH der Elisabethinen Linz	Linz
Austria	KH der Barmherzigen Schwestern Ried/Innkreis	Ried
Belgium	Hartcentrum Hasselt - Dienst Cardiologie	Hasselt
China	Prince of Wales Hospital	Hong Kong	Hong Kong
France	EHRU de Brest - Hospital de la Cavale Blanche	Brest
France	CHU Dijon - Hospital du Bocage	Dijon
France	CHR Orléans - Hospital la Source	Orléans
France	CMC Parly II	Parly
France	CHU de St. Etienne-Hospital Nord	Saint Priest en Jarez
France	CHU de Tours	Tours Cedex
Germany	Kerckhoff-Klinik GmbH	Bad Nauheim
Germany	Praxis Dres. Bischoff/Lang	Erfurt
Germany	Klinikum Fulda	Fulda
Germany	Marienhospital Herne	Herne
Germany	Klinikum Kassel	Kassel
Germany	Praxis Schnabel der Praxisgemeinschaft Kardiologie Meissen	Meissen
Germany	Klinikum Nuernberg	Nuernberg
Germany	Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH	Quedlinburg
Greece	University Hospital of Heraklion	Heraklion
Latvia	Paul Stradina Clinical University Hospital	Riga
Netherlands	Ziekenhius Rijnstate Arnhem	Arnhem
Netherlands	Amphia Ziekenhius Breda	Breda
Slovakia	Narodny ustav srdcvych a cievnych chorob	Bratislava
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Hospital Son Llatzer	Palma de Mallorca
Spain	Clinico Universitario de Valladolid	Valladolid
Spain	Centro Miguel Servet	Zaragoza
Switzerland	University Hospital of Geneva	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
Boston Scientific Corporation	Guidant Corporation

Countries where clinical trial is conducted

Austria,  Belgium,  China,  France,  Germany,  Greece,  Latvia,  Netherlands,  Slovakia,  Spain,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients that are programmed by the physician to anything other than the recommended IBP setting		6 Months
Secondary	- 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		6 Months