Feature Assessment Study for Indications Based Programming

Completed

• Conditions: Ventricular Tachycardia; Ventricular Flutter; Ventricular Fibrillation; Heart Failure

• Registration Number: NCT00711893
• Lead Sponsor: Boston Scientific Corporation

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"

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-07
• Study First Submitted QC: 2008-07-07
• Study First Posted: 2008-07-09
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-17
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 301

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients that are programmed by the physician to anything other than the recommended IBP setting	6 Months

Secondary Outcome Measures

Name	Time	Method
- 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

Trial Locations

Locations (28)

KH der Elisabethinen Linz; 🇦🇹 Linz, Austria

KH der Barmherzigen Schwestern Ried/Innkreis; 🇦🇹 Ried, Austria

Hartcentrum Hasselt - Dienst Cardiologie; 🇧🇪 Hasselt, Belgium

Prince of Wales Hospital; 🇨🇳 Hong Kong, Hong Kong, China

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, France

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