Feature Assessment Study for Indications Based Programming

NCT00711893 | Completed

• 2 other identifiers: FASt-IBP 0408feci 08/1644
• Study Type: observational
• Target: 301
• Locations: 11 countries
• Sites: 28

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.

Conditions

Ventricular Tachycardia; Ventricular Flutter; Ventricular Fibrillation; Heart Failure

Outcome Measures

Primary Outcomes (1)

• Proportion of patients that are programmed by the physician to anything other than the recommended IBP setting

  6 Months

Secondary Outcomes (1)

• - 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

Study Arms (1)

ICD and CRT-D

Patients indicated for an implantable defibrillator or cardiac resynchronization defibrillator

Device: Cognis 100-D, Teligen DR and VR 100 HE

Interventions

Cognis 100-D, Teligen DR and VR 100 HE DEVICE

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.

ICD and CRT-D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients indicated for the implant of an cardioverter defibrillator or cardiac resynchronization defibrillator defibrillator.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead
• Guidant Corporation: collaborator

Study Sites (28)

KH der Elisabethinen Linz

Linz, 4010, Austria

Location

KH der Barmherzigen Schwestern Ried/Innkreis

Ried, 4910, Austria

Location

Hartcentrum Hasselt - Dienst Cardiologie

Hasselt, 3500, Belgium

Location

Prince of Wales Hospital

Hong Kong, Hong Kong, China

Location

EHRU de Brest - Hospital de la Cavale Blanche

Brest, 29200, France

Location

CHU Dijon - Hospital du Bocage

Dijon, 21000, France

Location

CHR Orléans - Hospital la Source

Orléans, 45067, France

Location

CMC Parly II

Parly, 78000, France

Location

CHU de St. Etienne-Hospital Nord

Saint-Priest-en-Jarez, 42055, France

Location

CHU de Tours

Tours, 37044, France

Location

Kerckhoff-Klinik GmbH

Bad Nauheim, 61231, Germany

Location

Praxis Dres. Bischoff/Lang

Erfurt, 99084, Germany

Location

Klinikum Fulda

Fulda, 36043, Germany

Location

Marienhospital Herne

Herne, 44625, Germany

Location

Klinikum Kassel

Kassel, 34125, Germany

Location

Praxis Schnabel der Praxisgemeinschaft Kardiologie Meissen

Meissen, 01662, Germany

Location

Klinikum Nuernberg

Nuremberg, 90471, Germany

Location

Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH

Quedlinburg, 06484, Germany

Location

University Hospital of Heraklion

Heraklion, 71409, Greece

Location

Paul Stradina Clinical University Hospital

Riga, 1002, Latvia

Location

Ziekenhius Rijnstate Arnhem

Arnhem, 6815, Netherlands

Location

Amphia Ziekenhius Breda

Breda, 4818, Netherlands

Location

Narodny ustav srdcvych a cievnych chorob

Bratislava, 83348, Slovakia

Location

Hospital Universitario Central de Asturias

Oviedo, 33006, Spain

Location

Hospital Son Llatzer

Palma de Mallorca, 07004, Spain

Location

Clinico Universitario de Valladolid

Valladolid, 47005, Spain

Location

Centro Miguel Servet

Zaragoza, 50012, Spain

Location

University Hospital of Geneva

Geneva, 1211, Switzerland

Location

MeSH Terms

Conditions

Tachycardia, Ventricular; Ventricular Flutter; Ventricular Fibrillation; Heart Failure

Condition Hierarchy (Ancestors)

Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Konrad Goehl, MD

  Klinikum Nuernberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2008
• First Posted: July 9, 2008
• Study Start: June 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

DE (8); GR (1); FR (6); AU (2); LA (1); ES (4); CH (1); CN (1); BE (1); NL (2); SL (1)