Ventricular TachycardiaFASt-IBPNCT00711893
Feature Assessment Study for Indications Based Programming
An observational study of Ventricular Tachycardia and Ventricular Flutter, run by Boston Scientific Corporation at 28 sites in 11 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventricular Tachycardia, Ventricular Flutter, Ventricular Fibrillation
- What is being tested?
- Cognis 100-D, Teligen DR and VR 100 HE
- Type of treatment
- Medical device
- How many people
- 301 participants
- Where
- 28 sitesin 11 countries
- Study dates
- Jun 2008to Feb 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients indicated for the implant of an cardioverter defibrillator or cardiac resynchronization defibrillator defibrillator.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
28 sites in 11 countries.
28 sites in 11 countries
Germany8 sites
Kerckhoff-Klinik GmbH
Bad Nauheim, 61231
Praxis Dres. Bischoff/Lang
Erfurt, 99084
Klinikum Fulda
Fulda, 36043
Marienhospital Herne
Herne, 44625
Klinikum Kassel
Kassel, 34125
Praxis Schnabel der Praxisgemeinschaft Kardiologie Meissen
Meissen, 01662
Klinikum Nuernberg
Nuremberg, 90471
Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH
Quedlinburg, 06484
France6 sites
EHRU de Brest - Hospital de la Cavale Blanche
Brest, 29200
CHU Dijon - Hospital du Bocage
Dijon, 21000
CHR Orléans - Hospital la Source
Orléans, 45067
CMC Parly II
Parly, 78000
CHU de St. Etienne-Hospital Nord
Saint-Priest-en-Jarez, 42055
CHU de Tours
Tours, 37044
Spain4 sites
Hospital Universitario Central de Asturias
Oviedo, 33006
Hospital Son Llatzer
Palma de Mallorca, 07004
Clinico Universitario de Valladolid
Valladolid, 47005
Centro Miguel Servet
Zaragoza, 50012
Austria2 sites
KH der Elisabethinen Linz
Linz, 4010
KH der Barmherzigen Schwestern Ried/Innkreis
Ried, 4910
Netherlands2 sites
Ziekenhius Rijnstate Arnhem
Arnhem, 6815
Amphia Ziekenhius Breda
Breda, 4818
About this study
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.
Read the 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"
- Being tested
- Cognis 100-D, Teligen DR and VR 100 HE
- Medical subject headings
- Tachycardia, Ventricular, Ventricular Flutter, Ventricular Fibrillation, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognis 100-D, Teligen DR and VR 100 HEDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| ICD and CRT-D | Patients indicated for an implantable defibrillator or cardiac resynchronization defibrillator Receives: Device: Cognis 100-D, Teligen DR and VR 100 HE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients that are programmed by the physician to anything other than the recommended IBP setting
Measured: 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
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startJun 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular TachycardiaStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Guidant Corporation
- Responsible party
- Sponsor
- Investigators
- Konrad Goehl, MD, Principal investigator, Klinikum Nuernberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00711893
- Sponsor's protocol ID
- FASt-IBP 0408
- Other IDs
- feci 08/1644
- Acronym
- FASt-IBP
- Status last verified
- Feb 2017
- First submitted
- 7 Jul 2008
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feature Assessment Study for Indications Based Programming
- ClinicalTrials.gov ID
- NCT00711893
- Acronym / sponsor ID
- FASt-IBP / FASt-IBP 0408
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Guidant Corporation
- Study start
- Jun 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 9 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICD and CRT-D | – | Device: Cognis 100-D, Teligen DR and VR 100 HEPatients indicated for an implantable defibrillator or cardiac resynchronization defibrillator |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients indicated for the implant of an cardioverter defibrillator or cardiac resynchronization defibrillator defibrillator.
Key inclusion criteria (4 listed)
- indicated for implantation of an ICD or CRT-D device according local hospital implant criteria guidelines
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognis 100-D, Teligen DR and VR 100 HETeligen 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. | Device | ICD and CRT-D |
Primary outcome
Proportion of patients that are programmed by the physician to anything other than the recommended IBP setting
Time frame: 6 Months
1 secondary outcome
- 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
Time frame: 6 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Konrad Goehl, MD principal investigator
Klinikum Nuernberg
28 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Tachycardia and Ventricular Flutter, run by Boston Scientific Corporation at 28 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Germany, France, Spain, Austria, Netherlands and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients that are programmed by the physician to anything other than the recommended IBP setting (time frame: 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2017.