Ischemic Heart DiseaseNCT00949000
AnalyST Treadmill Study
A study testing ICD Implantation in people with Ischemic Heart Disease, run by Abbott Medical Devices at 5 sites in Germany.
Trial summary
The objective of the study is to collect information on the naturally occurring variations in ST deviations at different heart rates, as detected by the AnalyST and AnalyST Accel Implantable Cardioverter Defibrillators (ICD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- ICD Implantation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesGermany
- Study dates
- Jul 2009to Feb 2011
- Phase
- Interventional
- 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
Who may be able to join
- Patient has received or is scheduled to receive a St Jude Medical AnalyST or AnalyST Accel ICD;
- Patient has documented ischemic heart disease.
Who cannot join
- Patient has an indication for ventricular pacing;
- Patient has chronotropic incompetence or insufficiency;
- Patient has a contraindication to stress testing;
- Patient is physically unable to complete the stress test protocol;
- The patient has persistent or permanent atrial fibrillation (AF);
- Patient is unable to comply with the protocol and follow-up schedule based on geographic location or for any reason;
- Patient is pregnant;
- Patient is minor (< 18 years old).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Medizinische Einrichtungen der RWTH Aachen
Aachen, N. Rhin, 52074
Kerckhoff-Klinik
Bad Nauheim, Hesse, 61321
Klinikum Coburg
Coburg, Bavaria, 96450
Klinikum Luedenscheid
Lüdenscheid, N. Rhin, 58515
Klinikum der Stadt Ludwigshafen am Rhein
Ludwigshafen, N. Rhin, 67063
About this study
Official title: Clinical Evaluation of ST Segment Deviation Detection by SJM AnalyST and Analyst Accel Implantable Cardiac Defibrillators
The objective of the study is to collect information on the naturally occurring variations in ST deviations at different heart rates, as detected by the AnalyST and AnalyST Accel Implantable Cardioverter Defibrillators (ICD).
- Conditions
- Ischemic Heart Disease
- Being tested
- ICD Implantation
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICD ImplantationDevice
Implantation of a commercially available AnalyST or AnalyST Accel ICD
| Study group | Role | What they receive |
|---|---|---|
| ICD Implant | Other | Implantation of a commercially available AnalyST or AnalyST Accel ICD Receives: Device: ICD Implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of start and duration of isoelectric PR intervals
Measured: 4 weeks
Evaluation of start and duration of ST intervals
Measured: 4 weeks
Evaluation of ST segment deviations during stress testing across the 4 heart rate zones defined by the device
Measured: 4 weeks
Incidence of ischemic events detected based on the external ECG
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Christian Hamm, Prof. Dr., Principal investigator, Kerckhoff-Klinik, Bad Nauheim, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00949000
- Sponsor's protocol ID
- CR08018HV
- Status last verified
- Feb 2019
- First submitted
- 29 Jul 2009
- Last updated
- 4 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of ST Segment Deviation Detection by SJM AnalyST and Analyst Accel Implantable Cardiac Defibrillators
- ClinicalTrials.gov ID
- NCT00949000
- Acronym / sponsor ID
- CR08018HV
- Conditions
- Ischemic Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 30 Jul 2009 (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 objective of the study is to collect information on the naturally occurring variations in ST deviations at different heart rates, as detected by the AnalyST and AnalyST Accel Implantable Cardioverter Defibrillators (ICD).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICD Implant | Other | Device: ICD ImplantationImplantation of a commercially available AnalyST or AnalyST Accel ICD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient has received or is scheduled to receive a St Jude Medical AnalyST or AnalyST Accel ICD;
- Patient has documented ischemic heart disease.
Key exclusion criteria (8 listed)
- Patient has an indication for ventricular pacing;
- Patient has chronotropic incompetence or insufficiency;
- Patient has a contraindication to stress testing;
- Patient is physically unable to complete the stress test protocol;
- The patient has persistent or permanent atrial fibrillation (AF);
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 |
|---|---|---|
| ICD ImplantationImplantation of a commercially available AnalyST or AnalyST Accel ICD | Device | ICD Implant |
Primary outcome
Evaluation of start and duration of isoelectric PR intervals
Time frame: 4 weeks
Evaluation of start and duration of ST intervals
Time frame: 4 weeks
Evaluation of ST segment deviations during stress testing across the 4 heart rate zones defined by the device
Time frame: 4 weeks
Incidence of ischemic events detected based on the external ECG
Time frame: 4 weeks
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 4 Feb 2019.
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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.
Christian Hamm, Prof. Dr. principal investigator
Kerckhoff-Klinik, Bad Nauheim, Germany
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICD Implantation in people with Ischemic Heart Disease, run by Abbott Medical Devices at 5 sites in Germany.
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 2 inclusion and 8 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 4 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. 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?
Evaluation of start and duration of isoelectric PR intervals (time frame: 4 weeks). The study lists 4 primary outcomes in all. 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 4 Feb 2019.