Heart FailureNCT00887055
OPTIMA Bi-ventricular Capture Verification Study
An observational study of Heart Failure, run by Guidant Corporation at 1 site in Canada.
Trial summary
The purpose of this study is to characterize the morphology (shape) of the intracardiac electrograms(EGM) from patients with a resynchronization therapy device. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- CRT device
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- 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
Who may be able to join
- Signed informed consent indicating a willingness to participate, have indications for and have been implanted with a Guidant Renewal 4 CRT-D device
Who cannot join
- Patients in atrial fibrillation that cannot be cardioverted for the study, sustained uncontrolled ventricular tachycardia (VT), sinus rhythm < 40 bpm or > 100 bpm, complete AV node block, AV node ablation, Severe aortic valve stenosis (valve area < 1.0 cm squared), frequent ectopic beats that would preclude adequate testing, lead in the great cardiac vein, women who are pregnant or who plan to become pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bi-ventricular Capture Verification Study
The purpose of this study is to characterize the morphology (shape) of the intracardiac electrograms(EGM) from patients with a resynchronization therapy device.
Read the detailed description
morphology of EGM during loss of capture in either right ventricle (RV) or left ventricle (LV) at different AV delays and LV offsets and during exercise. These EGM signals will be used to design and develop improved automatic threshold and automatic capture algorithms for CRT defibrillators (CRT-D). As well, the data collected from the study will be used to to develop other automatic algorithms for CRT-D, such as pacing parameter optimization.
- Conditions
- Heart Failure
- Being tested
- CRT device
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRT deviceDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
Why it stopped: never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guidant Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Francois Philippon, MD, Principal investigator, Hopital Laval, 2725 Chemin Ste-Foy, Ste-Foy, Quebec, Canada G1V 4G5 418-656-8711
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887055
- Sponsor's protocol ID
- OPTIMA
- Status last verified
- Jun 2015
- First submitted
- 22 Apr 2009
- Last updated
- 29 Jun 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bi-ventricular Capture Verification Study
- ClinicalTrials.gov ID
- NCT00887055
- Acronym / sponsor ID
- OPTIMA
- Conditions
- Heart Failure
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Guidant CorporationIndustry (pharma, biotech, devices)
- First posted
- 23 Apr 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 purpose of this study is to characterize the morphology (shape) of the intracardiac electrograms(EGM) from patients with a resynchronization therapy device.
Detailed description
morphology of EGM during loss of capture in either right ventricle (RV) or left ventricle (LV) at different AV delays and LV offsets and during exercise. These EGM signals will be used to design and develop improved automatic threshold and automatic capture algorithms for CRT defibrillators (CRT-D). As well, the data collected from the study will be used to to develop other automatic algorithms for CRT-D, such as pacing parameter optimization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Signed informed consent indicating a willingness to participate, have indications for and have been implanted with a Guidant Renewal 4 CRT-D device
Key exclusion criteria (1 listed)
- Patients in atrial fibrillation that cannot be cardioverted for the study, sustained uncontrolled ventricular tachycardia (VT), sinus rhythm < 40 bpm or > 100 bpm, complete AV node block, AV node ablation, Severe aortic valve stenosis (valve area < 1.0 cm squared), frequent ectopic beats that would preclude adequate testing, lead in the great cardiac vein, women who are pregnant or who plan to become pregnant.
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 |
|---|---|---|
| CRT device | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
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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.
Francois Philippon, MD principal investigator
Hopital Laval, 2725 Chemin Ste-Foy, Ste-Foy, Quebec, Canada G1V 4G5 418-656-8711
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure, run by Guidant Corporation at 1 site in Canada.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 was withdrawn before enrolling participants, so there are no results.
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.
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 29 Jun 2015.