Congestive Heart FailurePhase 4NCT00396136
COSMO Post Approval Registry: Corox OTW Steroid LV Lead Monitoring
A Phase 4 study testing Corox OTW Steroid Left Ventricular Lead in people with Congestive Heart Failure, run by Biotronik, Inc. at 1 site in United States.
Trial summary
The objective of this post approval registry is to confirm the long-term safety and effectiveness of the Corox Over-the-wire (OTW) Steroid Left Ventricular (LV) lead as used in conjunction with a BIOTRONK cardiac resynchronization therapy defibrillator (CRT-D). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- Corox OTW Steroid Left Ventricular Lead
- Type of treatment
- Medical device
- How many people
- 221 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2006to Dec 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Successfully implanted BIOTRONIK CRT-D system, including the Corox OTW Steroid LV Lead, from 1-30 days prior to enrollment
- Able to understand the nature of the registry and give informed consent
- Available for follow-up visits on a regular basis at the investigational site
- Age greater than or equal to 18 years
Who cannot join
- Enrolled in another cardiovascular or pharmacological clinical investigation
- Planned cardiac surgical procedures or interventional measures within the next 6 months
- Expected to receive a heart transplant within 6 months
- Life expectancy less than 6 months
- Presence of another life-threatening, underlying illness separate from their cardiac disorder
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Corox OTW Steroid LV Lead Monitoring
The objective of this post approval registry is to confirm the long-term safety and effectiveness of the Corox Over-the-wire (OTW) Steroid Left Ventricular (LV) lead as used in conjunction with a BIOTRONK cardiac resynchronization therapy defibrillator (CRT-D). The Corox OTW Steroid LV Lead is capable of providing permanent pacing therapy to the left ventricle in a CRT-D system. The following are the specific objectives to be evaluated during this post-approval registry:
- Long-term effectiveness of the COROX OTW Steroid in providing biventricular pacing
- Safety of the COROX OTW Steroid LV pacing lead
Read the detailed description
This post approval registry enrolled 221 patients from 34 centers. The collection of registry data continued for three years for each enrolled subject. Potential patients were screened by the enrolling physician according to the detailed inclusion and exclusion criteria below.
The specific required visits for this registry are: Enrollment, Three-month, Six month, One-year, Routine Follow-Ups (every subsequent 6 months), Interim follow-ups for Corox OTW Steroid LV lead related visits, and Out of Service visit. Data will be collected at each patient follow-up. The programmed pacing parameters, LV pacing impedance, and LV pacing threshold measurement at 0.5ms pulse width will be obtained. The programming parameters will be set to best suit each patient. If adequate system function, including effective CRT, cannot be obtained, the patient should not be selected for the registry.
- Conditions
- Congestive Heart Failure
- Being tested
- Corox OTW Steroid Left Ventricular Lead
- Keywords
- Congestive Heart Failure, Cardiac Resynchronization Therapy, Left Ventricular Lead
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corox OTW Steroid Left Ventricular LeadDevice
This is a registry: no study required interventions necessary.
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term Effectiveness of the COROX Over-the-wire (OTW) Steroid in Providing Biventricular Pacing
Evaluate threshold voltage of the COROX OTW Unipolar Lead.
Measured: All follow-ups for 3 years post implant
Safety of the COROX OTW Steroid LV Pacing Lead
Number of participants with LV lead related adverse events requiring additional invasive intervention to resolve.
Measured: 3 years post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2006 (estimated)
- Study startOct 2006
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Congestive 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 221 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biotronik, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Katerina de Metz, Study director, Biotronik, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396136
- Sponsor's protocol ID
- 20061550
- Status last verified
- Apr 2012
- First submitted
- 1 Nov 2006
- Last updated
- 28 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corox OTW Steroid LV Lead Monitoring
- ClinicalTrials.gov ID
- NCT00396136
- Acronym / sponsor ID
- 20061550
- Conditions
- Congestive Heart Failure
- Keywords
- Congestive Heart Failure, Cardiac Resynchronization Therapy, Left Ventricular Lead
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 221 participants (actual)
- Lead sponsor
- Biotronik, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 6 Nov 2006 (estimated)
- Results
- Posted 28 May 2012
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 this post approval registry is to confirm the long-term safety and effectiveness of the Corox Over-the-wire (OTW) Steroid Left Ventricular (LV) lead as used in conjunction with a BIOTRONK cardiac resynchronization therapy defibrillator (CRT-D). The Corox OTW Steroid LV Lead is capable of providing permanent pacing therapy to the left ventricle in a CRT-D system. The following are the specific objectives to be evaluated during this post-approval registry:
- Long-term effectiveness of the COROX OTW Steroid in providing biventricular pacing
- Safety of the COROX OTW Steroid LV pacing lead
Detailed description
This post approval registry enrolled 221 patients from 34 centers. The collection of registry data continued for three years for each enrolled subject. Potential patients were screened by the enrolling physician according to the detailed inclusion and exclusion criteria below.
The specific required visits for this registry are: Enrollment, Three-month, Six month, One-year, Routine Follow-Ups (every subsequent 6 months), Interim follow-ups for Corox OTW Steroid LV lead related visits, and Out of Service visit. Data will be collected at each patient follow-up. The programmed pacing parameters, LV pacing impedance, and LV pacing threshold measurement at 0.5ms pulse width will be obtained. The programming parameters will be set to best suit each patient. If adequate system function, including effective CRT, cannot be obtained, the patient should not be selected for the registry.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Successfully implanted BIOTRONIK CRT-D system, including the Corox OTW Steroid LV Lead, from 1-30 days prior to enrollment
- Able to understand the nature of the registry and give informed consent
- Available for follow-up visits on a regular basis at the investigational site
- Age greater than or equal to 18 years
Key exclusion criteria (6 listed)
- Enrolled in another cardiovascular or pharmacological clinical investigation
- Planned cardiac surgical procedures or interventional measures within the next 6 months
- Expected to receive a heart transplant within 6 months
- Life expectancy less than 6 months
- Presence of another life-threatening, underlying illness separate from their cardiac disorder
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 |
|---|---|---|
| Corox OTW Steroid Left Ventricular LeadThis is a registry: no study required interventions necessary. | Device | – |
Primary outcome
Long-term Effectiveness of the COROX Over-the-wire (OTW) Steroid in Providing Biventricular Pacing
Time frame: All follow-ups for 3 years post implant
Evaluate threshold voltage of the COROX OTW Unipolar Lead.
Safety of the COROX OTW Steroid LV Pacing Lead
Time frame: 3 years post implant
Number of participants with LV lead related adverse events requiring additional invasive intervention to resolve.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Katerina de Metz study director
Biotronik, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Corox OTW Steroid Left Ventricular Lead in people with Congestive Heart Failure, run by Biotronik, Inc. at 1 site in United States.
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 6 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 28 May 2012. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Long-term Effectiveness of the COROX Over-the-wire (OTW) Steroid in Providing Biventricular Pacing (time frame: All follow-ups for 3 years post implant). The study lists 2 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 28 May 2012.