Heart FailureEarly Phase 1NCT00577187
Placement of CS/LV Pacing Leads With EnSite NavX Guidance
A Early Phase 1 study testing EnSite NavX-Guided CRT implant in people with Heart Failure, run by Abbott Medical Devices at 1 site in United States.
Trial summary
This study utilizes the 3D mapping capabilities of the EnSite NavX mapping system to help guide the placement of the left ventricular lead during cardiovascular resynchronization therapy implant procedures with the goal of reducing fluoroscopic exposure and procedure time. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- EnSite NavX-Guided CRT implant
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Dec 2008
- Phase
- Early Phase 1
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients schedule to undergo CRT implant (per established guidelines)
Who cannot join
- Standard exclusions to CRT implant procedures
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Placement of Coronary Sinus/Left Ventricular Leads With EnSite NavX Guidance
This study utilizes the 3D mapping capabilities of the EnSite NavX mapping system to help guide the placement of the left ventricular lead during cardiovascular resynchronization therapy implant procedures with the goal of reducing fluoroscopic exposure and procedure time.
- Conditions
- Heart Failure
- Being tested
- EnSite NavX-Guided CRT implant
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnSite NavX-Guided CRT implantDevice
LV lead placement during CRT implant using EnSite NavX
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluoroscopy and procedure time
Measured: Procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startJun 2008
- Primary completionDec 2008 (estimated)
- Study completionDec 2008 (estimated)
Why it stopped: Lack of enrollment
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.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher C Erickson, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577187
- Sponsor's protocol ID
- 0712.0
- Status last verified
- Feb 2019
- First submitted
- 18 Dec 2007
- 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
- Placement of Coronary Sinus/Left Ventricular Leads With EnSite NavX Guidance
- ClinicalTrials.gov ID
- NCT00577187
- Acronym / sponsor ID
- 0712.0
- Conditions
- Heart Failure
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Dec 2008 (estimated)
- Study completion
- Dec 2008 (estimated)
- First posted
- 20 Dec 2007 (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.
This study utilizes the 3D mapping capabilities of the EnSite NavX mapping system to help guide the placement of the left ventricular lead during cardiovascular resynchronization therapy implant procedures with the goal of reducing fluoroscopic exposure and procedure time.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients schedule to undergo CRT implant (per established guidelines)
Key exclusion criteria (1 listed)
- Standard exclusions to CRT implant procedures
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 |
|---|---|---|
| EnSite NavX-Guided CRT implantLV lead placement during CRT implant using EnSite NavX | Device | – |
Primary outcome
Fluoroscopy and procedure time
Time frame: Procedural
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 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.
Christopher C Erickson, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing EnSite NavX-Guided CRT implant in people with Heart Failure, run by Abbott Medical Devices 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 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 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 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
What does the primary outcome measure?
Fluoroscopy and procedure time (time frame: Procedural). 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; AzTrials last refreshed its copy on 7 Nov 2026.