Congestive Heart FailureBi-VNavXNCT01615835
EnSite NavX-Guided Coronary Sinus Mapping During CRT Implant
A study testing EnSite NavX System in people with Congestive Heart Failure, run by Abbott Medical Devices at 2 sites in United States.
Trial summary
Use of the EnSite NavX system to map the coronary vasculature during CRT implant Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- EnSite NavX System
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2007to Oct 2007
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet criteria for CRT implant including EF<35%, QRS>120ms, NYHA class III or IV
- Persistent CHF symptoms despite optimization
- Stable/optimal medical therapy
- History of ischemic or non-ischemic cardiomyopathy
Who cannot join
- Any standard device exclusion including TVR
- Positive pregnancy test
- Currently participating in IDE/IND study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical College of Georgia
Augusta, Georgia, 30912
Duke Medical Center
Durham, North Carolina, 27710
About this study
Official title: Mapping in the Coronary Sinus During Implant of a Bi-Ventricular Implantable Cardioverter Defibrillator Utilizing the NavX Mapping System
Use of the EnSite NavX system to map the coronary vasculature during CRT implant
Read the detailed description
Objective(s):
To determine the feasibility of CS mapping with NavX during Biventricular Implantable Cardioverter Defibrillator (BiV ICD) implantation.
Inclusion Criteria:
- Subject is between the age of 18 and 75 years
- Subject is willing and able to sign a study specific informed consent
- Subject is able to fulfill study requirements
- Meet the conventional criteria for implant of a BiV ICD, including; LVEF of ≤35%, QRS ≥ 120 ms and NYHA III-IV
- Have persistent CHF symptoms despite contemporary CHF medical therapy
- Stable and optimal medical therapy (stability is no changes in past 3 months).
- Documented history of ischemic or non-ischemic cardiomyopathy.
Exclusion Criteria:
- Have any standard device exclusions including tricuspid valve prosthesis/ replacement.
- Have a positive urine or serum pregnancy test (if female and of childbearing potential)
- Be currently participating in an IDE or IND study.
- Conditions
- Congestive Heart Failure
- Being tested
- EnSite NavX System
- 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 SystemOther
EnSite NavX system is a 3D Mapping system
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine feasibility of CS mapping with EnSite NavX during CRT implant
Measured: Procedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2012 (estimated)
- Study startApr 2007
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive 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
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Adam Berman, MD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01615835
- Sponsor's protocol ID
- 067.3
- Acronym
- Bi-VNavX
- Status last verified
- Feb 2019
- First submitted
- 21 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
- Mapping in the Coronary Sinus During Implant of a Bi-Ventricular Implantable Cardioverter Defibrillator Utilizing the NavX Mapping System
- ClinicalTrials.gov ID
- NCT01615835
- Acronym / sponsor ID
- Bi-VNavX / 067.3
- Conditions
- Congestive Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 11 Jun 2012 (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.
Use of the EnSite NavX system to map the coronary vasculature during CRT implant
Detailed description
Objective(s):
To determine the feasibility of CS mapping with NavX during Biventricular Implantable Cardioverter Defibrillator (BiV ICD) implantation.
Inclusion Criteria:
- Subject is between the age of 18 and 75 years
- Subject is willing and able to sign a study specific informed consent
- Subject is able to fulfill study requirements
- Meet the conventional criteria for implant of a BiV ICD, including; LVEF of ≤35%, QRS ≥ 120 ms and NYHA III-IV
- Have persistent CHF symptoms despite contemporary CHF medical therapy
- Stable and optimal medical therapy (stability is no changes in past 3 months).
- Documented history of ischemic or non-ischemic cardiomyopathy.
Exclusion Criteria:
- Have any standard device exclusions including tricuspid valve prosthesis/ replacement.
- Have a positive urine or serum pregnancy test (if female and of childbearing potential)
- Be currently participating in an IDE or IND study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet criteria for CRT implant including EF<35%, QRS>120ms, NYHA class III or IV
- Persistent CHF symptoms despite optimization
- Stable/optimal medical therapy
- History of ischemic or non-ischemic cardiomyopathy
Key exclusion criteria (3 listed)
- Any standard device exclusion including TVR
- Positive pregnancy test
- Currently participating in IDE/IND study
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 SystemEnSite NavX system is a 3D Mapping system | Other | – |
Primary outcome
Determine feasibility of CS mapping with EnSite NavX during CRT implant
Time frame: Procedural
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.
Adam Berman, MD principal investigator
Augusta University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EnSite NavX System in people with Congestive Heart Failure, run by Abbott Medical Devices at 2 sites 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 3 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 2 sites 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.
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?
Determine feasibility of CS mapping with EnSite NavX during CRT implant (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.