Atrial FibrillationPhase 1NCT03239444
Foresight Intracardiac Echocardiography System (ICE)
A Phase 1 study testing Intracardiac echocardiography imaging in people with Atrial Fibrillation, run by Conavi at 1 site in Canada.
Trial summary
This study will evaluate the efficacy of the Foresight Intracardiac Echocardiography system ,with improved image quality, in guiding trans-septal punctures during atrial fibrillation ablation procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Intracardiac echocardiography imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- 24 Apr 2017to 24 Dec 2018
- Phase
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is at least 18 years old.
- Patient is undergoing an atrial fibrillation ablation procedure.
- Patient has a transesophageal echocardiogram (TEE) within the 48 hours prior to ablation procedure to rule out left atrial thrombus.
- Patient provides informed, written consent for participation in the study.
Who cannot join
- Patients in whom placement of an ICE catheter in the right atrium for adequate atrial visualization is not technically feasible (as evaluated and determined by the physician/study investigator performing the procedure).
- Patients in whom transseptal puncture is relatively contraindicated.
- Patients in whom left atrial clot or dense spontaneous contrast is identified on TEE, which would increase thromboembolic risk.
- Women of child bearing potential, in whom pregnancy cannot be excluded.
- Patients unable to grant informed, written consent for participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Visualization of Human Cardiovascular Anatomy With Foresight Intracardiac Echocardiography (ICE) System
This study will evaluate the efficacy of the Foresight Intracardiac Echocardiography system ,with improved image quality, in guiding trans-septal punctures during atrial fibrillation ablation procedures.
Read the detailed description
The study will recruit 10 patients at a single center.
- Conditions
- Atrial Fibrillation
- Being tested
- Intracardiac echocardiography imaging
- Keywords
- ICE, Ablation, Trans-septal, Septum, Echocardiography
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracardiac echocardiography imagingDevice
Wide visualization of the the heart anatomy and additional devices used during atrial fibrillation ablation procedures.
| Study group | Role | What they receive |
|---|---|---|
| Assigned Intervention | Other | Device: Foresight ICE System The Foresight ICE System is composed of a sterile, single-use catheter intended to operate with a Foresight ICE PIM and Hummingbird console. The Foresight ICE system will be used in guiding the physician during the trans-septal puncture and provide physiological information during the course of the procedure. Receives: Device: Intracardiac echocardiography imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the study device for guiding transseptal puncture in order to gain access to the left atrium of the heart during an ablation procedure in patients suffering with atrial fibrillation.
The ability of the study device to identify the atrial septum during transseptal puncture will be evaluated by the physician on the day of the procedure and captured in the individual case report form. This will be based on the objective finding of whether the transseptal puncture was performed (Yes or No) under study device guidance. This information will be gathered for each patient in the individual case report form and presented qualitatively and as quantitative measures (percentage success).
Measured: For each patient, the individual physician satisfaction survey will be completed on the day of the procedure.
Secondary outcomes (1)
Collection of first human images with Conavi's Foresight System.
The Conavi's Foresight System will be utilized to capture images of relevant human cardiac anatomical landmarks (e.g. crista terminalis, tricuspid valve, coronary sinus) while the catheter will be manipulated inside the heart during the procedure. The physician satisfaction survey will ask the physician to specifically tabulate structures that could be identified in a binary yes/no format.
This kind of information will be gathered for each patient in the individual physician satisfaction surveys and presented qualitatively.
Measured: An individual physician satisfaction survey will be completed for each case on the day of the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start24 Apr 2017
- Primary completion24 Dec 2018
- Study completion24 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies 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 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Conavi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Atul Verma, MD, Principal investigator, Southlake Regional Health Center, Newmarket, Ontario, Canada, L3Y2P6
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239444
- Sponsor's protocol ID
- EXT-001-1.5
- Status last verified
- Jul 2017
- First submitted
- 24 Jul 2017
- Last updated
- 23 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualization of Human Cardiovascular Anatomy With Foresight Intracardiac Echocardiography (ICE) System
- ClinicalTrials.gov ID
- NCT03239444
- Acronym / sponsor ID
- EXT-001-1.5
- Conditions
- Atrial Fibrillation
- Keywords
- ICE, Ablation, Trans-septal, Septum, Echocardiography
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- ConaviIndustry (pharma, biotech, devices)
- Study start
- 24 Apr 2017 (actual)
- Primary completion
- 24 Dec 2018 (actual)
- Study completion
- 24 Dec 2018 (actual)
- First posted
- 4 Aug 2017 (actual)
- 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 will evaluate the efficacy of the Foresight Intracardiac Echocardiography system ,with improved image quality, in guiding trans-septal punctures during atrial fibrillation ablation procedures.
Detailed description
The study will recruit 10 patients at a single center.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assigned Intervention | Other | Device: Intracardiac echocardiography imagingDevice: Foresight ICE System The Foresight ICE System is composed of a sterile, single-use catheter intended to operate with a Foresight ICE PIM and Hummingbird console. The Foresight ICE system will be used in guiding the physician during the trans-septal puncture and provide physiological information during the course of the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is at least 18 years old.
- Patient is undergoing an atrial fibrillation ablation procedure.
- Patient has a transesophageal echocardiogram (TEE) within the 48 hours prior to ablation procedure to rule out left atrial thrombus.
- Patient provides informed, written consent for participation in the study.
Key exclusion criteria (5 listed)
- Patients in whom placement of an ICE catheter in the right atrium for adequate atrial visualization is not technically feasible (as evaluated and determined by the physician/study investigator performing the procedure).
- Patients in whom transseptal puncture is relatively contraindicated.
- Patients in whom left atrial clot or dense spontaneous contrast is identified on TEE, which would increase thromboembolic risk.
- Women of child bearing potential, in whom pregnancy cannot be excluded.
- Patients unable to grant informed, written consent for participation in the 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 |
|---|---|---|
| Intracardiac echocardiography imagingWide visualization of the the heart anatomy and additional devices used during atrial fibrillation ablation procedures. | Device | Assigned Intervention |
Primary outcome
Evaluation of the study device for guiding transseptal puncture in order to gain access to the left atrium of the heart during an ablation procedure in patients suffering with atrial fibrillation.
Time frame: For each patient, the individual physician satisfaction survey will be completed on the day of the procedure.
The ability of the study device to identify the atrial septum during transseptal puncture will be evaluated by the physician on the day of the procedure and captured in the individual case report form. This will be based on the objective finding of whether the transseptal puncture was performed (Yes or No) under study device guidance. This information will be gathered for each patient in the individual case report form and presented qualitatively and as quantitative measures (percentage success).
1 secondary outcome
Collection of first human images with Conavi's Foresight System.
Time frame: An individual physician satisfaction survey will be completed for each case on the day of the procedure.
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 23 Jul 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.
Atul Verma, MD principal investigator
Southlake Regional Health Center, Newmarket, Ontario, Canada, L3Y2P6
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intracardiac echocardiography imaging in people with Atrial Fibrillation, run by Conavi 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 4 inclusion and 5 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 23 Jul 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 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 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 the study device for guiding transseptal puncture in order to gain access to the left atrium of the heart during an ablation procedure in patients suffering with atrial fibrillation. (time frame: For each patient, the individual physician satisfaction survey will be completed on the day of the procedure.). 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 23 Jul 2019.