Atrial FibrillationNCT04683692
A Study to Assess the Use of The Sentinel Device During Atrial Fibrillation Ablation
A study testing Magnetic Resonance Imaging (MRI) and Laboratory Testing in people with Atrial Fibrillation, run by Mayo Clinic at 1 site in United States.
Trial summary
Researchers are determining whether the use of the Sentinel cerebral protection device during atrial fibrillation ablation will affect the occurrence of new cerebral infarcts in brain MRI. 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?
- Magnetic Resonance Imaging (MRI) and Laboratory Testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2023to Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over the age of 18 years undergoing radiofrequency or cryoballoon ablation for AF who provide informed consent will be included
Who cannot join
- Severe peripheral arterial disease that precludes deployment of Sentinel device
- Unable to undergo MRI brain due to the presence of an MRI noncompatible implanted device
- Unable or unwilling to provide informed consent.
- Known history of dementia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection During Atrial Fibrillation Ablation: MRI Imaging and Laboratory Sub-study
Researchers are determining whether the use of the Sentinel cerebral protection device during atrial fibrillation ablation will affect the occurrence of new cerebral infarcts in brain MRI. We are also studying if laboratory tests can be used to predict the rate of cerebral infarction and microbleeds in patients undergoing atrial fibrillation (AF) ablation procedures with and without use of the Sentinel Device.
Read the detailed description
Patients currently participating in the research study titled: "A Pilot Randomized Study of the Use of the Sentinel Device for Cerebral Protection during Atrial Fibrillation Ablation" will be asked to participate in this sub-study to collect additional MRI and laboratory data to support the main study. This study will assess the number, size and volume of new cerebral emboli in protected territories detected using MRI of the brain within 7 days after AF ablation in patients treated with the Sentinel device compared to controls not receiving the Sentinel device, and to assess if change in blood inflammatory markers is associated with silent cerebral lesions.
- Conditions
- Atrial Fibrillation
- Being tested
- Magnetic Resonance Imaging (MRI), Laboratory Testing
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Device
Cerebral MRI will be performed without gadolinium contrast using a 3 Tesla scanner prior to and 1 to 7 days after catheter ablation
Laboratory TestingOther
Laboratory blood testing to include high sensitivity CRP (hs-CRP), interleukin-6 (IL-6), NT-proBNP and high sensitivity troponin prior to and post-ablation
| Study group | Role | What they receive |
|---|---|---|
| Cerebral protection with the Sentinel device | Experimental | Subjects who received the Sentinel device in the parent study Receives: Device: Magnetic Resonance Imaging (MRI); Other: Laboratory Testing |
| Control group without cerebral protection | Active comparator | Subjects who did not received the Sentinel device in the parent study Receives: Device: Magnetic Resonance Imaging (MRI); Other: Laboratory Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
New cerebral infarcts
Total number of new cerebral infarcts in the protected territories detected on brain MRI after ablation in the Sentinel device group vs control group
Measured: day 1 to 7 after atrial fibrillation ablation
Change in high sensitivity CRP (hs-CRP)
High sensitivity CRP (hs-CRP) measured in mg/L to detect changes in peripheral markers of inflammation
Measured: baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation
Change in interleukin-6 (IL-6)
Interleukin-6 measured in pg/ml to detect changes in peripheral markers of inflammation
Measured: baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation
Change in NT-proBNP
NT-proBNP measured in pg/ml to detect changes in tissue damage
Measured: baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation
Change in high sensitivity troponin
High sensitivity troponin measure in ng/mL to detect changes in tissue damage
Measured: baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2020
- Study startMar 2023 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: This sub-study was combined to the parent study protocol (NCT04685317)
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.
- More trials run by Mayo ClinicThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parent Study Design: Patients undergoing clinically indicated catheter ablation for AF in the parent study will be randomized 2:1 to two arms: (1) cerebral protection with the Sentinel device and (2) control group without cerebral protection
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, Ammar M. Killu, Mayo Clinic
- Investigators
- Ammar Killu, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04683692
- Sponsor's protocol ID
- 20-001308
- Status last verified
- Apr 2023
- First submitted
- 25 Sep 2020
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection During Atrial Fibrillation Ablation: MRI Imaging and Laboratory Sub-study
- ClinicalTrials.gov ID
- NCT04683692
- Acronym / sponsor ID
- 20-001308
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This sub-study was combined to the parent study protocol (NCT04685317)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Mar 2023 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 24 Dec 2020 (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.
Researchers are determining whether the use of the Sentinel cerebral protection device during atrial fibrillation ablation will affect the occurrence of new cerebral infarcts in brain MRI. We are also studying if laboratory tests can be used to predict the rate of cerebral infarction and microbleeds in patients undergoing atrial fibrillation (AF) ablation procedures with and without use of the Sentinel Device.
Detailed description
Patients currently participating in the research study titled: "A Pilot Randomized Study of the Use of the Sentinel Device for Cerebral Protection during Atrial Fibrillation Ablation" will be asked to participate in this sub-study to collect additional MRI and laboratory data to support the main study. This study will assess the number, size and volume of new cerebral emboli in protected territories detected using MRI of the brain within 7 days after AF ablation in patients treated with the Sentinel device compared to controls not receiving the Sentinel device, and to assess if change in blood inflammatory markers is associated with silent cerebral lesions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parent Study Design: Patients undergoing clinically indicated catheter ablation for AF in the parent study will be randomized 2:1 to two arms: (1) cerebral protection with the Sentinel device and (2) control group without cerebral protection
| Arm | Type | Receives |
|---|---|---|
| Cerebral protection with the Sentinel device | Experimental | Device: Magnetic Resonance Imaging (MRI), Other: Laboratory TestingSubjects who received the Sentinel device in the parent study |
| Control group without cerebral protection | Active comparator | Device: Magnetic Resonance Imaging (MRI), Other: Laboratory TestingSubjects who did not received the Sentinel device in the parent study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over the age of 18 years undergoing radiofrequency or cryoballoon ablation for AF who provide informed consent will be included
Key exclusion criteria (4 listed)
- Severe peripheral arterial disease that precludes deployment of Sentinel device
- Unable to undergo MRI brain due to the presence of an MRI noncompatible implanted device
- Unable or unwilling to provide informed consent.
- Known history of dementia.
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 |
|---|---|---|
| Magnetic Resonance Imaging (MRI)Cerebral MRI will be performed without gadolinium contrast using a 3 Tesla scanner prior to and 1 to 7 days after catheter ablation | Device | Cerebral protection with the Sentinel device, Control group without cerebral protection |
| Laboratory TestingLaboratory blood testing to include high sensitivity CRP (hs-CRP), interleukin-6 (IL-6), NT-proBNP and high sensitivity troponin prior to and post-ablation | Other | Cerebral protection with the Sentinel device, Control group without cerebral protection |
Primary outcome
New cerebral infarcts
Time frame: day 1 to 7 after atrial fibrillation ablation
Total number of new cerebral infarcts in the protected territories detected on brain MRI after ablation in the Sentinel device group vs control group
Change in high sensitivity CRP (hs-CRP)
Time frame: baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation
High sensitivity CRP (hs-CRP) measured in mg/L to detect changes in peripheral markers of inflammation
Change in interleukin-6 (IL-6)
Time frame: baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation
Interleukin-6 measured in pg/ml to detect changes in peripheral markers of inflammation
Change in NT-proBNP
Time frame: baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation
NT-proBNP measured in pg/ml to detect changes in tissue damage
Change in high sensitivity troponin
Time frame: baseline 1 - 30 days prior to ablation, days 1 - 7 after atrial fibrillation ablation
High sensitivity troponin measure in ng/mL to detect changes in tissue damage
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 14 Apr 2023.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Atrial Fibrillation (AF)
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.
Ammar Killu, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic Resonance Imaging (MRI) and Laboratory Testing in people with Atrial Fibrillation, run by Mayo Clinic 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 4 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 14 Apr 2023. 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.
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?
New cerebral infarcts (time frame: day 1 to 7 after atrial fibrillation ablation). The study lists 5 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 14 Apr 2023.