ArrhythmiaNCT04685317
Safety and Efficacy of the Sentinel Cerebral Protection Device in Atrial Fibrillation Ablation
A study testing Sentinel® Cerebral Protection System and Magnetic Resonance Imaging in people with Arrhythmia and Atrial Fibrillation, run by Malini Madhavan at 1 site in United States.
Trial summary
The purpose of the study is to see if the Sentinel® Cerebral Protection System may prevent occurrence of stroke during an ablation procedure for atrial fibrillation (AF). The secondary purpose of this study is to study if cognitive function after AF ablation differs between those treated with the Sentinel cerebral… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmia, Atrial Fibrillation
- What is being tested?
- Sentinel® Cerebral Protection System and Magnetic Resonance Imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2023to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Men / women over the age of 18 years undergoing radiofrequency, pulsed field or cryo-balloon ablation for AF in accordance with the current AHA/ACC/HRS guideline for management of patients with atrial fibrillation. This includes patients with symptomatic paroxysmal, persistent or long-standing persistent AF not responsive to or intolerant of a Class I or III anti-arrhythmic drug or patients with symptomatic paroxysmal or persistent AF prior to the initiation of a Class I or Class III antiarrhythmic drug). The decision to perform catheter ablation for AF will be made by the treating provider and the patient in accordance with the guidelines noted above. (January et al. J Am Coll Cardiol vol. 64, No. 21, 2014, page e1)
- Able to provide informed consent.
- Patients should have acceptable aortic arch anatomy and vessel diameters without significant stenosis as assessed using pre-procedure CT angiogram.
Who cannot join
- Anatomy unsuitable for use of Sentinel device:
- Right extremity vasculature not suitable due to compromised arterial blood flow.
- Brachiocephalic, left carotid or aortic arch not suitable due to excessive tortuosity, significant ectasia, stenosis (>70%), dissection or aneurysm.
- Cerebrovascular accident or transient ischemic attack within six months
- Carotid disease requiring treatment within six weeks
- Unable or unwilling to provide informed consent.
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- Pregnant women
- Known history of dementia.
- Known hypersensitivity to nickel-titanium.
- Presence of MRI non-compatible implanted devices including cardiac implantable electronic devices.
- The presence of left atrial thrombus. All patients routinely undergo transesophageal echocardiogram prior to ablation and / or intra-cardiac echocardiogram at the beginning of the ablation procedure to rule out the presence of left atrial thrombus.
- Patients with a reversible cause for AF such as hyperthyroidism.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Grace Purkey, (507) 255-0774, Purkey.Grace@mayo.edu
Malini Madhavan, MBBS
About this study
Official title: A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection During Atrial Fibrillation Ablation
The purpose of the study is to see if the Sentinel® Cerebral Protection System may prevent occurrence of stroke during an ablation procedure for atrial fibrillation (AF). The secondary purpose of this study is to study if cognitive function after AF ablation differs between those treated with the Sentinel cerebral protection device and those who do not receive the device.
Read the detailed description
If assigned to receive the device, the Sentinel® Cerebral Protection System will be placed in your heart at the beginning of your ablation procedure, and then removed along with any collected blood debris upon completion of your procedure. The study team will then call you 30 days after your procedure to assess any neurological events. Your final visit will be 90 days after your procedure to complete a second 30 minute session of cognitive testing.
- Conditions
- Arrhythmia, Atrial Fibrillation
- Being tested
- Sentinel® Cerebral Protection System, Magnetic Resonance Imaging
- Medical subject headings
- Arrhythmias, Cardiac, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel® Cerebral Protection SystemDevice
A percutaneously delivered dual-filter protection device, designed to capture and remove debris dislodged during transcatheter aortic valve replacement procedures.
Magnetic Resonance ImagingDiagnostic test
Also called MRI
Cerebral MRI will be performed without gadolinium contrast using a 3 Tesla scanner prior to and 1 to 7 days after catheter ablation
| Study group | Role | What they receive |
|---|---|---|
| Sentinel® Cerebral Protection System Group | Experimental | Sentinel® Cerebral Protection System in patients undergoing AF catheter ablation Receives: Device: Sentinel® Cerebral Protection System; Diagnostic Test: Magnetic Resonance Imaging |
| Standard of Care Group | Active comparator | Standard of care (no cerebral protection device) in patients undergoing AF catheter ablation Receives: Diagnostic Test: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident of overt and covert CNS injury 7 days post AF ablation
Incidence of overt and covert CNS injury confirmed using physical examination and / or brain imaging during or within 7 days of the AF ablation
Measured: 7 days post AF ablation
Incident of overt and covert CNS injury 90 days post AF ablation
Incidence of overt and covert CNS injury during or within 90 days of the AF ablation
Measured: 90 days post AF ablation
Secondary outcomes (2)
Change in neurocognitive function score
Montreal cognitive assessment will administered at baseline and 90 days following ablation. Change in cognitive function score will be compared between the groups. The score ranges from 0 to 30 with higher score indicating better cognitive performance.
Measured: Baseline, 90 days
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start7 Mar 2023
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized study of Sentinel cerebral protection device vs no cerebral protection device in patients undergoing atrial fibrillation ablation.
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malini Madhavan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Malini Madhavan, Mayo Clinic
- Investigators
- Malini Madhavan, MBBS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685317
- Sponsor's protocol ID
- 19-002836
- Status last verified
- Jun 2026
- First submitted
- 22 Dec 2020
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Jul 2026. 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
- ClinicalTrials.gov ID
- NCT04685317
- Acronym / sponsor ID
- 19-002836
- Conditions
- Arrhythmia, Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Malini MadhavanUniversity, hospital or other
- Study start
- 7 Mar 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 28 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.
The purpose of the study is to see if the Sentinel® Cerebral Protection System may prevent occurrence of stroke during an ablation procedure for atrial fibrillation (AF). The secondary purpose of this study is to study if cognitive function after AF ablation differs between those treated with the Sentinel cerebral protection device and those who do not receive the device.
Detailed description
If assigned to receive the device, the Sentinel® Cerebral Protection System will be placed in your heart at the beginning of your ablation procedure, and then removed along with any collected blood debris upon completion of your procedure. The study team will then call you 30 days after your procedure to assess any neurological events. Your final visit will be 90 days after your procedure to complete a second 30 minute session of cognitive testing.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized study of Sentinel cerebral protection device vs no cerebral protection device in patients undergoing atrial fibrillation ablation.
| Arm | Type | Receives |
|---|---|---|
| Sentinel® Cerebral Protection System Group | Experimental | Device: Sentinel® Cerebral Protection System, Diagnostic Test: Magnetic Resonance ImagingSentinel® Cerebral Protection System in patients undergoing AF catheter ablation |
| Standard of Care Group | Active comparator | Diagnostic Test: Magnetic Resonance ImagingStandard of care (no cerebral protection device) in patients undergoing AF catheter ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men / women over the age of 18 years undergoing radiofrequency, pulsed field or cryo-balloon ablation for AF in accordance with the current AHA/ACC/HRS guideline for management of patients with atrial fibrillation. This includes patients with symptomatic paroxysmal, persistent or long-standing persistent AF not responsive to or intolerant of a Class I or III anti-arrhythmic drug or patients with symptomatic paroxysmal or persistent AF prior to the initiation of a Class I or Class III antiarrhythmic drug). The decision to perform catheter ablation for AF will be made by the treating provider and the patient in accordance with the guidelines noted above. (January et al. J Am Coll Cardiol vol. 64, No. 21, 2014, page e1)
- Able to provide informed consent.
- Patients should have acceptable aortic arch anatomy and vessel diameters without significant stenosis as assessed using pre-procedure CT angiogram.
Key exclusion criteria (12 listed)
- Anatomy unsuitable for use of Sentinel device:
- Cerebrovascular accident or transient ischemic attack within six months
- Carotid disease requiring treatment within six weeks
- Unable or unwilling to provide informed consent.
- Pregnant women
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 |
|---|---|---|
| Sentinel® Cerebral Protection SystemA percutaneously delivered dual-filter protection device, designed to capture and remove debris dislodged during transcatheter aortic valve replacement procedures. | Device | Sentinel® Cerebral Protection System Group |
| Magnetic Resonance ImagingAlso: MRICerebral MRI will be performed without gadolinium contrast using a 3 Tesla scanner prior to and 1 to 7 days after catheter ablation | Diagnostic test | Sentinel® Cerebral Protection System Group, Standard of Care Group |
Primary outcome
Incident of overt and covert CNS injury 7 days post AF ablation
Time frame: 7 days post AF ablation
Incidence of overt and covert CNS injury confirmed using physical examination and / or brain imaging during or within 7 days of the AF ablation
Incident of overt and covert CNS injury 90 days post AF ablation
Time frame: 90 days post AF ablation
Incidence of overt and covert CNS injury during or within 90 days of the AF ablation
2 secondary outcomes
Change in neurocognitive function score
Time frame: Baseline, 90 days
New cerebral infarcts
Time frame: day 1 to 7 after atrial fibrillation ablation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Malini Madhavan, MBBS 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 Sentinel® Cerebral Protection System and Magnetic Resonance Imaging in people with Arrhythmia and Atrial Fibrillation, run by Malini Madhavan 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 3 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 21 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joseph Abdel Messih (507-422-3967, mansour.joseph@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident of overt and covert CNS injury 7 days post AF ablation (time frame: 7 days post AF ablation). 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 21 Jul 2026.