Sentinel Cerebral Protection System for Atrial Fibrillation

Overseen By Grace Purkey

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Malini Madhavan

Disqualifiers: Dementia, Pregnancy, Left atrial thrombus, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether the Sentinel® Cerebral Protection System can prevent strokes during an ablation procedure for atrial fibrillation (irregular heartbeat). It also seeks to determine if using this device affects thinking skills after the procedure compared to not using it. The trial includes two groups: one will use the Sentinel device, and the other will follow the standard procedure without it. Individuals with atrial fibrillation who plan to undergo ablation, especially if medication hasn't worked, might be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative solutions for stroke prevention and cognitive health during ablation procedures.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that patients with atrial fibrillation not responsive to or intolerant of certain anti-arrhythmic drugs are included, which might imply some flexibility with current medications.

What prior data suggests that the Sentinel Cerebral Protection System is safe for preventing stroke during AF ablation?

Research has shown that the Sentinel® Cerebral Protection System is safe for people, with studies indicating a very low rate of complications during use. Specifically, the device was successfully used 94.4% of the time, and only 0.1% of patients experienced blood vessel issues. This indicates it is well-tolerated. Additionally, the system is linked to a lower risk of stroke and serious bleeding in patients undergoing heart procedures. This safety record suggests it could be a reliable option for reducing stroke risk during heart treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Sentinel® Cerebral Protection System is unique because it offers a specialized approach to reduce the risk of stroke during AF catheter ablation procedures. Unlike the standard of care, which generally involves catheter ablation without any cerebral protection, this system uses a novel mechanism that filters out harmful debris from entering the brain's blood supply. Researchers are excited about this treatment because it has the potential to enhance patient safety by providing an extra layer of protection against strokes, a serious risk associated with the procedure.

What evidence suggests that the Sentinel Cerebral Protection System is effective for preventing stroke during AF ablation?

Research shows that the Sentinel Cerebral Protection System can reduce the risk of strokes during certain heart procedures. In studies of a similar procedure called TAVR, a type of heart valve replacement, the Sentinel device led to a 21% decrease in all strokes and a 60% decrease in serious strokes within 72 hours. In this trial, participants in the Sentinel® Cerebral Protection System Group will receive this device during ablation for atrial fibrillation (AF), a common heart rhythm problem. The system catches debris that could otherwise travel to the brain and cause a stroke. Evidence supports its potential to make these procedures safer by lowering the risk of stroke. ^{1 2 3 5 6}

Who Is on the Research Team?

Malini Madhavan, MBBS

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for men and women over 18 with atrial fibrillation not well-managed by drugs, who can consent and have suitable aortic arch anatomy. It's not for those with certain vascular issues, dementia, pregnancy, MRI non-compatible devices in their body, recent strokes or transient ischemic attacks, hypersensitivity to nickel-titanium or reversible AF causes like hyperthyroidism.

Inclusion Criteria

My heart's main artery and its branches are the right size and not significantly narrowed.

Able to provide informed consent

My AFib symptoms persist despite trying specific heart rhythm medications.

Exclusion Criteria

I need treatment for my carotid artery within six weeks.

My major neck or chest arteries are not suitable for the procedure due to their shape or condition.

My right arm's blood flow is not suitable for the Sentinel device.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo AF catheter ablation with or without the Sentinel® Cerebral Protection System

1 day

1 visit (in-person)

Follow-up

Participants are monitored for neurological events and cognitive function post-ablation

90 days

1 call (30 days post-procedure), 1 visit (90 days post-procedure)

What Are the Treatments Tested in This Trial?

Interventions

• Sentinel® Cerebral Protection System

Trial Overview The study tests if the Sentinel® Cerebral Protection System can prevent strokes during ablation procedures for atrial fibrillation. Participants will either receive this device or not as part of their treatment to compare outcomes including cognitive function post-procedure.

How Is the Trial Designed?

Group I: Sentinel® Cerebral Protection System Group Experimental Treatment 2 Interventions

Sentinel® Cerebral Protection System in patients undergoing AF catheter ablation

Group II: Standard of Care Group Active Control 1 Intervention

Standard of care (no cerebral protection device) in patients undergoing AF catheter ablation

Sentinel® Cerebral Protection System is already approved in United States for the following indications:

Approved in United States as Sentinel Cerebral Protection System for:

• Cerebral protection during transcatheter aortic valve replacement (TAVR) procedures

Who Is Running the Clinical Trial?

Malini Madhavan

Lead Sponsor

Trials

1

Recruited

50+

Published Research Related to This Trial

Implantable atrial defibrillators can effectively achieve atrial defibrillation with low energy levels (typically < 2 J), using large surface area catheters in the right atrium and coronary sinus, which minimizes damage to heart tissue.

Preliminary findings indicate that shocks synchronized to R waves are safe and well tolerated at energies below 1.5 J, suggesting that with further research, this therapy could be a viable option for patients with symptomatic atrial fibrillation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implantable atrial defibrillators. Hillsley, RE., Wharton, JM.[2019]

In a study conducted at six pharmacies, smartphone-based ECG devices identified atrial fibrillation (AF) in 3.60% of participants, with 1.92% having previously unknown AF, highlighting the potential for early detection in older adults.

The Kardia Mobile app demonstrated higher sensitivity (66.7%) and specificity (98.5%) for detecting AF compared to the Veroval device, suggesting it may be a more effective tool for opportunistic screening in pharmacies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The comparison of Kardia Mobile and Hartmann Veroval 2 in 1 in detecting first diagnosed atrial fibrillation. Zaprutko, T., Zaprutko, J., Sprawka, J., et al.[2023]

A large-scale smartphone-based screening for atrial fibrillation (AF) was feasible, detecting AF in 1.3% of the 60,629 participants, leading to significant therapy adjustments for newly diagnosed cases.

The screening increased the uptake of oral anti-coagulation therapy from 56% to 74% in patients with clinical AF, demonstrating its potential to improve treatment outcomes, although it had limited impact on risk factor management in those with subclinical AF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-based atrial fibrillation screening in the general population: feasibility and impact on medical treatment. Gruwez, H., Verbrugge, FH., Proesmans, T., et al.[2023]

A digital atrial fibrillation (AF) screening program using a smartphone app was feasible for elderly participants, with 79% of the 204 registered individuals meeting the target of two sufficient recordings per day.

The program successfully identified potential AF cases, with 3 confirmed diagnoses out of 12 suspected cases, although only 5 out of 12 participants followed through to see a cardiologist, indicating challenges in participant follow-up despite the program's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of digital atrial fibrillation screening in an elderly population : The Ulm heart rhythm weeks. Birkemeyer, R., Maisch, L., Dahme, T., et al.[2022]

The RITMIA™ app, combined with a consumer-grade Bluetooth heart rate monitor, demonstrated a high accuracy in detecting atrial fibrillation (AF) with 97% sensitivity and 95.6% specificity when compared to standard 12-lead ECGs in a study of 95 patients.

This technology is promising for widespread AF screening due to its affordability and ability to provide long-term monitoring, making it suitable for identifying patients at risk for silent AF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The RITMIA™ Smartphone App for Automated Detection of Atrial Fibrillation: Accuracy in Consecutive Patients Undergoing Elective Electrical Cardioversion. Reverberi, C., Rabia, G., De Rosa, F., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11262339/

Patient Characteristics and Outcomes Associated with ... The Sentinel Cerebral Protection System (CPS) was developed to reduce the risk of embolic strokes associated with debris produced during TAVR. Studies ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155383891930257X

Clinical Outcomes of Sentinel Cerebral Protection System ... The results suggest that Sentinel CPS use in TAVR is associated with a lower risk of stroke, mortality and major or life-threatening bleeding at 30 days.

3. bostonscientific.com bostonscientific.com/us/en/healthcare-professionals/products/cerebral-protection-systems/sentinel-cerebral-protection-system/fp90000121.html

SENTINEL™ Cerebral Protection System Data showed a 21% relative risk reduction in all stroke and a 60% significant relative risk reduction in disabling stroke through 72-hours. alt text ...

4. fda.gov fda.gov/media/102984/download

Sentinel® Cerebral Protection System The average STS score was 6.7 ± 3.79, 31.7% of patients had a history of atrial fibrillation, 83.1% of patients had NYHA classification of Class 3 and above, ...

5. thecardiologyadvisor.com thecardiologyadvisor.com/news/sentinel-cerebral-protection-system-use-in-tavr-associated-with-lower-incidence-of-ischemic-stroke/

Outcomes With Use of Sentinel Cerebral Protection System ... Overall, the percentage of ischemic strokes was 2.4% and the percentage of hemorrhagic strokes was 0.2%. After propensity score matching, the ...

6. bostonscientific.com bostonscientific.com/en-EU/medical-specialties/structural-heart/sentinel-cerebral-protection-system/clinical-data.html

Clinical data / Sentinel The SENTINEL CPS demonstrated excellent safety profile with high rates of device delivery/retrieval (94.4%) and very low rates of vascular complications (0.1%).