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

Trial Summary

What is the purpose of this trial?

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.

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.

How is the Sentinel Cerebral Protection System treatment different from other treatments for atrial fibrillation?

The Sentinel Cerebral Protection System is unique because it is designed to protect the brain from potential stroke-causing debris during procedures to treat atrial fibrillation, unlike other treatments that focus on managing heart rhythm or rate. ^{1 2 3 4 5}

Research Team

Malini Madhavan, MBBS

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

I am over 18 and will have a procedure for AF as per guidelines.

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

Able to provide informed consent

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

The RITMIA™ Smartphone App for Automated Detection of Atrial Fibrillation: Accuracy in Consecutive Patients Undergoing Elective Electrical Cardioversion. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Implantable atrial defibrillators. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Smartphone-based atrial fibrillation screening in the general population: feasibility and impact on medical treatment. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Feasibility of digital atrial fibrillation screening in an elderly population : The Ulm heart rhythm weeks. [2022]

5. Poland pubmed.ncbi.nlm.nih.gov

The comparison of Kardia Mobile and Hartmann Veroval 2 in 1 in detecting first diagnosed atrial fibrillation. [2023]