Sentinel Cerebral Protection System for Atrial Fibrillation

Recruiting in Palo Alto (17 mi)

Overseen by Malini Madhavan, MBBS

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Malini Madhavan

Disqualifiers: Dementia, Pregnancy, Left atrial thrombus, others

No Placebo Group

Approved in 1 Jurisdiction

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.

Trial 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 (Cerebral Protection Device)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mayo Clinic in Rochester Rochester, MN

Who Is Running the Clinical Trial?

Malini Madhavan

Lead Sponsor

Trials

1

Patients Recruited

50+

Findings from Research

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

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]

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]