Back to resultsSafety and Efficacy of the Sentinel Cerebral Protection Device in Atrial Fibrillation Ablation
Primary Purpose
Arrhythmia, Atrial Fibrillation
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sentinel® Cerebral Protection System
Magnetic Resonance Imaging
Sponsored by
About this trial
This is an interventional prevention trial for Arrhythmia
Eligibility Criteria
Inclusion Criteria:
- Men / women over the age of 18 years undergoing radiofrequency 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.
Exclusion Criteria:
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.
- 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.
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sentinel® Cerebral Protection System Group
Standard of Care Group
Arm Description
Sentinel® Cerebral Protection System in patients undergoing AF catheter ablation
Standard of care (no cerebral protection device) in patients undergoing AF catheter ablation
Outcomes
Primary Outcome Measures
Incident of stroke / TIA 7 days post AF ablation
Incidence of stroke / TIA confirmed using physical examination and / or brain imaging during or within 7 days of the AF ablation
Incident of stroke / TIA 90 days post AF ablation
Incidence of stroke / TIA during or within 90 days of the AF ablation
Secondary Outcome Measures
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04685317
Brief Title
Safety and Efficacy of the Sentinel Cerebral Protection Device in Atrial Fibrillation Ablation
Official Title
A Pilot Randomized Study of the Use of The Sentinel Device for Cerebral Protection During Atrial Fibrillation Ablation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
March 7, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Malini Madhavan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia, Atrial Fibrillation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized study of Sentinel cerebral protection device vs no cerebral protection device in patients undergoing atrial fibrillation ablation.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sentinel® Cerebral Protection System Group
Arm Type
Experimental
Arm Description
Sentinel® Cerebral Protection System in patients undergoing AF catheter ablation
Arm Title
Standard of Care Group
Arm Type
Active Comparator
Arm Description
Standard of care (no cerebral protection device) in patients undergoing AF catheter ablation
Intervention Type
Device
Intervention Name(s)
Sentinel® Cerebral Protection System
Intervention Description
A percutaneously delivered dual-filter protection device, designed to capture and remove debris dislodged during transcatheter aortic valve replacement procedures.
Intervention Type
Diagnostic Test
Intervention Name(s)
Magnetic Resonance Imaging
Other Intervention Name(s)
MRI
Intervention Description
Cerebral MRI will be performed without gadolinium contrast using a 3 Tesla scanner prior to and 1 to 7 days after catheter ablation
Primary Outcome Measure Information:
Title
Incident of stroke / TIA 7 days post AF ablation
Description
Incidence of stroke / TIA confirmed using physical examination and / or brain imaging during or within 7 days of the AF ablation
Time Frame
7 days post AF ablation
Title
Incident of stroke / TIA 90 days post AF ablation
Description
Incidence of stroke / TIA during or within 90 days of the AF ablation
Time Frame
90 days post AF ablation
Secondary Outcome Measure Information:
Title
Change in neurocognitive function score
Description
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.
Time Frame
Baseline, 90 days
Title
New cerebral infarcts
Description
Total number of new cerebral infarcts in the protected territories detected on brain MRI after ablation in the Sentinel device group vs control group
Time Frame
day 1 to 7 after atrial fibrillation ablation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Men / women over the age of 18 years undergoing radiofrequency 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.
Exclusion Criteria:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Malini Madhavan, MBBS
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Safety and Efficacy of the Sentinel Cerebral Protection Device in Atrial Fibrillation Ablation
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