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Patent Foramen Ovale (PFO) Closure at the Time of Endovascular Cardiac Electronic Device Implantation (PFOCUS)

Primary Purpose

Foramen Ovale, Patent

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aspirin
Cardiovascular Implantable Device (CIED)
Gore Cardioform Septal Occluder
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Foramen Ovale, Patent

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A clinical indication for a transvenous pacemaker or defibrillator implantation,
  • Must have a documented PFO determined from Transthoracic Echocardiogram (TTE) echocardiographic agitated saline contrast study that is determined to be feasible for transcatheter closure.
  • The GORE® CARDIOFORM Septal Occluder should only be used in subjects whose vasculature is adequate to accommodate a 10 Fr delivery sheath (or 12 Fr delivery sheath when a guidewire is used).
  • All subjects must be able to undergo standardized neurocognitive testing, and dementia/mental status examination screening.

Exclusion Criteria:

  • Subjects with a survival expectancy of less than one year.
  • Subjects with an atrial septal defect or shunt that clinically requires closure for hemodynamic or other purposes.
  • Absence of a clinical indication for a transvenous CIED system.
  • Subjects with any clinical indication mandating anticoagulation.
  • Subjects with previously placed CIED devices will be excluded.
  • Unable to take anti-platelet medications such as aspirin or clopidogrel (Plavix).
  • With anatomy where the GORE® CARDIOFORM Septal Occluder size or position would interfere with other intracardiac or intravascular structures, such as cardiac valves or pulmonary veins.
  • With active endocarditis, or other infections producing bacteremia, or with known sepsis within one month of planned implantation, or any other infection that cannot be treated successfully prior to device placement.
  • With known intracardiac thrombi.
  • Known pregnancy at the time of automated implantable cardioverter-defibrillator (AICD) implant

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

PFO Closure

Control

Arm Description

Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED), Gore Cardioform Septal Occluder.

Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED)

Outcomes

Primary Outcome Measures

Number of Embolic Brain Lesions Detected on MRI >3 mm
The mean number of embolic brain lesions will be calculated at approximately 1 year.

Secondary Outcome Measures

Number of Subjects Who Die
The mean number of deaths will be calculated at approximately 1 year.
Number of Subjects Who Experience a Stroke
Stroke is defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.
Number of Subjects who Experience a Transient Ischemic Attack (TIA)
Transient ischemic attack (TIA) is defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction.
Change in Executive Function as Measured by Trail Making Test B
Trail Making Test B consists of 25 circles including both numbers (1-13) and letters (A-L). The subject draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters. The subject is timed as they draw the trail. Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. The average score is 75 seconds; > 273 seconds is considered deficient. Trail Making Test B consists of 25 circles including both numbers (1 - 13) and letters (A - L). The subject draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters. The subject is timed as they draw the trail. Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. The average score is 75 seconds; > 273 seconds is considered deficient.
Change in Language as Measured by Letter and Category Fluency Test
The examiner gives the subject a category and ask them to name all the different examples that they can think of from that category in one minute. Examples of categories are animals, fruit, birds, breeds of dog, tools, etc. Subjects are also asked to provide examples that start with a given letter. To score, the examiner counts the number of unique responses for a category or letter for one minute; categories can be averaged together. The higher the score the better the language fluency, the lower the score, the worse the language fluency.
Change in Psychomotor Speed as Measured by Trail Making A Test
Trail Making Test A consists of 25 numbered circles distributed over a sheet of paper. The patient should draw lines to connect the numbers in ascending order. The patient is timed as they draw the trail. Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. The average score is 29 seconds; > 78 seconds is considered deficient.

Full Information

First Posted
July 20, 2017
Last Updated
March 11, 2020
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT03232450
Brief Title
Patent Foramen Ovale (PFO) Closure at the Time of Endovascular Cardiac Electronic Device Implantation
Acronym
PFOCUS
Official Title
PFOCUS Pilot Trial- A Prospective Pilot Trial for PFO ClosUre at the Time of endovaScular Cardiac Electronic Device Implantation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Withdrawn
Why Stopped
No funding or enrollment
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Participants enrolled in this study will have been diagnosed with patent foramen ovale (PFO) and have been scheduled to have a cardiovascular implantable electronic device (CIED) such as a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT) device implanted. A PFO is a condition when there is a hole in the septum (the wall separating the right and left sides) of the heart. The purpose of this study is to determine whether closing the PFO with the GORE® Cardioform Septal Occluder in people with an endocardial device leads reduces the risk of recurrent stroke or imaging-confirmed transient ischemic attack (TIA) compared to not closing the PFO.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foramen Ovale, Patent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PFO Closure
Arm Type
Active Comparator
Arm Description
Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED), Gore Cardioform Septal Occluder.
Arm Title
Control
Arm Type
Other
Arm Description
Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED)
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Acetylsalicylic acid (ASA)
Intervention Description
Subjects will receive 81 mg enteric coated aspirin
Intervention Type
Device
Intervention Name(s)
Cardiovascular Implantable Device (CIED)
Intervention Description
All subjects will receive either a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT).
Intervention Type
Device
Intervention Name(s)
Gore Cardioform Septal Occluder
Intervention Description
The Gore Cardioform Septal Occluder closes the patent foramen ovale (PFO).
Primary Outcome Measure Information:
Title
Number of Embolic Brain Lesions Detected on MRI >3 mm
Description
The mean number of embolic brain lesions will be calculated at approximately 1 year.
Time Frame
1 year post implantation
Secondary Outcome Measure Information:
Title
Number of Subjects Who Die
Description
The mean number of deaths will be calculated at approximately 1 year.
Time Frame
1 year post implantation
Title
Number of Subjects Who Experience a Stroke
Description
Stroke is defined as an acute episode of focal or global neurological dysfunction caused by brain, spinal cord, or retinal vascular injury as a result of hemorrhage or infarction.
Time Frame
1 year post implantation
Title
Number of Subjects who Experience a Transient Ischemic Attack (TIA)
Description
Transient ischemic attack (TIA) is defined as a transient episode of focal neurological dysfunction caused by brain, spinal cord, or retinal ischemia, without acute infarction.
Time Frame
1 year post implantation
Title
Change in Executive Function as Measured by Trail Making Test B
Description
Trail Making Test B consists of 25 circles including both numbers (1-13) and letters (A-L). The subject draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters. The subject is timed as they draw the trail. Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. The average score is 75 seconds; > 273 seconds is considered deficient. Trail Making Test B consists of 25 circles including both numbers (1 - 13) and letters (A - L). The subject draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters. The subject is timed as they draw the trail. Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. The average score is 75 seconds; > 273 seconds is considered deficient.
Time Frame
baseline, 1 year post implantation
Title
Change in Language as Measured by Letter and Category Fluency Test
Description
The examiner gives the subject a category and ask them to name all the different examples that they can think of from that category in one minute. Examples of categories are animals, fruit, birds, breeds of dog, tools, etc. Subjects are also asked to provide examples that start with a given letter. To score, the examiner counts the number of unique responses for a category or letter for one minute; categories can be averaged together. The higher the score the better the language fluency, the lower the score, the worse the language fluency.
Time Frame
baseline, 1 year post implantation
Title
Change in Psychomotor Speed as Measured by Trail Making A Test
Description
Trail Making Test A consists of 25 numbered circles distributed over a sheet of paper. The patient should draw lines to connect the numbers in ascending order. The patient is timed as they draw the trail. Results are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. The average score is 29 seconds; > 78 seconds is considered deficient.
Time Frame
baseline, 1 year post implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A clinical indication for a transvenous pacemaker or defibrillator implantation, Must have a documented PFO determined from Transthoracic Echocardiogram (TTE) echocardiographic agitated saline contrast study that is determined to be feasible for transcatheter closure. The GORE® CARDIOFORM Septal Occluder should only be used in subjects whose vasculature is adequate to accommodate a 10 Fr delivery sheath (or 12 Fr delivery sheath when a guidewire is used). All subjects must be able to undergo standardized neurocognitive testing, and dementia/mental status examination screening. Exclusion Criteria: Subjects with a survival expectancy of less than one year. Subjects with an atrial septal defect or shunt that clinically requires closure for hemodynamic or other purposes. Absence of a clinical indication for a transvenous CIED system. Subjects with any clinical indication mandating anticoagulation. Subjects with previously placed CIED devices will be excluded. Unable to take anti-platelet medications such as aspirin or clopidogrel (Plavix). With anatomy where the GORE® CARDIOFORM Septal Occluder size or position would interfere with other intracardiac or intravascular structures, such as cardiac valves or pulmonary veins. With active endocarditis, or other infections producing bacteremia, or with known sepsis within one month of planned implantation, or any other infection that cannot be treated successfully prior to device placement. With known intracardiac thrombi. Known pregnancy at the time of automated implantable cardioverter-defibrillator (AICD) implant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel J Asirvatham
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

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Patent Foramen Ovale (PFO) Closure at the Time of Endovascular Cardiac Electronic Device Implantation

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