Foramen Ovale, PatentPFOCUSNCT03232450
Patent Foramen Ovale (PFO) Closure at the Time of Endovascular Cardiac Electronic Device Implantation
A study testing Aspirin, Cardiovascular Implantable Device (CIED) and Gore Cardioform Septal Occluder in people with Foramen Ovale, Patent, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Foramen Ovale, Patent
- What is being tested?
- Aspirin, Cardiovascular Implantable Device (CIED) and Gore Cardioform Septal Occluder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2019to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: PFOCUS Pilot Trial- A Prospective Pilot Trial for PFO ClosUre at the Time of endovaScular Cardiac Electronic Device Implantation
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.
- Conditions
- Foramen Ovale, Patent
- Being tested
- Aspirin, Cardiovascular Implantable Device (CIED), Gore Cardioform Septal Occluder
- Medical subject headings
- Foramen Ovale, Patent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called Acetylsalicylic acid (ASA)
Subjects will receive 81 mg enteric coated aspirin
Cardiovascular Implantable Device (CIED)Device
All subjects will receive either a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT).
Gore Cardioform Septal OccluderDevice
The Gore Cardioform Septal Occluder closes the patent foramen ovale (PFO).
| Study group | Role | What they receive |
|---|---|---|
| PFO Closure | Active comparator | Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED), Gore Cardioform Septal Occluder. Receives: Drug: Aspirin; Device: Cardiovascular Implantable Device (CIED); Device: Gore Cardioform Septal Occluder |
| Control | Other | Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED) Receives: Drug: Aspirin; Device: Cardiovascular Implantable Device (CIED) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Embolic Brain Lesions Detected on MRI >3 mm
The mean number of embolic brain lesions will be calculated at approximately 1 year.
Measured: 1 year post implantation
Secondary outcomes (6)
Number of Subjects Who Die
The mean number of deaths will be calculated at approximately 1 year.
Measured: 1 year post implantation
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.
Measured: 1 year post implantation
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.
Measured: 1 year post implantation
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.
Measured: baseline, 1 year post implantation
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.
Measured: baseline, 1 year post implantation
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.
Measured: baseline, 1 year post implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study startAug 2019 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: No funding or enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foramen Ovale, PatentStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel J. Asirvatham, Mayo Clinic
- Investigators
- Samuel J Asirvatham, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232450
- Sponsor's protocol ID
- 14-005348
- Acronym
- PFOCUS
- Status last verified
- Mar 2020
- First submitted
- 20 Jul 2017
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PFOCUS Pilot Trial- A Prospective Pilot Trial for PFO ClosUre at the Time of endovaScular Cardiac Electronic Device Implantation
- ClinicalTrials.gov ID
- NCT03232450
- Acronym / sponsor ID
- PFOCUS / 14-005348
- Conditions
- Foramen Ovale, Patent
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding or enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFO Closure | Active comparator | Drug: Aspirin, Device: Cardiovascular Implantable Device (CIED), Device: Gore Cardioform Septal OccluderSubjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED), Gore Cardioform Septal Occluder. |
| Control | Other | Drug: Aspirin, Device: Cardiovascular Implantable Device (CIED)Subjects randomized to this arm will receive 81 mg enteric coated aspirin, a Cardiovascular Implantable Device (CIED) |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AspirinAlso: Acetylsalicylic acid (ASA)Subjects will receive 81 mg enteric coated aspirin | Drug | Control, PFO Closure |
| Cardiovascular Implantable Device (CIED)All subjects will receive either a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT). | Device | Control, PFO Closure |
| Gore Cardioform Septal OccluderThe Gore Cardioform Septal Occluder closes the patent foramen ovale (PFO). | Device | PFO Closure |
Primary outcome
Number of Embolic Brain Lesions Detected on MRI >3 mm
Time frame: 1 year post implantation
The mean number of embolic brain lesions will be calculated at approximately 1 year.
6 secondary outcomes
Number of Subjects Who Die
Time frame: 1 year post implantation
Number of Subjects Who Experience a Stroke
Time frame: 1 year post implantation
Number of Subjects who Experience a Transient Ischemic Attack (TIA)
Time frame: 1 year post implantation
Change in Executive Function as Measured by Trail Making Test B
Time frame: baseline, 1 year post implantation
Change in Language as Measured by Letter and Category Fluency Test
Time frame: baseline, 1 year post implantation
Change in Psychomotor Speed as Measured by Trail Making A Test
Time frame: baseline, 1 year post implantation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel J Asirvatham principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aspirin, Cardiovascular Implantable Device (CIED) and Gore Cardioform Septal Occluder in people with Foramen Ovale, Patent, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Embolic Brain Lesions Detected on MRI >3 mm (time frame: 1 year post implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.