Foramen Ovale, PatentSTITCHNCT03373929
Stitch Closure of PFO and Septal Repair
A study testing PFO Closure Rate and Published PFO Device Closure in people with Foramen Ovale, Patent and Septal Defect, Atrial, run by HeartStitch.Com at 1 site in United States.
Trial summary
The purpose of the STITCH study is to evaluate closure rates of clinically relevant septal defects, including patent foramen ovale (PFO), Atrial Septal Defects (ASD - less than 1 cm with redundant septal tissue), trans septal puncture sites, repair of Atrial Septal Aneurysm (ASA) and rate of recurrent neurologic… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Foramen Ovale, Patent, Septal Defect, Atrial, Septal Defect, Heart
- What is being tested?
- PFO Closure Rate and Published PFO Device Closure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2017to 20 Nov 2022
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PFO
- ASD (less than 1 cm with redundant septal tissue)
- Trans Septal Puncture Sites
- ASA (when an appropriate PFO or small ASD defect is present)
- Stroke
- Trans ischemic Attack (TIA)
- Platypnea Orthodeoxia Syndrome
- Decompression Illness
Who cannot join
- Patients under 18 and over 65
- Patients who are not fluent in English
Trial locations and contacts
1 site in 1 country.
United States1 site
Inova Cardiovascular Institute
Falls Church, Virginia, 22042
About this study
Official title: Suture Mediated Septal Defect Closure/Repair Evaluation of the NobleStitch EL System
The purpose of the STITCH study is to evaluate closure rates of clinically relevant septal defects, including patent foramen ovale (PFO), Atrial Septal Defects (ASD - less than 1 cm with redundant septal tissue), trans septal puncture sites, repair of Atrial Septal Aneurysm (ASA) and rate of recurrent neurologic embolic events in patients with cryptogenic stroke and PFO.
- Being tested
- PFO Closure Rate, Published PFO Device Closure
- Medical subject headings
- Foramen Ovale, Patent, Heart Septal Defects, Atrial, Heart Septal Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFO Closure RateDevice
Suture Mediated PFO Closure and Septal Repair
Published PFO Device ClosureDevice
Suture Mediated PFO Closure and Septal Repair
| Study group | Role | What they receive |
|---|---|---|
| PFO Closure Rate | Other | Evaluate closure rate of clinically relevant septal defects including PFO, ASD (less than 1 cm with redundant septal tissue), trans septal puncture sites, repair of ASA (when an appropriate PFO or small ASD defect is present) and rate of recurrent neurologic embolic event in patients with cryptogenic stroke and PFO Receives: Device: PFO Closure Rate; Device: Published PFO Device Closure |
| Published PFO Device Closure | Other | Compare PFO closure rate and safety of closure of septal occluders in published PFO clinical trials. Receives: Device: PFO Closure Rate; Device: Published PFO Device Closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Closure Rates of PFO and ASD
Saline Contrast Echo
Measured: 12 months
Secondary outcomes (1)
Recurrent Stroke Rate
Rate of which Patient Experiences Recurrent Stroke
Measured: 4-6 weeks, 6 months, 1 year and annually up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start20 Nov 2017
- Primary completion20 Nov 2019 (estimated)
- Study completion20 Nov 2022 (estimated)
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.
- 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
- Non-randomised
- Intervention model
- Single group
- Model description
- Non-randomized, single-center, observational study
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HeartStitch.Com
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, James Thompson, MD, HeartStitch.Com
- Investigators
- James Thompson, MD, Principal investigator, Inova Cardiovascular Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373929
- Sponsor's protocol ID
- 17-2871
- Acronym
- STITCH
- Status last verified
- Dec 2017
- First submitted
- 6 Dec 2017
- Last updated
- 14 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suture Mediated Septal Defect Closure/Repair Evaluation of the NobleStitch EL System
- ClinicalTrials.gov ID
- NCT03373929
- Acronym / sponsor ID
- STITCH / 17-2871
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- HeartStitch.ComIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 20 Nov 2019 (estimated)
- Study completion
- 20 Nov 2022 (estimated)
- First posted
- 14 Dec 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.
The purpose of the STITCH study is to evaluate closure rates of clinically relevant septal defects, including patent foramen ovale (PFO), Atrial Septal Defects (ASD - less than 1 cm with redundant septal tissue), trans septal puncture sites, repair of Atrial Septal Aneurysm (ASA) and rate of recurrent neurologic embolic events in patients with cryptogenic stroke and PFO.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomized, single-center, observational study
| Arm | Type | Receives |
|---|---|---|
| PFO Closure Rate | Other | Device: PFO Closure Rate, Device: Published PFO Device ClosureEvaluate closure rate of clinically relevant septal defects including PFO, ASD (less than 1 cm with redundant septal tissue), trans septal puncture sites, repair of ASA (when an appropriate PFO or small ASD defect is present) and rate of recurrent neurologic embolic event in patients with cryptogenic stroke and PFO |
| Published PFO Device Closure | Other | Device: PFO Closure Rate, Device: Published PFO Device ClosureCompare PFO closure rate and safety of closure of septal occluders in published PFO clinical trials. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- PFO
- ASD (less than 1 cm with redundant septal tissue)
- Trans Septal Puncture Sites
- ASA (when an appropriate PFO or small ASD defect is present)
- Stroke
Key exclusion criteria (2 listed)
- Patients under 18 and over 65
- Patients who are not fluent in English
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 |
|---|---|---|
| PFO Closure RateSuture Mediated PFO Closure and Septal Repair | Device | PFO Closure Rate, Published PFO Device Closure |
| Published PFO Device ClosureSuture Mediated PFO Closure and Septal Repair | Device | PFO Closure Rate, Published PFO Device Closure |
Primary outcome
Closure Rates of PFO and ASD
Time frame: 12 months
Saline Contrast Echo
1 secondary outcome
Recurrent Stroke Rate
Time frame: 4-6 weeks, 6 months, 1 year and annually up to five years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2017.
Related trials for Foramen Ovale, Patent
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Recruiting
Discontinuation of Antithrombotic Treatment Following Patent Foramen Ovale Closure in Young Patients With Cryptogenic Stroke
Patent Foramen Ovale, Ischemic Stroke
Active, not recruiting
Comparing PFO Outcomes of the Occlutech Flex II PFO Occluder to Standard of Care PFO Occlusion
Stroke, Patent Foramen Ovale
RecruitingPhase 3
Migraine Headaches Elimination With Patent Foramen Ovale-Directed Therapy
Migraine Disease, Patent Foramen Ovale
Recruiting
Comparing Two PFO Closure Devices in Adults With Previous Stroke or TIA
Patent Foramen Ovale, Stroke
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.
James Thompson, MD principal investigator
Inova Cardiovascular Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PFO Closure Rate and Published PFO Device Closure in people with Foramen Ovale, Patent and Septal Defect, Atrial, run by HeartStitch.Com 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 8 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Dec 2017. 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?
Results are not available in the source record.
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?
Closure Rates of PFO and ASD (time frame: 12 months). 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 14 Dec 2017.