Back to resultsStitch Closure of PFO and Septal Repair (STITCH)
Primary Purpose
Foramen Ovale, Patent, Septal Defect, Atrial, Septal Defect, Heart
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PFO Closure Rate
Published PFO Device Closure
Sponsored by
About this trial
This is an interventional treatment trial for Foramen Ovale, Patent
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients under 18 and over 65
- Patients who are not fluent in English
Sites / Locations
- Inova Cardiovascular Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
PFO Closure Rate
Published PFO Device Closure
Arm Description
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
Compare PFO closure rate and safety of closure of septal occluders in published PFO clinical trials.
Outcomes
Primary Outcome Measures
Closure Rates of PFO and ASD
Saline Contrast Echo
Secondary Outcome Measures
Recurrent Stroke Rate
Rate of which Patient Experiences Recurrent Stroke
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03373929
Brief Title
Stitch Closure of PFO and Septal Repair
Acronym
STITCH
Official Title
Suture Mediated Septal Defect Closure/Repair Evaluation of the NobleStitch EL System
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 20, 2017 (Actual)
Primary Completion Date
November 20, 2019 (Anticipated)
Study Completion Date
November 20, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
HeartStitch.Com
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief 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 embolic events in patients with cryptogenic stroke and PFO.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Foramen Ovale, Patent, Septal Defect, Atrial, Septal Defect, Heart
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Non-randomized, single-center, observational study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PFO Closure Rate
Arm Type
Other
Arm Description
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
Arm Title
Published PFO Device Closure
Arm Type
Other
Arm Description
Compare PFO closure rate and safety of closure of septal occluders in published PFO clinical trials.
Intervention Type
Device
Intervention Name(s)
PFO Closure Rate
Intervention Description
Suture Mediated PFO Closure and Septal Repair
Intervention Type
Device
Intervention Name(s)
Published PFO Device Closure
Intervention Description
Suture Mediated PFO Closure and Septal Repair
Primary Outcome Measure Information:
Title
Closure Rates of PFO and ASD
Description
Saline Contrast Echo
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Recurrent Stroke Rate
Description
Rate of which Patient Experiences Recurrent Stroke
Time Frame
4-6 weeks, 6 months, 1 year and annually up to five years
Other Pre-specified Outcome Measures:
Title
Migraine
Description
Rate of Patients who have Experienced Improvement in Migraine
Time Frame
4-6 weeks, 6 months, 1 year and annually up to five years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Patients under 18 and over 65
Patients who are not fluent in English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Thompson, MD
Organizational Affiliation
Inova Cardiovascular Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inova Cardiovascular Institute
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Stitch Closure of PFO and Septal Repair
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