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Stitch Closure of PFO and Septal Repair (STITCH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03373929
Recruitment Status : Unknown
Verified December 2017 by James Thompson, MD, HeartStitch.Com.
Recruitment status was:  Enrolling by invitation
First Posted : December 14, 2017
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
James Thompson, MD, HeartStitch.Com

Study Description
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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.

Condition or disease Intervention/treatment Phase
Foramen Ovale, Patent Septal Defect, Atrial Septal Defect, Heart Device: PFO Closure Rate Device: Published PFO Device Closure Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Non-randomized, single-center, observational study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Suture Mediated Septal Defect Closure/Repair Evaluation of the NobleStitch EL System
Actual Study Start Date : November 20, 2017
Estimated Primary Completion Date : November 20, 2019
Estimated Study Completion Date : November 20, 2022
Arms and Interventions
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Arm Intervention/treatment
PFO Closure Rate
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
 Device: PFO Closure Rate
Suture Mediated PFO Closure and Septal Repair

Device: Published PFO Device Closure
Suture Mediated PFO Closure and Septal Repair
Published PFO Device Closure
Compare PFO closure rate and safety of closure of septal occluders in published PFO clinical trials.
 Device: PFO Closure Rate
Suture Mediated PFO Closure and Septal Repair

Device: Published PFO Device Closure
Suture Mediated PFO Closure and Septal Repair


Outcome Measures
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Primary Outcome Measures :
  1. Closure Rates of PFO and ASD [ Time Frame: 12 months ]
    Saline Contrast Echo


Secondary Outcome Measures :
  1. Recurrent Stroke Rate [ Time Frame: 4-6 weeks, 6 months, 1 year and annually up to five years ]
    Rate of which Patient Experiences Recurrent Stroke


Other Outcome Measures:
  1. Migraine [ Time Frame: 4-6 weeks, 6 months, 1 year and annually up to five years ]
    Rate of Patients who have Experienced Improvement in Migraine


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373929


Locations
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United States, Virginia
Inova Cardiovascular Institute
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
HeartStitch.Com
Investigators
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Principal Investigator: James Thompson, MD Inova Cardiovascular Institute
More Information
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Responsible Party: James Thompson, MD, Interventional Cardiologist, HeartStitch.Com
ClinicalTrials.gov Identifier: NCT03373929    
Other Study ID Numbers: 17-2871
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017

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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
Additional relevant MeSH terms:
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Heart Septal Defects
Heart Septal Defects, Atrial
Foramen Ovale, Patent
Heart Defects, Congenital
 Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities