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NCT03373929 Clinical Trial

Stitch Closure of PFO and Septal Repair

Foramen Ovale, Patent Clinical Trial

— STITCH  

Official title:
Suture Mediated Septal Defect Closure/Repair Evaluation of the NobleStitch EL System

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT03373929
Other study ID # 17-2871
Secondary ID
Status Enrolling by invitation
Phase N/A
First received December 6, 2017
Last updated December 11, 2017
Start date November 20, 2017
Est. completion date November 20, 2022

Study information
Verified date December 2017
Source HeartStitch.Com
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 embolic events in patients with cryptogenic stroke and PFO.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 250
Est. completion date November 20, 2022
Est. primary completion date November 20, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Inova Cardiovascular Institute Falls Church Virginia

Sponsors (1)
Lead Sponsor Collaborator
HeartStitch.Com

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Other Migraine Rate of Patients who have Experienced Improvement in Migraine 4-6 weeks, 6 months, 1 year and annually up to five years
Primary Closure Rates of PFO and ASD Saline Contrast Echo 12 months
Secondary Recurrent Stroke Rate Rate of which Patient Experiences Recurrent Stroke 4-6 weeks, 6 months, 1 year and annually up to five years
See also
  Status Clinical Trial Phase
Completed NCT00196040 - The Paradigm II Trial: PFX Closure System in Subjects With Cryptogenic Stroke, Transient Ischemic Attack, Migraine or Decompression Illness N/A
Recruiting NCT01934725 - Searching for Explanations for Cryptogenic Stroke in the Young: Revealing the Etiology, Triggers, and Outcome
Completed NCT02432131 - Decompression Sickness in Divers With or Without Patent Foramen Ovale
Recruiting NCT04987008 - Risk of Ischaemic Stroke After Pulmonary Embolism in Patients With and Without Patent Foramen Ovale
Recruiting NCT04881578 - Atrial Fibrillation Before and After Patent Foramen Ovale Closure Study
Completed NCT02400892 - Patent Foramen Ovale and the Risk of Postoperative Delirium Following Elective Hip and Knee Arthroplasty Surgeries N/A
Recruiting NCT01385670 - InterSEPT: In‐Tunnel SeptRx European PFO Trial N/A
Completed NCT02957201 - The Effect on EPCs by Successful Cardiac Occlusion Device Implantation N/A
Completed NCT00968032 - Procedural Success and Safety of the Nit-Occlud® Patent Foramen Ovale (PFO) Closure Device and Its Application System N/A
Recruiting NCT05558774 - Long-term Outcomes After Percutaneous Closure of PFO
Completed NCT02127294 - Effectiveness and Safety of Transcatheter Patent Foramen Ovale Closure for Migraine N/A
Recruiting NCT01149447 - Prospective Clinical Follow-up After the Percutaneous Closure of a Patent Foramen Ovale N/A
Enrolling by invitation NCT05025475 - Stitch Closure of PFO and Septal Repair (STITCH) N/A
Suspended NCT04339699 - NobleStitch EL STITCH Trial is a PFO Comparative Trial N/A
Recruiting NCT04713683 - Investigation of Nickel Sensitization After Percutaneous Implantation of Patent Foramen Ovale Occluder N/A
Withdrawn NCT03232450 - Patent Foramen Ovale (PFO) Closure at the Time of Endovascular Cardiac Electronic Device Implantation N/A