Stitch Closure of PFO and Septal Repair (STITCH)

HeartStitch.Com

Status

Unknown

Conditions

Foramen Ovale, Patent

Septal Defect, Heart

Septal Defect, Atrial

Treatments

Device: PFO Closure Rate

Device: Published PFO Device Closure

Study type

Interventional

Funder types

Industry

Identifiers

NCT03373929

17-2871

Details and patient eligibility

About

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.

Enrollment

250 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

250 participants in 2 patient groups

PFO Closure Rate

Other group

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

Treatment:

Device: Published PFO Device Closure

Device: PFO Closure Rate

Published PFO Device Closure

Other group

Description:

Compare PFO closure rate and safety of closure of septal occluders in published PFO clinical trials.

Treatment:

Device: Published PFO Device Closure

Device: PFO Closure Rate