Stitch Closure of PFO and Septal Repair

HeartStitch.Com250 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

250

Conditions

Foramen Ovale, Patent Septal Defect, Atrial Septal Defect, Heart

Interventions

PFO Closure RateDEVICE

Suture Mediated PFO Closure and Septal Repair

Published PFO Device ClosureDEVICE

Suture Mediated PFO Closure and Septal Repair

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Inova Cardiovascular Institute

Falls Church, Virginia, United States

Outcomes

Primary Outcomes

Closure Rates of PFO and ASD

Saline Contrast Echo

Time frame: 12 months

Secondary Outcomes

Recurrent Stroke Rate

Rate of which Patient Experiences Recurrent Stroke

Time frame: 4-6 weeks, 6 months, 1 year and annually up to five years

Data from ClinicalTrials.gov

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