## Protocol Section
### Identification Module
**NCT ID:** NCT06413147

**Brief Title:** Long-term Procedural and Device Related Complications of PFO Closure

**Official Title:** Long-term Procedural and Device Related Complications of PFO Closure

#### Organization Study ID Info
**ID:** yinchunlin_PFO safety
#### Organization
**Class:** OTHER
**Full Name:** Xuanwu Hospital, Beijing
### Status Module
#### Completion Date
**Date:** 2029-05-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-13

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2029-05-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-30

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-08
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Xuanwu Hospital, Beijing

#### Responsible Party

**Investigator Affiliation:** Xuanwu Hospital, Beijing

**Investigator Full Name:** yinchunlin

**Investigator Title:** Xuanwu Hospital, Capital Medical University

**Type:** PRINCIPAL_INVESTIGATOR

### Description Module

**Brief Summary:** We aimed to explore: (1）long-term complications of PFO closure; (2) antiplate or anticoagulation use after PFO closure.

### Conditions Module

**Conditions:**

- Patent Foramen Ovale

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** Surgery of PFO closure

**Name:** PFO closure

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** ischemic stroke, Hemorrhagic stroke or transient ischemic attack

**Time Frame:** 1 month, 6 months, 1 year, 3 years, 5 years

#### Secondary Outcomes

**Measure:** atrial fibrillation

**Time Frame:** 1 month, 6 months, 1 year, 3 years, 5 years

**Measure:** Hemorrhage related to the use of antithrombotic drugs

**Time Frame:** 1 month, 6 months, 1 year, 3 years, 5 years

**Measure:** residual leaks

**Time Frame:** 1 month, 6 months, 1 year, 3 years, 5 years

**Measure:** death

**Time Frame:** 1 month, 6 months, 1 year, 3 years, 5 years

**Measure:** open-heart surgery

**Time Frame:** 1 month, 6 months, 1 year, 3 years, 5 years

**Measure:** Other severe events related to PFO closure

**Time Frame:** 1 month, 6 months, 1 year, 3 years, 5 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* All patients who underwent PFO closure

Exclusion Criteria:

* Unable to complete or adhere to the study

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** All patients who underwent PFO closure and willing to participate in this study.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** yinclmail@163.com

**Name:** Chunlin Yin

**Phone:** 13552566227

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006344

- Term: Heart Septal Defects, Atrial

- ID: D000006343

- Term: Heart Septal Defects

- ID: D000006330

- Term: Heart Defects, Congenital

- ID: D000018376

- Term: Cardiovascular Abnormalities

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000006331

- Term: Heart Diseases

- ID: D000000013

- Term: Congenital Abnormalities

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M27570

- Name: Foramen Ovale, Patent

- Relevance: HIGH

- As Found: Patent Foramen Ovale

- ID: M9431

- Name: Heart Septal Defects

- Relevance: LOW

- As Found: Unknown

- ID: M9432

- Name: Heart Septal Defects, Atrial

- Relevance: LOW

- As Found: Unknown

- ID: M9418

- Name: Heart Defects, Congenital

- Relevance: LOW

- As Found: Unknown

- ID: M12

- Name: Congenital Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M20503

- Name: Cardiovascular Abnormalities

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000054092

- Term: Foramen Ovale, Patent

### Misc Info Module

- Version Holder: 2024-05-31
