## Protocol Section
### Identification Module
**NCT ID:** NCT05173779

**Brief Title:** Left Atrial Isolation by Catheter Ablation in Persistent Atrial Fibrillation With Severe Atrial Fibrosis

**Official Title:** A Single-arm Study to Evaluate the Efficacy and Safety of Left Atrial Isolation Achieved by Catheter Ablation in Patients With Persistent Atrial Fibrillation and Severe Atrial Fibrosis: a Chinese Registry Study

#### Organization Study ID Info
**ID:** LAICA
#### Organization
**Class:** OTHER
**Full Name:** Shanghai Chest Hospital
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2022-08-10

**Type:** ACTUAL

**Last Update Submit Date:** 2022-08-09

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-01-01

**Type:** ESTIMATED

**Status Verified Date:** 2022-08

#### Study First Post Date
**Date:** 2021-12-30
**Type:** ACTUAL
**Study First Submit Date:** 2021-12-14
**Study First Submit QC Date:** 2021-12-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Shanghai Chest Hospital

#### Responsible Party

**Investigator Affiliation:** Shanghai Chest Hospital

**Investigator Full Name:** Xu Liu

**Investigator Title:** Professor, deputy director of cardiology department of Shanghai Chest Hospital

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This is a single-arm clinical trial evaluating the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.

**Detailed Description:** This is a single-arm clinical trial. Patients with persistent atrial fibrillation with severe atrial fibrosis are enrolled as subjects to conduct left atrial isolation by catheter ablation. Postoperative recurrence rate and other indicators are analyzed to evaluate the efficacy and safety of left atrial isolation achieved by catheter ablation in patients with persistent atrial fibrillation with severe atrial fibrosis.

### Conditions Module

**Conditions:**

- Persistent Atrial Fibrillation

**Keywords:**

- Persistent Atrial Fibrillation

- Severe atrial fibrosis

- Left atrial isolation

- catheter ablation

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All the enrolled subjects will receive left atrial isolation through catheter ablation.

**Intervention Names:**

- Procedure: Left atrial isolation by catheter ablation

**Label:** Left atrial isolation arm

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Left atrial isolation arm

**Description:** Procedure: Right pulmonary vein circumferential isolation + anterior left atrial line (superior mitral annulus to right superior pulmonary vein via the anterior wall) + para-septal line (para-septal mitral annulus to the right inferior pulmonary vein, including right atrial components-especially in and around the proximal coronary sinus) + posterior left atrial line (superior mitral annulus to right superior pulmonary vein via the posterior wall).

**Name:** Left atrial isolation by catheter ablation

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** AF/AFL/AT recurrence is defined as presence of documented AF/AFL/AT episodes of 30 seconds or longer duration

**Measure:** Postoperative atrial fibrillation (AF)/atrial flutter (AFL)/atrial tachycardia (AT) recurrence rate

**Time Frame:** up to 18 months after enrollment

#### Secondary Outcomes

**Description:** AF recurrence is defined as presence of documented AF episodes of 30 seconds or longer duration

**Measure:** Postoperative AF recurrence rate

**Time Frame:** up to 18 months after enrollment

**Description:** Occurrence of AFL/AT is defined as presence of documented AFL/AT episodes of 30 seconds or longer duration

**Measure:** Postoperative AFL/AT rate

**Time Frame:** up to 18 months after enrollment

**Description:** including death, atrio-esophageal fistula, cardiac tamponade/perforation, myocardial infarction, stroke/cerebrovascular accident, thromboembolism, diaphragmatic paralysis, pneumothorax, pleural effusion, heart block, pulmonary vein stenosis, pulmonary edema, left atrial thrombus, pericarditis and major vascular access complication or bleeding

**Measure:** Incidence of complications

**Time Frame:** up to 18 months after enrollment

**Measure:** Changes in the diameter of the left atrium and the left ventricular ejection fraction

**Time Frame:** up to 18 months after enrollment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Aged 18 to 80 years old
2. Persistent AF with severe atrial fibrosis and left atrial anterioposterior diameter \> 50mm
3. Nonresponse or intolerance to ≥1 antiarrhythmic drug
4. CHA2DS2-VASc ≥ 3 and HAS-BLED \< 3

Exclusion Criteria:

1. With uncontrolled congestive heart failure;
2. Having significant valvular disease;
3. Having moderate-to-severe pulmonary hypertension;
4. With myocardial infarction or stroke within 6 months of screening;
5. With Significant congenital heart disease;
6. Ejection fraction was \<40% measured by echocardiography;
7. Allergic to contrast media;
8. Contraindication to anticoagulation medications;
9. Severe pulmonary disease e.g. restrictive pulmonary disease, chronic obstructive disease (COPD);
10. Left atrial thrombus;
11. Having any contraindication to right or left sided heart catheterization

**Maximum Age:** 80 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** qinmuae@163.com

**Name:** Mu Qin, M.D.

**Phone:** +8613052320103

**Role:** CONTACT

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000001145

- Term: Arrhythmias, Cardiac

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC14

- Name: Heart and Blood Diseases

### Condition Browse Module - Browse Leaves

- ID: M8485

- Name: Fibrosis

- Relevance: HIGH

- As Found: Fibrosis

- ID: M4586

- Name: Atrial Fibrillation

- Relevance: HIGH

- As Found: Persistent Atrial Fibrillation

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001281

- Term: Atrial Fibrillation

- ID: D000005355

- Term: Fibrosis

### Misc Info Module

- Version Holder: 2024-05-24
