## Protocol Section
### Identification Module
**NCT ID:** NCT04398979

**Brief Title:** Surgical Ablation for Atrial Fibrillation

**Official Title:** Minimally Invasive Surgical Ablation for Standalone Atrial Fibrillation

#### Organization Study ID Info
**ID:** JPSH-AF2012
#### Organization
**Class:** OTHER
**Full Name:** Nanjing Medical University
### Status Module
#### Completion Date
**Date:** 2020-02-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2020-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2020-05-19

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2019-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2012-01-01

**Type:** ACTUAL

**Status Verified Date:** 2020-05

#### Study First Post Date
**Date:** 2020-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2020-05-19
**Study First Submit QC Date:** 2020-05-19
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Nanjing Medical University

#### Responsible Party

**Investigator Affiliation:** Nanjing Medical University

**Investigator Full Name:** Hong Liu

**Investigator Title:** Investigator of the First Hospital of Nanjing Medical University

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** Minimally invasive approaches for surgical treatment have been advocated as a treatment option for stand-alone atrial fibrillation (AF). This study will investigate the clinical outcomes after minimally invasive surgical ablation of both paroxysmal and persistent/longstanding persistent AF.

**Detailed Description:** Atrial fibrillation (AF) patients with a previous stroke are often at a high risk of recurrent stroke and bleeding. Minimally invasive approaches for surgical treatment have been advocated as a treatment option for stand-alone AF. This study will investigate the clinical outcomes after minimally invasive surgical ablation of both paroxysmal and persistent/longstanding persistent AF. Neurological safety will be assessed by cerebral magnetic resonance, neuropsychological examination and periprocedural transcranial Doppler measurement.

### Conditions Module

**Conditions:**

- Atrial Fibrillation

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 300

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** After blunt dissection of the oblique and transverse sinus, an AtriCure Lumitip Dissector was introduced around the pulmonary veins. Pulmonary vein isolation was achieved with an AtriCure Isolator Synergy ablation clamp around the pulmonary vein antrum at least six times for each side. Ganglionated plexus identification and ablation were performed using an AtriCure Synergy ablation pen. The additional superior and inferior ablation lines connecting the bilateral pulmonary vein isolations were created by applying the AtriCure Synergy ablation pen. Following completion of the ablation on the right side, ablation on the left side was accomplished in a similar manner. The ligament of Marshall was dissected by electrical cautery. Conduction block was confirmed upon completion of the ablation procedure on the left side.

**Name:** Thoracoscopic Atrial fibrillation Ablation

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Number of patients with sinus rhythm, without detections of atrial arrhythmias (episodes longer than 30 seconds)

**Measure:** efficacy - sinus rhythm

**Time Frame:** 1 year

#### Secondary Outcomes

**Description:** conversion to sternotomy, bleeding, thromboembolic events, tamponade, haemothorax, pneumothorax, pleural effusion, pneumonia

**Measure:** periprocedural complications - surgery

**Time Frame:** 30 days after surgery

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients age \> 18 years
* Patients with paroxysmal, or persistent/long-standing persistent AF according to the standard EHRA definition.
* Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication.
* Absence of significant structural heart disease (dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular heart disease, untreated coronary artery disease)

Exclusion Criteria:

* AF secondary to a reversible cause (i.e., thyreopathy, etc.) Indication for open-heart surgery (coronary artery bypass grafting, valve surgery, etc.)
* Severe left ventricle dysfunction that is clearly caused by some other cardiac disease (dilated cardiomyopathy, ischaemic heart disease, etc.) where the AF is clearly of secondary etiology
* Known severe pericardial and pleural adhesions (e.g., history of cardiac surgery)

**Maximum Age:** 85 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** patients with symptomatic, drug-resistant, stand-alone, paroxysmal, persistent or long-standing persistent atrial fibrillation

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

### References Module

#### References

**Citation:** Tanaka K, Koga M, Lee KJ, Kim BJ, Park EL, Lee J, Mizoguchi T, Yoshimura S, Cha JK, Lee BC, Nakahara J, Suzuki N, Bae HJ, Toyoda K; CRCS-K Investigators and the SAMURAI Study Investigators. Atrial Fibrillation-Associated Ischemic Stroke Patients With Prior Anticoagulation Have Higher Risk for Recurrent Stroke. Stroke. 2020 Apr;51(4):1150-1157. doi: 10.1161/STROKEAHA.119.027275. Epub 2020 Feb 26. Erratum In: Stroke. 2020 May;51(5):e99.

**PMID:** 32098607

## 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: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4586

- Name: Atrial Fibrillation

- Relevance: HIGH

- As Found: 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

### Misc Info Module

- Version Holder: 2024-05-24
