Prevention of Atrial Fibrillation After Cardiac Surgery by Posterior Pericardiotomy

NCT06728826 | Not Yet Recruiting DMC

• 1 other identifier: CHEC2024-397
• Study Type: interventional
• Target: 648
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of PREACT-AF is to learn if posterior pericardiotomy works to prevent the incidence of postoperative atrial fibrillation (POAF) in patients undergoing cardiac surgery. The main questions it aims to answer are: Does posterior pericardiotomy prevent the incidence of POAF for participants after cardiac surgery? What medical problems do participants have when undergoing posterior pericardiotomy?

Conditions

Atrial Fibrillation (AF); Cardiac Events

Outcome Measures

Primary Outcomes (1)

• In-hospital post-operative atrial fibrillation

  Number of patients with post-operative atrial fibrillation within the first 5 days postoperatively or up to hospital discharge, whichever occurs first

  Within 5 days after index cardiac surgery

Secondary Outcomes (6)

• Length of post-operative in-hospital stay

  Over the duration of the follow-up period to a common end date (mean follow-up of 5 years).

• Pericardial effusion without tamponade

  From index surgery completion to within 30 days of index surgery

• Death

  From index surgery completion to within 30 days of index surgery

• Ischemic stroke or systemic arterial embolism

  From index surgery completion to within 30 days of index surgery

• Hospital readmission or unplanned hospital visit

  From index surgery completion to within 30 days of index surgery

Other Outcomes (5)

• Number of patients with phrenic nerve injuries

  Within 30 days of index surgery

• Number of patients with left pleural interventions

  Within 30 days of index surgery

• Number of patients with esophageal injuries

  Within 30 days of index surgery

Study Arms (2)

Posterior Pericardiotomy Group

EXPERIMENTAL

The surgeon will perform posterior pericardiotomy during the patient's cardiac surgery.

Procedure: Posterior Pericardiotomy

No Posterior Pericardiotomy Group

NO INTERVENTION

The surgeon will not perform posterior pericardiotomy during the patient's cardiac surgery.

Interventions

Posterior Pericardiotomy PROCEDURE

The surgeon will perform a posterior pericardiotomy while the patient is on cardiopulmonary bypass. In detail, the surgeon will use cautery to make a 4- to 5-cm opening in pericardium between the left inferior pulmonary vein and the diaphragm. Then a soft channel drain will be placed through the posterior pericardium, the pericardiotomy and into the left pleural space.

Posterior Pericardiotomy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients greater than or equal to 18 years of age
• Requiring surgical intervention on the proximal aorta, cardiac valves, and/or coronary arteries
• Able to provide informed consent

You may not qualify if:

• History of atrial fibrillation or flutter
• Prior cardiac surgery requiring opening of the pericardium
• Previous surgical instrumentation of the left pleural cavity
• Patient undergoing minimally invasive cardiac surgery

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, 200433, China

Location

MeSH Terms

Conditions

Atrial Fibrillation; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lin Han, M.D. Ph.D.

  Naval Medical University Changhai Hospital

  PRINCIPAL INVESTIGATOR

• Hao Zhang, M.D. Ph.D.

  Naval Medical University Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hao Zhang, M.D. Ph.D.

CONTACT

86-21-31161765; 13818178916@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2024
• First Posted: December 11, 2024
• Study Start: January 1, 2025
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Locations

CN (1)