Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation

NCT05426759 | Completed Results

• 1 other identifier: CIP-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

A prospective single-arm study of ganglionated plexi ablation in cardiothoracic surgery patients with a history of atrial fibrillation.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• The Number of Patients in Sinus Rhythm at 12 Months.

  Patients will be monitored with 24 hour Holter at 12 months

  12 month

Secondary Outcomes (1)

• Extension of AERP

  Day 0

Study Arms (1)

GP Ablation

EXPERIMENTAL

Single arm study with GP ablations performed during open-chest surgery

Device: Pulsed Field Ablation of epicardial Ganglionated Plexi.

Interventions

Pulsed Field Ablation of epicardial Ganglionated Plexi. DEVICE

Using Pulsed Field Ablation (PFA), delivered via an epicardial catheter, to selectively ablate the ganglionated plexi (GP) on the epicardial surface of the heart.

GP Ablation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age is between 18 and 70 years.
• Scheduled for open-chest cardiothoracic surgery, for coronary artery bypass grafting and/or aortic valve repair/replacement
• Have a documented medical history of paroxysmal or early-stage persistent atrial fibrillation within the previous 12 months.
• Legally competent and willing to sign the informed consent.
• Life expectancy of at least 2 years.

You may not qualify if:

• Previous cardiac surgery
• Prior pericardial interventions
• Prior endocardial or epicardial pulmonary vein isolation (PVI), or any other invasive AF therapy
• Previous or existing pericarditis
• Use of amiodarone within the previous 12 months.
• Long-standing persistent atrial fibrillation
• Indication for mitral or tricuspid valve surgery
• Indication for concomitant left atrial appendage (LAA) ligation or excision
• History of previous radiation therapy on the thorax
• History of previous thoracotomy.
• Prior electrical or mechanical isolation of the Left Atrial Appendage (LAA)
• The presence of LAA occlusion devices, coronary stents, prosthetic heart valves, pacemakers or implantable cardioverter defibrillators (ICDs)
• Myocardial infarction within the previous 2 months
• New York Heart Association (NYHA) Class IV heart failure symptoms
• Left Ventricular Ejection Fraction (LVEF) \< 40%, measured by transthoracic echocardiography (TTE)

Sponsors & Collaborators

• Atrian Medical Ltd.: lead

Study Sites (1)

Tbilisi Heart & Vascular Clinic

Tbilisi, Georgia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Barry O'Brien PhD
• Organization: AtriAN Medical Ltd

barry.obrien@atrianmedical.com

+353872934292

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2022
• First Posted: June 22, 2022
• Study Start: June 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GE (1)