Safety & Clinical Performance Study of Catheter Ablation With the Centauri System for Patients With Atrial Fibrillation

NCT04523545 | Unknown FDA Device

• 1 other identifier: CSP-00007
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, single-arm, open-label study following patients to 1 year, to evaluate the safety and performance of the Centauri System for catheter ablation of atrial fibrillation (AF). The study is intended for adult patients (age 18-75 years) who are indicated for a first-time catheter ablation of AF where the pre-procedure treatment plan contemplates pulmonary vein isolation (PVI) in patients with paroxysmal AF (PAF) or short-duration (\<1 year) persistent AF (PeAF).

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (3)

• Rate of device and procedure related serious adverse events

  The rate of system-related and procedure-related serious adverse events (SAEs)

  30 days

• Acute Procedural Success

  Proportion of patients with confirmed pulmonary vein isolation (PVI) during the index procedure

  During treatment procedure

• Chronic Feasibility: Proportion of patients with documented electrical isolation of the pulmonary veins

  Proportion of patients with documented electrical isolation of the pulmonary veins

  90 days

Study Arms (1)

Treatment

EXPERIMENTAL

Device: cardiac ablation

Interventions

cardiac ablation DEVICE

cardiac ablation using pulsed electric field energy to cause pulmonary vein isolation

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Failure of at least one antiarrhythmic drug (AAD) (Class I - IV) for AF, as evidenced by recurrent symptomatic AF or intolerable side effects due to AAD
• Diagnosis of recurrent symptomatic paroxysmal AF (PAF) or short duration (\< 1 year) Persistent AF (PeAF) with the following documentation:
• a. PAF i. Physician's note indicating symptoms consistent with recurrent symptomatic PAF AND ii. ≥ 2 episodes of PAF within 12 months prior to enrollment. At least one episode should be documented by ECG, transtelephonic monitor (TTM), Holter monitor, telemetry strip or similar, showing at least 30 seconds of AF b. PeAF i. Physician's note indicating symptoms consistent with continuous AF episode lasting longer than 7 days but less than 1 year AND ii. Any 24-hour continuous ECG recording documenting persistent AF within 6 months prior to enrollment OR iii. Two ECGs from any form of rhythm monitoring showing continuous AF taken at least 7 days apart within 12 months prior to enrollment OR iv. History of direct current cardioversion (DCCV) performed within 12 months prior to enrollment
• Patient is indicated for an ablation procedure according to society guidelines or investigational site practice
• Patient is willing and able to give informed consent.
• Patient is willing, able and committed to participate in baseline and follow-up evaluations for the duration of the study.

You may not qualify if:

• Long-standing persistent AF (continuous AF sustained \> 1 year)
• AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes
• Left atrial anteroposterior diameter \> 5.0 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT) within 6 months prior to enrollment
• Use of amiodarone within 6 weeks prior to enrollment
• Prior left atrial ablation or surgical procedure (including left atrial appendage (LAA) device or occlusion)
• Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period
• Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
• Presence of any pulmonary vein stents
• Presence of any pre-existing pulmonary vein stenosis
• Pre-existing hemidiaphragmatic paralysis
• Atrial or ventricular septal defect closure
• Atrial myxoma
• Presence of any prosthetic heart valve
• Hemodynamically significant valvular disease
• History of pericarditis

Sponsors & Collaborators

• Galaxy Medical, Inc.: lead

Study Sites (1)

University Hospital of Split

Split, 21000, Croatia

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Vikramaditya Mediratta, MS

CONTACT

714-717-2376; vmediratta@galaxymedical.com

James Stambaugh

CONTACT

408-718-6834; jstambaugh@galatherapeutics.com

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: August 19, 2020
• First Posted: August 21, 2020
• Study Start: September 28, 2020
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: August 22, 2022

Record last verified: 2022-08

Locations

CR (1)