MedDataX Logo

Cardioneuroablation for the Treatment of Vagally-mediated Atrial Fibrillation.

NCT ID: NCT05461859

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-16

Study Completion Date

2023-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Pulmonary vein isolation (PVI) is a cornerstone for catheter ablation of atrial fibrillation (AF), however, exact mechanisms of PVI efficacy remain debatable. It has been postulated that in patients with increased vagal tone AF can be treated by attenuation of parasympathetic drive to the heart using cardioneuroablation (CNA) by means of radiofrequency (RF) of the ganglionated plexi, however, data in literature and guidelines are lacking. The objective of this study is to examine the mid-term efficacy of RF-CNA targeting the right anterior ganglionated plexus (RAGP) in management of AF using right-atrial approach only.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Calculation of deceleration capacity (DC) was derived from the result of 1-minute monitoring of R-R intervals recorded using electrophysiology (EP) system.

Double access to the right femoral vein was obtained under ultrasound guidance. Four- or ten-pole diagnostic electrode was introduced into the coronary sinus and an open-irrigated or 8 mm ablation catheter (AC) was advanced into the superior vena cava. The location of RAGP was determined purely anatomically at the sites of fragmented potentials below the superior vena cava ostium and the superior-septal aspect of the right atrium in the left anterior oblique (LAO) view and was guided fluoroscopically. RF applications were delivered and were continued until heart rate (HR) acceleration \>30% was achieved or RF time exceeded 120 s.

Clinical follow-up (FU) consisted of multiple ambulatory visits with standard ECG and a 7-day Holter during the FU period. During FU visits, a detailed history of any palpitations, episodes of AF, and hospitalizations for cardiac arrhythmias was collected.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation Paroxysmal

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

≥30% HR increase after CNA

Patients in whom ≥30% increase in HR after CNA of RAGP was achieved.

Cardioneuroablation (CNA) of the right anterior ganglionated plexus (RAGP)

Intervention Type PROCEDURE

CNA of RAGP

<30% HR increase after CNA

Patients in whom ≥30% increase in HR after CNA of RAGP was \*not\* achieved.

Cardioneuroablation (CNA) of the right anterior ganglionated plexus (RAGP)

Intervention Type PROCEDURE

CNA of RAGP

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cardioneuroablation (CNA) of the right anterior ganglionated plexus (RAGP)

CNA of RAGP

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Paroxysmal atrial fibrillation
* Deceleration capacity \>7ms

Exclusion Criteria

* Permanent AF lasting more than one year or persistent AF lasting more than 7 days
* AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other non-heart related causes
* Anteroposterior dimension of the left atrium in the echocardiography ≥ 5.5 cm
* Significant valvular disease
* Prosthetic valve
* Heart failure New York Heart Association (NYHA) class III/IV
* Previous AF ablation
* History of a persistent oval opening/atrial septal defect closure
* History of left atrial appendage closure
* Atrial myxoma
* Presence of a cardiac pacemaker, defibrillator or cardiac resynchronization therapy device
* Symptomatic hypotension
* History of pericarditis
* Congenital heart disease
* History of coagulation disorders
* Contraindications to oral anticoagulation
* Contraindications to computed tomography or magnetic resonance imaging
* History of transplantation
* Severe lung disease
* Chronic renal failure defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/m2
* Cancer
* Significant infection
* Life expectancy less than one year
* Lack of informed consent to participate in the trial
* Participation in another trial
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

St. Joseph's Centre, Poland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Piotr Futyma

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

St. Joseph's Heart Rhythm Center

Rzeszów, , Poland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Poland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

42/2022/B

Identifier Type: -

Identifier Source: org_study_id