Atrial Fibrillation Paroxysmal Clinical Trial
Official title:
Right Anterior Ganglionated Plexus Ablation Without Pulmonary Vein Isolation for the Treatment of Vagally-mediated Paroxysmal Atrial Fibrillation.
NCT number | NCT05461859 |
Other study ID # | 42/2022/B |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 16, 2020 |
Est. completion date | January 1, 2023 |
Verified date | November 2023 |
Source | St. Joseph's Centre, Poland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 18 |
Est. completion date | January 1, 2023 |
Est. primary completion date | July 19, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Poland | St. Joseph's Heart Rhythm Center | Rzeszów |
Lead Sponsor | Collaborator |
---|---|
St. Joseph's Centre, Poland |
Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | AF recurrence | AF episode lasting 30s or more, documented on 12-lead ECG, event or Holter monitor | 1 year |
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