NCT06058468Not yet recruiting
Cardioneuroablation vs Pulmonary Vein Isolation in Treatment of Paroxysmal Atrial Fibrillation
Cardioneuroablation of Right Anterior Ganglionated Plexus vs Pulmonary Vein Isolation in Patients With Paroxysmal Atrial Fibrillation and Enhanced Vagal Tone
Source: ClinicalTrials.gov · Last updated 29 Sept 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this study is to compare effectiveness of cardioneuroablation of right anterior ganglionated plexus and pulmonary vein isolation in patients with enhanced vagal tone expressed as deceleration capacity \>7.5ms.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 21 Sept 2023
- Start date
- Jan 2024
- Primary completion date
- Jan 2028
- Lead sponsor
- St. Joseph's Centre, Poland
- Diseases
- Atrial fibrillation
- NCT number
- NCT06058468
What you commit to
- Study type: Interventional
- Planned participants: 160
- From Jan 2024 to the primary completion date, Jan 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous ablation of atrial fibrillation or atrial flutter
Other illness
- AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other non-heart related causes
- Clinically significant arrhythmias other than AF
- Significant valvular disease
- Heart failure III or IV Class in New York Heart Association Classification
- History of a patent foramen ovale/atrial septal defect closure
- History of left atrial appendage closure
- Presence of a cardiac pacemaker, defibrillator or cardiac resynchronization therapy device
- History of pericarditis
- Congenital heart disease
- History of bleeding or coagulation disorders
- History of transplantation
- Severe lung disease
- Cancer
- Significant infection
- Mental disorders
Lab values
- Chronic renal failure defined as estimated glomerular filtration rate (eGFR) \<30 mL/min/m2
Other
- Permanent AF lasting more than one year or persistent AF lasting more than 7 days
- Anteroposterior dimension of the left atrium in the echocardiography ≥43mm
- Valve prosthesis
- Atrial myxoma
- Contraindications to oral anticoagulation
- Contraindications to computed tomography or magnetic resonance imaging
- Pregnancy or breast-feeding
- BMI\>31
- Life expectancy less than one year
- Lack of informed consent to participate in the trial
Who the study is looking for
- Paroxysmal atrial fibrillation documented in ECG or Holter monitoring
- Deceleration capacity \>7.5ms
- Life expectancy more than 1 year
- Age ≥18 years
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.