BridgeMD
New treatment option for Atrial Fibrillation (Paroxysmal)
Official title Pulsed Field Ablation With Concomitant Radiofrequency Cardioneuroablation in Patients With Paroxysmal Atrial Fibrillation
ClinicalTrials.gov ID: NCT07171463
What this study is testing
- What it's testing
- Pulsed-field ablation (PFA) is a novel, non-thermal method for the treatment of atrial fibrillation (AF). It uses short, high-voltage electrical pulses to selectively ablate cardiomyocytes.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years
- Documented paroxysmal atrial fibrillation (AF) lasting ≥30 seconds on ECG or Holter monitoring
- Willingness and ability to provide written informed consent
- Life expectancy \>1 year
You likely can't join if
- Persistent AF lasting \>7 days or long-standing AF \>1 year
- Secondary AF due to electrolyte imbalance, thyroid disease, alcohol abuse, or other non-cardiac causes
- Left atrial anteroposterior diameter ≥45 mm on transthoracic echocardiography
- Clinically significant coexisting arrhythmias other than AF
- Significant valvular heart disease or valve prosthesis
- Chronic heart failure NYHA class III/IV
See the full eligibility criteria
- Age ≥18 years
- Documented paroxysmal atrial fibrillation (AF) lasting ≥30 seconds on ECG or Holter monitoring
- Willingness and ability to provide written informed consent
- Life expectancy \>1 year
- Persistent AF lasting \>7 days or long-standing AF \>1 year
- Secondary AF due to electrolyte imbalance, thyroid disease, alcohol abuse, or other non-cardiac causes
- Left atrial anteroposterior diameter ≥45 mm on transthoracic echocardiography
- Clinically significant coexisting arrhythmias other than AF
- Significant valvular heart disease or valve prosthesis
- Chronic heart failure NYHA class III/IV
- Previous AF or atrial flutter ablation
- Prior closure of atrial septal defect or left atrial appendage
- Atrial myxoma
- Implanted pacemaker or defibrillator
- History of pericarditis
- Congenital heart disease
- Coagulopathy or bleeding disorders
- Contraindications to oral anticoagulation
- Contraindications to CT or MRI
- Pregnancy or breastfeeding
- Body Mass Index \>30
- History of organ transplantation
- Severe pulmonary disease
- Estimated Glomerular Filtration Rate \<30 mL/min/1.73 m²
- Active malignancy
- Significant infection
- Life expectancy \<1 year
- Psychiatric disorders preventing study participation
- Refusal or inability to provide informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Rzeszów, Podkarpackie Voivodeship, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rzeszów, Podkarpackie Voivodeship, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.