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New treatment option for Atrial Fibrillation (AF)
Official title Assessment of Pulmonary Vein Isolation Using a Balloon Catheter With Pulsed Field Energy in Atrial Fibrillation
ClinicalTrials.gov ID: NCT07156877
What this study is testing
- What it's testing
- The goal of this clinical trial is to evaluate whether pulsed field ablation (PFA) using the novel VOLT catheter is as safe and effective as conventional thermal ablation (radiofrequency or cryotherapy) for the treatment of atrial fibrillation (AF) in adult patients undergoing their first pulmonary vein isolation (PVI). The main questions it aims to answer are: Is PFA with the VOLT catheter non-inferior to thermal ablation in preventing recurrence of atrial tachyarrhythmias 2-12 months after the procedure?
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
- Paroxysmal or persistent atrial fibrillation documented on a 12 lead electrocardiogram or Holter monitor (lasting ≥30 seconds) within the last 24...
- Candidate for ablation based on current AF guidelines
- Continuous anticoagulation with Vitamin-K-Antagonists or a non-vitamin K antagonist anticoagulant (NOAC) for ≥4 weeks prior to the ablation; or a...
- Age of 18 years or older on the date of consent
- Informed consent as documented by signature
You likely can't join if
- History of left atrial (LA) ablation or surgery involving the LA
- Persistent atrial fibrillation (AF) lasting longer than 12 months
- AF resulting from temporary or reversible causes
- Presence of thrombus within the heart chambers
- Prior pulmonary vein (PV) stenosis or stenting
- Existing paralysis of one side of the diaphragm
See the full eligibility criteria
- Paroxysmal or persistent atrial fibrillation documented on a 12 lead electrocardiogram or Holter monitor (lasting ≥30 seconds) within the last 24 months.
- Candidate for ablation based on current AF guidelines
- Continuous anticoagulation with Vitamin-K-Antagonists or a non-vitamin K antagonist anticoagulant (NOAC) for ≥4 weeks prior to the ablation; or a transesophageal echocardiogram (TEE) and/or computed tomography (CT) that...
- Age of 18 years or older on the date of consent
- Informed consent as documented by signature
- History of left atrial (LA) ablation or surgery involving the LA
- Persistent atrial fibrillation (AF) lasting longer than 12 months
- AF resulting from temporary or reversible causes
- Presence of thrombus within the heart chambers
- Prior pulmonary vein (PV) stenosis or stenting
- Existing paralysis of one side of the diaphragm
- Known allergy or contraindication to anticoagulant medication or contrast agents
- History of mitral valve surgery
- Significant mitral valve disease
- Myocardial infarction occurring within three months prior to informed consent
- Current use of triple antithrombotic therapy
- Cardiac surgery within the past three months or a scheduled cardiac surgery or TAVI
- Major congenital heart abnormalities
- Congestive heart failure classified as NYHA class III or IV
- Left ventricular ejection fraction (LVEF) less than 35%
- Diagnosed hypertrophic cardiomyopathy (wall thickness exceeding 1.7 cm)
- Severe chronic kidney disease (eGFR below 30 ml/min)
- Uncontrolled hyperthyroidism
- Stroke or transient ischemic attack (TIA) within three months before consent
- Active systemic infections
- History of cryoglobulinemia
- Diagnosed cardiac amyloidosis
- Current pregnancy
- Estimated life expectancy under one year, as judged by the treating physician
- Enrollment in another clinical study that may interfere with this trial's outcomes
- Inability or unwillingness to adhere to study requirements and follow-up visits
The study team makes the final eligibility decision.
Where it's taking place
- Bruges, Belgium
- Jette, Belgium
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 Bruges, Belgium; Jette, Belgium. 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.