BridgeMD
New treatment option for Atrial Fibrillation (AF)
Official title Evaluation of the Impact of Pulsed Field Ablation on Autonomic Nervous System Modulation in Paroxysmal Atrial Fibrillation
ClinicalTrials.gov ID: NCT06647485
What this study is testing
- What it's testing
- The objective of this clinical trial is to evaluate the impact of pulse field (PF) energy, both alone and in combination with radiofrequency (RF) energy, on vagal modulation during point-by-point pulmonary vein isolation (PVI) in patients with paroxysmal atrial fibrillation (PAF). The effect of PF energy on ganglionated plexi (GP) will be assessed using heart rate variability (HRV) as a surrogate marker.
- 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 to 70
You may be able to join if
- Symptomatic Paroxysmal Atrial Fibrillation (AF) that terminates spontaneously or with intervention within 7 days of onset
- Age range: 18-70 years
- Willing and capable of providing informed consent
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
You likely can't join if
- Previously diagnosed Persistent AF (\> 7 days in duration)
- Previous LA ablation
- Previous cardiac surgery
- Myocardial Infarction within the previous 3 months
- Severely compromised Left Ventricular Ejection Fraction (LVEF\<40%)
- Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the...
See the full eligibility criteria
- Symptomatic Paroxysmal Atrial Fibrillation (AF) that terminates spontaneously or with intervention within 7 days of onset
- Age range: 18-70 years
- Willing and capable of providing informed consent
- Able and willing to comply with all pre-, post-, and follow-up testing and requirements
- Previously diagnosed Persistent AF (\> 7 days in duration)
- Previous LA ablation
- Previous cardiac surgery
- Myocardial Infarction within the previous 3 months
- Severely compromised Left Ventricular Ejection Fraction (LVEF\<40%)
- Presence of implanted pacemaker or Implantable Cardioverter-Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the pulsed electric field energy
- Acute illness, active systemic infection, or sepsis
- Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.
- Severe mitral regurgitation
- Woman who are pregnant, lactating, or who are planning to become pregnant during the course of the clinical investigation
The study team makes the final eligibility decision.
Where it's taking place
- Aalst, Belgium, 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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalst, Belgium, 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.