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Tests treatment safety and results for Atrial Fibrillation
Official title Safety and Performance of a Pulsed Field Device for Global Mapping and Ablation of the Left Atrium for the Treatment of Atrial Fibrillation
ClinicalTrials.gov ID: NCT05164107
What this study is testing
- What it's testing
- The purpose of this study is to provide clinical data pertaining to the safety and performance of the Globe Mapping and Pulsed Field Ablation System for treating subjects with atrial fibrillation (AF).
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 75
You may be able to join if
- people planned for an AF catheter ablation procedure, with a documented history of AF.
- Diagnosis must be confirmed within 12 months before enrollment.
- (Repeat ablations) Patient had 1 previous PVI procedure with cryoablation, radiofrequency ablation or pulsed field ablation
- people between 18 and 75 years of age, inclusive Key
You likely can't join if
- Patients who have contraindications to open heart surgery
- Patients from an Intensive Care Unit
- Patients with active systemic infection (sepsis)
- Patients who have had previous ablation in the left or right atrium
- Patients who are post-heart transplant or who are awaiting cardiac transplantation or other cardiac surgery
- Patients with cardiac implants that may interfere with device delivery or positioning (e.g. atrial septal defect closure device, left atrial...
See the full eligibility criteria
- people planned for an AF catheter ablation procedure, with a documented history of AF.
- Diagnosis must be confirmed within 12 months before enrollment.
- (Repeat ablations) Patient had 1 previous PVI procedure with cryoablation, radiofrequency ablation or pulsed field ablation
- people between 18 and 75 years of age, inclusive Key
- Patients who have contraindications to open heart surgery
- Patients from an Intensive Care Unit
- Patients with active systemic infection (sepsis)
- Patients who have had previous ablation in the left or right atrium
- Patients who are post-heart transplant or who are awaiting cardiac transplantation or other cardiac surgery
- Patients with cardiac implants that may interfere with device delivery or positioning (e.g. atrial septal defect closure device, left atrial appendage occluder)
- Patients with mitral valve prolapse or other heart valve abnormalities excepting mild to moderate mitral regurgitation
- Patients with New York Heart Association Class III or IV heart failure
- History of a documented thromboembolic event, including stroke or transient ischemic attack (TIA)
- Bleeding disorder history
- Patients with a known sensitivity to anesthesia or neuromuscular block agent
- Currently undergoing long-term treatment with steroids, not including intermittent use of inhaled steroids for respiratory disease
- Myocardial infarction within the last three months
- Atrioventricular (AV) block II° or III°
- Left ventricular ejection fraction (LVEF) of less than 35%
- Unstable angina
The study team makes the final eligibility decision.
Where it's taking place
- Prague, Czechia
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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Prague, Czechia. 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.