AF - Atrial Fibrillation study: Pulse Field Ablation
Official title Comparison of Two Pulse Field Ablation Systems for AF Ablation
ClinicalTrials.gov ID: NCT07883629
What this study is testing
- What it's testing
- This study randomizes patients undergoing PFA for A Fib to one of two standard care PFA systems.
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 89
You may be able to join if
- Symptomatic AF
- Persistent AF
- De novo AF ablation
- Males and Females Age 18 to 89 years of age, inclusive
- Willing and capable to provide informed consent
You likely can't join if
- AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes
- Contraindication to, or unwillingness to use, systematic anticoagulation
- Left ventricular ejection fraction LVEF 30% as documented by TTE (within 3 months prior)
- Left atrial volume index \>60 ml/m2
- LA anteroposterior dimension 5.5 cm
- Presence of intramural thrombus, tumor or other abnormality that precludes safe catheter introduction or manipulation
See the full eligibility criteria
- Symptomatic AF
- Persistent AF
- De novo AF ablation
- Males and Females Age 18 to 89 years of age, inclusive
- Willing and capable to provide informed consent
- Able and willing to participate in all examinations and follow-up visits and tests associated with this clinical study
- AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes
- Contraindication to, or unwillingness to use, systematic anticoagulation
- Left ventricular ejection fraction LVEF 30% as documented by TTE (within 3 months prior)
- Left atrial volume index \>60 ml/m2
- LA anteroposterior dimension 5.5 cm
- Presence of intramural thrombus, tumor or other abnormality that precludes safe catheter introduction or manipulation
- BMI \>35 kg/m2
- Chronic renal insufficiency of \<15 mL/min/1.73 m2 or any history of renal dialysis, or history of renal transplant
- Clinically significant systemic infection or sepsis
- Myocardial infarction
- Unstable angina
- Percutaneous coronary intervention
- Heart failure hospitalization
- Stroke or TIA
- Significant bleeding
- Pericarditis/effusions
- Left atrial thrombus
- Coronary artery bypass grafting/atriotomy within 6 months prior
- Contraindication for oral anticoagulation
- Organ or hematologic transplant, or currently being evaluated for an organ transplant Women who are pregnant or breastfeeding
The study team makes the final eligibility decision.
Where it is enrolling
- Pittsburgh, Pennsylvania, United States
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, but 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 89 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Pittsburgh, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.