Recruiting

PFA Systems

Sponsor:

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Code:

NCT07883629

Conditions

AF - Atrial Fibrillation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Pulse Field Ablation

Study Details

Brief summary:

This study randomizes patients undergoing PFA for A Fib to one of two standard care PFA systems. The patient will have an ICM placed to continuously monitor their heart rhythm. Follow up visits will occur until Month 36, and will include 12-lead ECG, ICM interrogation, AE updates, and QOL surveys.

Conditions

AF - Atrial Fibrillation

Study ID

NCT07883629

Start date

Jul 10, 2026

Status verified date

Apr, 2026

Completion date

May 30, 2031

Anticipated

Primary completion date

Aug 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion 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

Exclusion Criteria:

  • 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
  • Any of the following within the 3-months prior to enrollment:

  • 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

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: PFA System A

Pulse Field System A through a standard ablation catheter

active comparator: PFA System B

Pulse Field System A through a standard ablation catheter

Interventions

Pulse Field Ablation

Pulse Field Ablation

Primary outcome measure

  • Number of participants free of AF, AFl, or AT recurrence [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Amit Thosani, MD

412-359-3457amit.thosani@ahn.org

Caitlin Phalunas, Lead CRC

412-359-3747caitlin.phalunas@ahn.org

Locations

Allegheny General Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15212

Contacts

Heather McDonald, MHA, CCRC

412-359-3660heather.mcdonald@ahn.org

Principal Investigator:

Amit Thosani, MD

More Information

Sponsor

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

Last update posted

Oct 20, 2026

Last verified

Apr, 2026

Keywords

  • Symptomatic AF
  • Persistent AF

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-21. This information was provided to ClinicalTrials.gov by Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) on 2026-10-20. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.