N/A
N=15
A Single Arm Pilot Study of Pulsed Field Ablation in the Treatment of Paroxysmal Atrial Fibrillation
Paroxysmal Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT04474054 ↗Enrolled (actual)
15
Serious AEs
33.3%
Results posted
Apr 2023
Primary outcome: Primary: Occurence of Device-or Procedure-related Early and Late-onset of Serious Adverse Events — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Catheter ablation to treat paroxysmal atrial fibrillation (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Boston Scientific Corporation
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurence of Device-or Procedure-related Early and Late-onset of Serious Adverse Events |
— | — |
| PRIMARY Freedom From Recurrence of Symptomatic Atrial Fibrillation, Atrial Tachycardia or Atrial Flutter |
10 | — |
Summary
The objective of this pilot study is to confirm that endocardial ablation using the FARAPULSE Ablation System Plus with commercial design devices is both safe and effective for treating drug-resistant paroxysmal atrial fibrillation (PAF).
Eligibility Criteria
Inclusion Criteria:Study subjects are required to meet all the following inclusion criteria to participate in this study:
- Patients with documented drug resistant symptomatic PAF
- Patients who are ≥ 18 and ≤ 75 years of age on the day of enrollment.
- Patient participation requirements:
- Lives locally.
- Is willing and capable of providing Informed Consent to undergo study procedures.
- Is willing to participate in all examinations and follow-up visits and tests associated with this clinical study.
Exclusion Criteria: Subjects will be excluded from participating in this study if they meet any one of the following exclusion criteria:
- AF that is:
- Persistent
- Secondary to electrolyte imbalance, thyroid disease, alcohol abuse or other reversible / non-cardiac causes
- Longstanding
- Left atrial anteroposterior diameter ≥ 5.0 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT)
- Any of the following cardiac procedures, implants or conditions:
- Clinically significant arrhythmias other than AF, AFL or AT
- Previous endocardial or epicardial ablation or surgery for AF
- Hemodynamically significant valvular disease
- Prosthetic heart valve
- Heart Failure for example NYHA Class III or IV CHF, LVEF 40
- Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
- Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea
- Renal insufficiency with an estimated creatinine clearance < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
- Active malignancy or history of treated cancer within 24 months of enrollment
- Clinically significant gastrointestinal problems involving the esophagus, stomach and/or untreated acid reflux
- Clinically significant infection
- Predicted life expectancy less than one year
- Clinically significant psychological condition that in the investigator's opinion would prohibit the subject's ability to meet the protocol requirements
- Current or anticipated enrollment in any other clinical study
Data sourced from ClinicalTrials.gov (NCT04474054). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.