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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P240044 / PAS001 |
| Date Original Protocol Accepted |
06/23/2026
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| Date Current Protocol Accepted |
06/23/2026
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| Study Name |
PULSAR Post-Approval Study
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| Device Name |
Globe® Pulsed Field System
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| Clinical Trial Number(s) |
NCT05462145
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit.Adolescent B(as adults): 18 yrs < 22 yrs,
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
The PULSAR PAS study is a prospective, multicenter, non-randomized, single-arm clinical study to evaluate the long-term safety and effectiveness of the Globe PF System for treating patients with symptomatic paroxysmal atrial fibrillation.
Subjects who sign the informed consent are considered enrolled in the study. Enrolled subjects who satisfy all the eligibility criteria will then undergo the ablation procedure using the Globe PF System. After the study ablation procedure, subjects will enter a blanking period. The blanking period lasts for 90 days after the index ablation procedure, during which AF/AFL/AT recurrence, DC cardioversion, repeat ablation, and an increase in Antiarrhythmic Drug (AAD) dosage are not considered treatment failures. This is a standard window of time for a blanking period for AF ablation therapy studies.
The Primary Effectiveness Evaluation Period extends from the end of the blanking period to the 12-month visit.
The primary objectives of the PAS will be the following:
- Estimating the primary safety adverse event rate for ablation using the Globe Pulsed Field System.
- Estimating the rate of 12-month treatment success following ablation procedure using the Globe Pulsed Field System.
Secondary/Additional objectives will include but are not limited to:
- Estimating the rate of treatment success, evaluated at 24 months and 36 months following ablation procedure using the Globe Pulsed Field System.
- Estimating the rate of device- or procedure-related serious adverse events through 12 months post-ablation using the Globe Pulsed Field System.
- Estimating freedom from AF/AFL/AT recurrence and off Class I and III antiarrhythmic drugs at 12-, 24-, and 36-months following ablation procedure using the Globe Pulsed Field System.
- Characterizing procedural data.
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| Study Population |
This study will enroll up to 250 subjects diagnosed with PAF at up to 40 investigational sites in the US, Canada, and Europe. A minimum of approximately 50% of subjects will be enrolled at sites in the US. There will be a 20% subject enrollment limit per site.
The study is expected to include the Medicare population (patients older than 65) who meet the study inclusion/exclusion criteria. Therefore, the results of the study are expected to be generalizable to the Medicare population based on age and cardiovascular risk factors. As this trial will enroll Medicare beneficiaries in the US, all standards of Medicare coverage requirements will be followed.
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| Sample Size |
up to 250 subjects diagnosed with PAF
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| Key Study Endpoints |
Primary Effectiveness Endpoints:
The primary effectiveness endpoint is the rate of 12-month treatment success. Treatment success is defined as freedom from treatment failure. Treatment failure will include:
- Documented recurrence of atrial fibrillation, atrial flutter,7 atrial tachycardia (AF/AFL/AT) as evidenced by episodes greater than or equal to 30 seconds on Holter monitoring or equivalent8 during the effectiveness evaluation period (i.e., after the 90-day blanking period through 12 months), or by an episode documented on the entire recording of the 12-lead ECG (greater than or equal to 10 seconds) at the 12-month evaluation/visit.
- Acute procedural failure, defined as:
1. Inability to isolate all accessible targeted pulmonary veins (PV) (minimally assessed for entrance block and/or exit block) during the index procedure
2. Ablation using a non-study device in the left atrium (LA)
- Direct Current (DC) cardioversion for AF/AFL/AT during the effectiveness evaluation period
- Redo ablation failure, defined as:
1. Any LA repeat ablation procedure for recurrent AF/AFL/AT at any time during the effectiveness evaluation period
- Antiarrhythmic Drugs (AADs) failure, defined as:
1. Administering during the effectiveness evaluation period a previously failed Class I or III AAD at a dose greater than the highest ineffective historical dose (for Amiodarone, the historical maximum ineffective dose is the maintenance dose administered prior to the index ablation procedure)
2. Starting a new Class I or III AAD for AF during the effectiveness evaluation period
- Surgical treatment for AF/AFL/AT after the index procedure
Secondary Effectiveness Endpoints
The secondary effectiveness endpoints of this study are:
- Rate of treatment success evaluated at 24 months and 36 months following ablation
- Rate of subjects presenting with one or more device- or procedure-related serious adverse events through 12 months following ablation
- Rate of subjects who are free from AF/AFL/AT recurrence and off Class I and Class III antiarrhythmic drugs at 12-, 24-, and 36-months following ablation using the Globe PF System
- Proportion of subjects that experienced symptomatic AF/AFL/AT (episodes = 30 secs) during the effectiveness evaluation period
Primary Safety Endpoints:
Rate of subjects presenting with one or more primary safety events up to and including 7 days (or otherwise indicated) after the index ablation procedure. Primary safety events comprise the following device- or procedure-related serious adverse events:
- Death
- Cardiac tamponade/perforation
- Heart Block
- Major vascular access complication
- Major bleeding
- Myocardial infarction (MI)
- Pericarditis requiring intervention
- Pulmonary edema
- Stroke/cerebrovascular accident (CVA)
- Thromboembolism
- Transient ischemic attack (TIA)
- Vagal nerve injury resulting in gastroparesis
- Atrio-esophageal fistula (within 2 months of ablation procedure)
- Diaphragmatic paralysis/phrenic nerve injury (unresolved at 12 months)
- Severe PV stenosis (=70%, within 12 months of ablation procedure)
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| Follow-up Visits and Length of Follow-up |
The overall study duration for each subject is 36 months including follow-up visits at:
- Discharge
- 3-Month via a remote visit
- 6-, 12-, 24- and 36-Month via a remote visit or in-person
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