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| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P230030 S012/ PAS001 |
| Date Original Protocol Accepted |
08/06/2026
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| Date Current Protocol Accepted |
08/06/2026
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| Study Name |
FAR-AHEAD Study
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| Device Name |
FARAPULSE™ Pulsed Field Ablation System (FARAWAVE™ Pulsed Field Ablation Catheter, FARAWAVE™ NAV Pulsed Field Ablation Catheter, FARAPOINT™ Pulsed Field Ablation Catheter, FARASTAR™ Catheter Connection Cable, FARASTAR™ Pulsed Field Ablation Generator, FARASTAR™ Recording System Module, FARASTAR™ Mapping System Module, FARASTAR™ Stimulation Module Cable, FARASTAR™ EGM Cable, FARASTAR™ Stimulation Module Male Cable, FARASTAR™ Stimulation Module Female Cable, FARASTAR™ Stimulation Module Y-Cable Long, FARASTAR™ Stimulation Module Y-Cable Short, FARASTAR™ Recording System Module Catheter Pin Cable, FARASTAR™ Recording System Module ECG Trunk Cable, FARASTAR™ Recording System Module ECG Output Module (AAMI/IEC), FARASTAR™ Recording System Module EGM Input Module, FARASTAR™ SNAP CABLE R/L – (AAMI/IEC), FARASTAR™ SNAP CABLE V SET – (AAMI), FARASTAR™ SNAP CABLE C SET – (IEC), FARASTAR™ Recording System Module ECG Output to Rhythmia HDx™ ECG Input Cable, FARASTAR™ Recording System Module EGM Ou
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| Clinical Trial Number(s) |
NCT05443594
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| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
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| Data Source |
New Data Collection
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Descriptive
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| Study Population |
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
To obtain real world clinical data on the safety and effectiveness of the FARAPOINT catheter for CTI ablation as an adjunctive treatment of drug-refractory, symptomatic PsAF (episode duration <1 year) in support of the following objectives:
4. Estimating the primary safety adverse event rate at 30 days following PsAF ablation procedure using the FARAWAVE™ Pulsed Field Ablation Catheter and the
FARAPOINT™ Pulsed Field Ablation Catheter.
5. Estimating the rate of chronic RCA stenosis (>= 50% obstruction) related to CTI ablation with the FARAPOINT™ Pulsed Field Ablation Catheter.
6. Estimating the rate of durable CTI conduction block following concomitant CTI ablation with the FARAPOINT™ Pulsed Field Ablation Catheter.
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| Sample Size |
Number of subjects: 265
Assumptions for sample size estimation: Ensure a very high probability (99%-99.5%) to detect at least one primary safety event (primary study objective #1), assuming an event rate of 2% based on results from ADVANTAGE AF Phase 2 FARAPOINT treatment subjects
Number of sites: 10
Sites location: TBA
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| Key Study Endpoints |
Data collection will include the following:
- Medical history and demographics
- Acute procedural details
- 30-day evaluation of primary safety
- 6- and 12-month rhythm monitoring for recurrence
- At least 60 PsAF subjects will undergo a baseline and 12-month post-procedure CTA to assess RCA stenosis
- Re-mapping data for patients undergoing redo during the 12-month follow-up to evaluate the durability of the CTI lesion
- 3-year post-discharge composite rate for acute coronary syndrome, new ischemic electrocardiogram (ECG) changes consistent with inferior ischemia requiring
treatment, hemodynamically significant coronary artery spasm requiring intracoronary nitroglycerin and/or causing ST-segment elevation, urgent coronary
angiography with an RCA culprit finding, and cardiac death
- 36 – month freedom from AF/AFL/AT recurrence from medical chart review
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| Follow-up Visits and Length of Follow-up |
Patients in FAR-AHEAD will be enrolled and followed for 36 months post-ablation.
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