MANIFEST multicenter registries overview
MANIFEST-17K multicenter registry1 was a retrospective observational study of the real-world commercial use of the FARAWAVE™ Pulsed Field Ablation (PFA) Catheter.
MANIFEST-US multicenter registry2 was a retrospective observational study of post-approval use in the US of the FARAWAVE PFA Catheter focused on 30-day safety and procedural characteristics.
- MANIFEST-US
- MANIFEST-17K
MANIFEST-US multicenter registry2 is a retrospective observational study of post-approval use in the US of the FARAWAVE™ Pulsed Field Ablation (PFA) Catheter focused on 30-day safety and procedural characteristics. Center-level data was collected across 102 US sites from more than 500 operators spanning February 2024 – July 2025.
Study design: Multicenter, retrospective, observational study
Patient population: 41,968 patients; most patients were de novo AF patients (73%) (first time ablation), undergoing ablation for paroxysmal AFib (54.0%) or persistent AFib (37.0%)
Key findings: MANIFEST-US
0.63%
major adverse event rate in nearly 42,000 patients
The major adverse event rate* was 0.63% with no reports of esophageal fistula, pulmonary vein stenosis, or persistent phrenic nerve injury.
The minor complication rate was 2.1% with a majority of events being vascular complications (0.96%) or pericarditis (0.52%).
*Due to the retrospective nature of the registry, the adverse event rate was not reported at a pre-specified timepoint.
Conclusions: MANIFEST-US
- This data expands beyond the MANIFEST-17K registry further validating the consistent, strong safety profile of FARAPULSE PFA in an everyday all-comer real-world clinical patient population.
- In nearly 42,000 patients treated across 102 centers by more than 500 operators, the FARAWAVE catheter demonstrated consistently low complication rates:
- 0.63% major adverse event rate
- 0 reported AE fistulas, PV stenosis or persistent phrenic nerve injury
- Low incidence of stroke (0.1%) and TIA (0.08%) within 7 days
- Low rates of acute renal failure requiring hemodialysis (0.02%)
- Low rates of coronary spasm (0.1%)
- Low rates of vascular access complications requiring intervention (0.18%)
MANIFEST-17K multicenter registry1 was a retrospective observational study of the real-world commercial use of the FARAWAVE PFA Catheter. Center-level data was collected across 106 EU sites and 413 operators spanning a 2-year period (3/2021-3/2023); 91.4% of commercial centers reported.
Study design: Multicenter, retrospective, observational study
Patient population: 17,642 drug-refractory paroxysmal AFib patients
Reported outcomes: Safety
Key findings: MANIFEST-17K
Clinicians worldwide have confirmed the safety of FARAPULSE.
reports of esophageal fistula or dysmotility, pulmonary vein stenosis, or persistent phrenic nerve injury
major adverse event rate with the most common complication being pericardial tamponade (0.36%)*
Low rates of pulsed field energy-specific adverse events
- 0.06% transient phrenic nerve paresis
- 0.14% coronary spasm
- 0.03% hemolysis/renal failure
Conclusions: MANIFEST-17K
- This data expands beyond the initial 24 centers involved in the MANIFEST-PF3 registry, showing that the low rate of safety events continues as the technology is adopted by additional centers.
- One of the goals of this registry was to look for any unusual adverse events that would only occur after thousands of procedures. Two rare events were noted: coronary spasm and hemolysis.
- The rate of coronary spasm was 0.14% with a majority (88%) being proximity related occurring with off-label use of the catheter during mitral isthmus MI or CTI ablation.
- Hemolysis resulting in acute renal failure was rare, managed with hydration and associated with a high number of lesions applied.
Next: See how FARAPULSE PFA compared to thermal ablation
References:
1. Ekanem, E., Neuzil, P., Reichlin, T. et al. Safety of pulsed field ablation in more than 17,000 patients with atrial fibrillation in the MANIFEST-17K study. Nat Med (2024) https://doi.org/10.1038/s41591-024-03114-3
2. Turagam, Mohit K., et al. "Multicenter Study on the Safety of Pulsed Field Ablation in Over 40,000 Patients: MANIFEST-US." JACC (2025)
3. Ekanem, Emmanuel, et al. "Multi-national survey on the methods, efficacy, and safety on the post-approval clinical use of pulsed field ablation (MANIFEST-PF)." Europace 24.8 (2022): 1256-1266