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
About the study: MANIFEST-US
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.
Key findings : MANIFEST-US
0.63%
The major adverse event rate* was 0.63% with no reports of esophageal fistula, pulmonary vein stenosis, or persistent phrenic nerve injury.
*Due to the retrospective nature of the registry, the adverse event rate was not reported at a pre-specified timepoint.
Design and methods: MANIFEST-US
- Center-level data was collected from 102 centers and 500+ US operators
- 41,968 total patients (37% PersAF)
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%)
- Low rates of hemolysis requiring hemodialysis (0.02%)
- Low rates of coronary spasm (0.1%)
- Low rates of vascular access complications requiring intervention (0.18%)
About the study: MANIFEST-17K
MANIFEST-17K multicenter registry1 was a retrospective observational study of the real-world commercial use of the FARAWAVE PFA Catheter.
Key findings: MANIFEST-17K
<1%
The major event rate was less than 1% with no reports of esophageal fistula or dysmotility, pulmonary vein stenosis, or persistent phrenic nerve injury.
Design and methods: MANIFEST 17-K
- Center-level data was collected from 106 centers and 413 operators (91.4% of all commerical centers used FARAPULSE PFA)
- 17,642 total patients (35% PersAF)
- Results reflect a 2-year window of patients treated (03/2021-03/2023)
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. There were 3 reports of generalized spasm (0.02%) which is lower than the cited thermal (RFA/CBA) rate of 0.19%.
- Hemolysis resulting in acute renal failure was rare, managed with hydration and associated with a high number of lesions applied.
Evidence of learning curve at both the physician/site level and within the EP community was seen in the significant decrease in rates of pericardial tamponade and minor vascular complications and improvements in stroke and transient phrenic nerve paresis rates from the initial MANIFEST-PF registry to MANIFEST-17K.
