Key Highlights

Risk & Performance

Pipeline Risk Assessment

Based on historical performance

Low Risk

Score: 25/100

Failure Rate

5.7%

2 terminated/withdrawn out of 35 trials

Success Rate

90.9%

+4.4% vs industry average

Late-Stage Pipeline

2 trials in Phase 3/4

Results Transparency

80%

16 of 20 completed trials have results

Key Signals

10 recruiting16 with results

Enrollment Performance

Analytics

N/A

20(90.9%)

Phase 4

1(4.5%)

Phase 3

1(4.5%)

22Total

N/A(20)

Phase 4(1)

Phase 3(1)

Activity Timeline

Global Presence

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Clinical Trials (35)

Showing 20 of 35 trials

NCT07575828Not ApplicableNot Yet Recruiting

Outcomes of an Optimized Workflow With PulseSelect Pulsed Field Ablation (PFA) System in Paroxysmal and Persistent Atrial Fibrillation

Role: lead

NCT06858306Active Not Recruiting

SPHERE Per-AF Post-Approval Study

Role: lead

NCT07308847Not ApplicableRecruiting

Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)

Role: lead

NCT01490814Not ApplicableCompleted

FIRE AND ICE: Comparative Study of Two Ablation Procedures in Patients With Atrial Fibrillation

Role: lead

NCT07298473Not ApplicableRecruiting

Conquer-AF Protocol for Redo Ablation Procedures in Recurrent Paroxysmal and Persistent Atrial Fibrillation Using the Sphere-9 Catheter and Affera Ablation System (Conquer-AF)

Role: lead

NCT06578104Recruiting

PULSED AF Post-Approval Study

Role: lead

NCT06703489Not ApplicableRecruiting

Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS)

Role: lead

NCT05115214Not ApplicableRecruiting

Safety and Performance of the Affera SpherePVI™ Multi-Ablation System to Treat Paroxysmal Atrial Fibrillation

Role: lead

NCT05144503Not ApplicableRecruiting

Safety and Performance of the SpherePVI™ Catheter to Treat Paroxysmal Atrial Fibrillation

Role: lead

NCT06393920Recruiting

PulseSelect™ PFA Global Registry

Role: lead

NCT05230524Terminated

DIAMOND AF Post-Approval Study