NCT07298473

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Medtronic Cardiac Ablation Solutions · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Conquer-AF is a prospective, multi-center, interventional, non-randomized clinical study that will enroll up to 400 subjects at up to 30 sites across the United States, Europe, and Australia. Subjects diagnosed with symptomatic recurrent paroxysmal or persistent atrial fibrillation after a single prior ablation procedure will be enrolled in this study. Each subject will undergo a study index redo ablation procedure using the Sphere-9 Catheter and Affera Ablation System and will be followed for 12 months. The expected total study duration (from time of first enrollment to the exit of last enrolled subject) is approximately 2 years.

Detailed description

The Conquer-AF study is a prospective, multi-center, interventional, non-randomized clinical study to evaluate the safety and effectiveness of the Sphere-9 Catheter and Affera Ablation System, when used in conjunction with the Affera Mapping System or Affera Integrated Mapping System, in patients undergoing redo ablation for symptomatic recurrent paroxysmal or persistent atrial fibrillation following a single prior ablation procedure. This study will enroll up to 400 subjects diagnosed with symptomatic recurrent PAF and PsAF and will be conducted at up to 30 study sites located across the United States, Europe, and Australia. No single site may enroll more than 60 (with no more than 37 in either cohort) subjects to ensure a reasonable distribution of subjects across sites. Adult subjects with symptomatic recurrent PAF and PsAF will undergo a study index redo ablation procedure with the Sphere-9 Catheter and Affera Ablation System. Following the study index redo ablation procedure and hospital discharge, all study subjects will be followed at 7 days, 3 months, 6 months, and 12 months post-procedure. Subjects will be exited from the study at the conclusion of the 12-month follow-up visit and associated 24-hour Holter. The expected total study duration is approximately 2 years, representing approximately 12 months of enrollment and 12 months of subject follow-up. Treated subjects will not be replaced with newly enrolled subjects upon early study exit.

Conditions

• Atrial Fibrillation (AF)
• Persistent Atrial Fibrillation
• Paroxysmal Atrial Fibrillation (PAF)

Interventions

Type	Name	Description
DEVICE	Sphere-9 Catheter Ablation	Redo atrial fibrillation ablation performed using the Sphere-9 Catheter in conjunction with the Affera Ablation System and Affera Mapping System. The intervention delivers radiofrequency and pulsed field energy according to the study protocol for treatment of recurrent paroxysmal or persistent AF. All participants receive this device-based ablation procedure.

Timeline

• Start date: 2026-04-08
• Primary completion: 2028-03-29
• Completion: 2028-03-29
• First posted: 2025-12-23
• Last updated: 2026-04-13

Locations

30 sites across 6 countries: United States, Australia, Belgium, Czechia, France, Switzerland

Regulatory

• FDA-regulated device study