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)

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sphere-9 Catheter Ablation — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Apr 8, 2026

Status verified

Apr 2026

Primary completion

Mar 29, 2028

Completion

Mar 29, 2028

Study Design

Enrollment

400 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Single Arm: Redo AF Ablation with Sphere-9 Catheter
  Participants undergo a redo atrial fibrillation ablation using the Sphere-9 Catheter and the Affera Ablation System per study protocol. All subjects receive the same intervention with no control or comparator arm.

Primary Outcome Measure

Effectiveness: Number of Participants With Treatment Success. [ Time Frame: 12-months post-redo ablation procedure ]

Central Contacts

• Ryan S Radtke, Bachelors of Science- Biology
  712-941-9372
  [email protected]

Locations (22)

Find similar trials in Birmingham, AL

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