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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)

NCT07298473 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-04-13

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • Medtronic Cardiac Ablation Solutions

    lead INDUSTRY

Principal Investigators

  • Khaldoun Tarakji, MD · Medtronic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-08
Primary Completion
2028-03-29
Completion
2028-03-29
FDA Device
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Czechia
  • France
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07298473 on ClinicalTrials.gov