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Studies

Interventional Recruiting

NCT07298473 on ClinicalTrials.gov

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)

  • Sponsor: Medtronic (Group)
  • Enrollment: 400 (Estimated)
  • Study start: 2026-04-08 (Actual)
  • Primary completion: 2028-03-29 (Estimated)
  • Study completion: 2028-03-29 (Estimated)
  • Allocation: N/a
  • InterventionModel: Single Group
  • InterventionModelDescription: This is a prospective, multi-center, single-arm study in which all enrolled participants undergo a redo atrial fibrillation ablation using the Sphere-9 Catheter and Affera Ablation System. There is no randomization or control groups. All subjects who have the Sphere-9â„¢ Catheter inserted into the vasculature are included in the Primary Analysis Group. Subjects who exit the study prior to catheter insertion are classified as non-treated and are not included in the primary analysis.
  • Masking: None
  • PrimaryPurpose: Treatment

Brief 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)

Intervention / Treatment

  • Device: Sphere-9 Catheter Ablation

Primary Outcome Measures

  • Effectiveness: Number of Participants With Treatment Success. (12-months post-redo ablation procedure)
    Treatment success is defined to be freedom from treatment failure. The study requires 24-hour Holter monitoring at 6 and 12 months, weekly and symptomatic patient activated TTM transmissions through 12 months, and 12-lead ECGs or TTMs at all follow up visits. Treatment failure is defined as any of the following components: * Inability to successfully complete the study index redo ablation procedure utilizing the Sphere-9 Catheter and Affera Ablation System exclusively * Documented AF/AT/AFL after the 90-day post-ablation blanking period * Any subsequent catheter or surgical ablation, for recurrent AF/AT/AFL including repeat redo ablation at any time during the study * Direct current or pharmacological cardioversion for AF/AT/AFL recurrences after the 90-day blanking period (See section 9.11) * Use of a Class I or III AAD at a higher daily dose than the pre-ablation maximum dose after the 90-day blanking period and on or before day 365. * Initiation of a new Class I or III AAD after t
  • Safety: Number of Participants With at Least One Primary Safety Event (6-months post-redo ablation procedure)
    Primary safety events include: * 7 days of post-ablation: AKI requiring dialysis, new hospitalization \>48 hours, or prolongation of hospitalization \>48 hours beyond expected discharge, Death, Heart block requiring pacemaker, Major bleeding requiring transfusion, MI, Permanent phrenic nerve paralysis, Pulmonary edema, Severe pericarditis, Significant pericardial effusion/tamponade, Stroke/CVA, Systemic/pulmonary embolism requiring intervention, TIA, Vagal nerve injury resulting in esophageal dysmotility or gastroparesis, Vascular access complications requiring intervention, Any Sphere-9 Catheter or Affera Mapping \& Ablation System device- or procedure-related cardiovascular and/or pulmonary AE that prolongs or requires hospitalization \>48 hours (excl recurrent AF/AT/AFL) * 3 months post-ablation: Atrioesophageal fistula/esophago-pericardial fistula, Esophageal perforation (procedure \& Sphere-9 Catheter related) * 6 months post-ablation: Pulmonary vein stenosis (≥70% diameter reduction)

Countries

Australia, Belgium, Czechia, France, Switzerland, United States

Locations and Investigators

  • University of Alabama at Birmingham (UAB) Hospital, Birmingham, United States (Recruiting)
    • Hugh Thomas McElderry
    • Hugh Thomas McElderry, MD (Principal Investigator)
  • Scripps Green Hospital, La Jolla, United States (Not yet recruiting)
    • Douglas Gibson
    • Douglas Gibson, MD (Principal Investigator)
  • Cedars Sinai Medical Center, Los Angeles, United States (Recruiting)
    • Michael Shehata
    • Michael Shehata, MD (Principal Investigator)
  • NCH Rooney Heart Institute, Naples, United States (Recruiting)
    • Dinesh Sharma
    • Dinesh Sharma, MD (Principal Investigator)
  • AdventHealth Cardiovascular Research Institute, Orlando, United States (Recruiting)
    • Usman Siddiqui
    • Usman Siddiqui, MD (Principal Investigator)
  • Piedmont Heart Institute, Atlanta, United States (Recruiting)
    • Sandeep Goyal
    • Sandeep Goyal, MD (Principal Investigator)
  • Memorial Health University Medical Center, Savannah, United States (Recruiting)
    • Todd Senn
    • Todd Senn, MD (Principal Investigator)
  • Massachusetts General Hospital, Boston, United States (Recruiting)
    • Moussa Mansour
    • Moussa Mansour, MD (Principal Investigator)
  • Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist), Kansas City, United States (Recruiting)
    • Dhanunjaya Lakkireddy
    • Dhanunjaya Lakkireddy, MD (Principal Investigator)
  • Northwell Health Lenox Hill Hospital, New Hyde Park, United States (Recruiting)
    • Haisam Ismail
    • Haisam Ismail, MD (Principal Investigator)
  • NYU Langone Health, New York, United States (Recruiting)
    • Larry Chinitz
    • Larry Chinitz, MD (Principal Investigator)
  • Montefiore Medical Center, The Bronx, United States (Recruiting)
    • Luigi Di Biase
    • Luigi Di Biase, MD (Principal Investigator)
  • Cleveland Clinic Foundation, Cleveland, United States (Recruiting)
    • Ayman Hussein
    • Ayman Hussein, MD (Principal Investigator)
  • OhioHealth Research and Innovation Institute (OHRI), Columbus, United States (Recruiting)
    • Anish Amin
    • Anish Amin, MD (Principal Investigator)
  • Hospital of the University of Pennsylvania, Philadelphia, United States (Recruiting)
    • Saman Nazarian
    • Saman Nazarian, MD (Principal Investigator)
  • Allegheny General Hospital, Pittsburgh, United States (Recruiting)
    • Amit Thosani
    • Amit Thosani, MD (Principal Investigator)
  • Vanderbilt University Medical Center, Nashville, United States (Recruiting)
    • Zachary Yoneda
    • Zachary Yoneda, MD (Principal Investigator)
  • Texas Cardiac Arrhythmia Research Foundation, Dallas, United States (Recruiting)
    • Andrea Natale
    • Andrea Natale, MD (Principal Investigator)
  • Texas Health Fort Worth, Fort Worth, United States (Recruiting)
    • Theodore Takata
    • Theodore Takata, MD (Principal Investigator)
  • Inova Fairfax Hospital, Falls Church, United States (Recruiting)
    • Stephen Gaeta
    • Stephen Gaeta, MD (Principal Investigator)
  • Centra Medical Group Stroobants Cardiovascular Center, Lynchburg, United States (Recruiting)
    • Chinmaya Mareddy
    • Chinmaya Mareddy, MD (Principal Investigator)
  • Sentara Norfolk General Hospital, Newport News, United States (Recruiting)
    • Venkat Iyer
    • Venkat Iyer, MD (Principal Investigator)
  • Westmead Hospital, Westmead, Australia (Recruiting)
    • Stuart Thomas
    • Stuart Thomas, MD (Principal Investigator)
  • Adelaide University, Adelaide, Australia (Recruiting)
    • Prashanthan Sanders
    • Sanders Prashanthan, MD (Principal Investigator)
  • The Royal Melbourne Hospital, Parkville, Australia (Recruiting)
    • Jonathan M Kalman
    • Jonathan M Kalman, MD (Principal Investigator)
  • Universitair Ziekenhuis Brussel, Brussels, Belgium (Not yet recruiting)
    • Andrea Sarkozy
    • Andrea Sarkozy, MD (Principal Investigator)
  • IKEM - Institut Klinické a Experimentální Medicíny, Prague, Czechia (Not yet recruiting)
    • Josef Kautzner
    • Josef Kautzner, MD (Principal Investigator)
  • Motol and Homolka University Hospital, Prague, Czechia (Not yet recruiting)
    • Petr Neuzil
    • Petr Neuzil, MD (Principal Investigator)
  • Clinique Pasteur, Toulouse, France (Not yet recruiting)
    • Jean-Paul Albenque
    • Jean-Paul Albenque, MD (Principal Investigator)
  • Inselspital - Universitätsspital Bern, Bern, Switzerland (Not yet recruiting)
    • Tobias Reichlin
    • Tobias Reichlin, MD (Principal Investigator)

Study Officials

  • Khaldoun Tarakji, MD (Study Director) — Medtronic