Recruiting
Not applicable
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)
Condition(s) studied
Atrial Fibrillation (AF)Persistent Atrial FibrillationParoxysmal Atrial Fibrillation (PAF)
Investigational drug(s) / intervention(s)
Sphere-9 Catheter Ablation
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.
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.
Eligibility
Inclusion Criteria:
* 1\. History of a single AF ablation procedure for PAF or PsAF within 3 years prior to enrollment 2. Documented evidence of symptomatic AF, AT or AFL recurrence at least 90 days after subject's de novo ablation procedure, as demonstrated by:
* A physicians' note indicating at least 1 symptomatic AF, AT, or AFL episode occurring within 12 months prior to the enrollment; and
* At least 1 electrocardiographically documented episode of AF, AT, or AFL within 12 months prior to enrollment 3. Adults who are ≥18 years of age on the day of enrollment 4. Willing and able to comply with all study requirements and provide informed consent
Exclusion Criteria:
* 1\. Continuous AF lasting for 12 months or longer 2. LA anteroposterior \>55 mm (by MRI, CT, or TTE), or if LA diameter not available, non-index volume \>100 mL for PsAF subjects; OR LA anteroposterior \>50 mm (by MRI, CT, or TTE), or if LA diameter not available, non-index volume \>95 mL for PAF subjects 3. Previous left atrial percutaneous interventions including left atrial appendage occlusion and septal closure devices 4. Planned left atrial appendage (LAA) closure procedure, cardiac transplantation or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period 5. More than 1 previous AF ablation procedure 6. Any prior surgical ablation procedure 7. Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure 8. Contraindication to or unwillingness to use systemic anticoagulation 9. Severe thrombocytosis, thrombocytopenia, or any bleeding or clotting disorder 10. Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) 11. Presence of any pulmonary vein stents 12. Known pre-existing pulmonary vein stenosis 13. Pre-existing hemidiaphragmatic paralysis 14. Prior valvular (surgical or percutaneous) procedure including prosthetic, bioprosthetic, valve replacement, valve repair or valvuloplasty, or any prior atriotomy 15. Moderate to severe mitral valve or aortic stenosis 16. Moderate to severe mitral regurgitation (i.e., 3+ or 4+ MR) 17. Any cardiac surgery, myocardial infarction, PCI/PTCA or coronary artery stenting which occurred within the 3 months preceding the consent date 18. NYHA Class III or IV congestive heart failure 19. Documented left ventricular ejection fraction (LVEF) ≤40%, measured by acceptable cardiac testing (e.g., TTE) 20. Unstable angina 21. Severe lung disease, primary pulmonary hypertension, or any lung disease requiring supplemental oxygen 22. Rheumatic heart disease 23. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition 24. Presence of left atrial thrombus on imaging 25. Active systemic infection or sepsis 26. Hypertrophic cardiomyopathy 27. Amyloid heart disease 28. Diagnosed atrial myxoma 29. Known reversible causes of AF (e.g., uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, acute alcohol toxicity or other reversible or non-cardiac cause) 30. Any cerebral ischemic event (strokes or TIAs) which occurred within the preceding 6 months of the consent date through the date of study index redo ablation procedure 31. Carotid stenting or endarterectomy 32. Thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure 33. Body mass index \> 40 kg/m2 34. Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence\* 35. Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed 36. Current or anticipated participation in any other clinical study of a drug, device or biologic during the duration of the study not pre-approved by Medtronic 37. Renal insufficiency with an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m2, or any history of renal failure requiring dialysis or renal transplant 38. Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation 39. Presence of an inferior vena cava (IVC) filter (e.g., Greenfield or similar) that would preclude safe transfemoral venous access, catheter passage, or sheath manipulation.
40\. Known drug or alcohol dependency 41. Significant congenital anomaly or medical problem that would, in the opinion of the investigator, preclude enrollment, follow-up compliance, or the scientific integrity of the study
\*Women who are of child-bearing potential must undergo a pregnancy test after consent and prior to the study index redo ablation procedure, as allowed according to local regulations
Primary outcome measure(s)
- 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)
Trial sites (30)
| Facility | City | Region | Status |
| University of Alabama at Birmingham (UAB) Hospital |
Birmingham |
Alabama |
Recruiting |
| Scripps Green Hospital |
La Jolla |
California |
Not Yet Recruiting |
| Cedars Sinai Medical Center |
Los Angeles |
California |
Recruiting |
| NCH Rooney Heart Institute |
Naples |
Florida |
Recruiting |
| AdventHealth Cardiovascular Research Institute |
Orlando |
Florida |
Not Yet Recruiting |
| Piedmont Heart Institute |
Atlanta |
Georgia |
Recruiting |
| Memorial Health University Medical Center |
Savannah |
Georgia |
Recruiting |
| Massachusetts General Hospital |
Boston |
Massachusetts |
Recruiting |
| Kansas City Heart Rhythm Institute (Midwest Heart and Vascular Specialist) |
Kansas City |
Missouri |
Not Yet Recruiting |
| Northwell Health Lenox Hill Hospital |
New Hyde Park |
New York |
Recruiting |
| NYU Langone Health |
New York |
New York |
Recruiting |
| Montefiore Medical Center |
The Bronx |
New York |
Recruiting |
| Cleveland Clinic Foundation |
Cleveland |
Ohio |
Recruiting |
| OhioHealth Research and Innovation Institute (OHRI) |
Columbus |
Ohio |
Recruiting |
| Hospital of the University of Pennsylvania |
Philadelphia |
Pennsylvania |
Recruiting |
| Allegheny General Hospital |
Pittsburgh |
Pennsylvania |
Recruiting |
| Vanderbilt University Medical Center |
Nashville |
Tennessee |
Recruiting |
| Texas Cardiac Arrhythmia Research Foundation |
Dallas |
Texas |
Recruiting |
| Texas Health Fort Worth |
Fort Worth |
Texas |
Recruiting |
| Inova Fairfax Hospital |
Falls Church |
Virginia |
Recruiting |
| Centra Medical Group Stroobants Cardiovascular Center |
Lynchburg |
Virginia |
Recruiting |
| Sentara Norfolk General Hospital |
Newport News |
Virginia |
Recruiting |
| Westmead Hospital |
Westmead |
New South Wales |
Recruiting |
| Adelaide University |
Adelaide |
South Australia |
Recruiting |
| The Royal Melbourne Hospital |
Parkville |
Victoria |
Recruiting |
| Universitair Ziekenhuis Brussel |
Brussels |
Belgium |
Not Yet Recruiting |
| IKEM - Institut Klinické a Experimentální Medicíny |
Prague |
Czechia |
Not Yet Recruiting |
| Motol and Homolka University Hospital |
Prague |
Czechia |
Not Yet Recruiting |
| Clinique Pasteur |
Toulouse |
France |
Not Yet Recruiting |
| Inselspital - Universitätsspital Bern |
Bern |
Switzerland |
Not Yet Recruiting |