Clinical trial NCT04210622: An Initial Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System
Official title: An Initial Assessment of the Safety and Performance of the Sphere-9™ Catheter and System for Mapping and Ablation of Atrial Arrhythmias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Atrial Flutter
Lead sponsor: Medtronic Cardiac Ablation Solutions
Sponsor class: INDUSTRY
First posted: 2019-12-26
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective, single-arm, multi-center, safety and performance assessment of the Sphere-9™ Catheter and the Affera Mapping and Ablation System to treat Atrial Arrhythmias


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 and \< 75 years.
2. Suitable candidate for catheter non-emergent mapping and ablation of atrial flutter or atrial fibrillation as follows:

   • Atrial Flutter defined as

   o At least one episode of typical (clockwise or counterclockwise) atrial flutter documented by EKG, 12 lead EKG, Holter or transtelephonic monitor, telemetry strip, or implanted device within 6 months prior to enrollment.

   OR

   • Atrial Fibrillation defined as
   * History of symptomatic paroxysmal and/or persistent atrial fibrillation within the past year documented by EKG AND
   * Failure of at least one class I-IV drug as evidenced by recurrent symptomatic AF, or intolerable to AAD.
3. Subject is able and willing to give informed consent.
4. Subject is able and willing, and has ample means to comply with all pre-, post- and follow-up testing requirements.

Exclusion Criteria:

1. Documented left atrial thrombus or another abnormality which precludes catheter introduction.
2. Documented ejection fraction (EF) \< 40%.
3. Contraindication to anticoagulation therapy (heparin, warfarin, or novel oral anticoagulant \[NOAC\]).
4. Unstable angina or ongoing myocardial ischemia.
5. Myocardial infarction, unstable angina, cardiac surgery or coronary intervention within 3 months of enrollment.
6. Congenital heart disease where the underlying abnormality increases the risk of the ablation.
7. Pulmonary hypertension (mean pulmonary artery pressure \[mPAP\] \> 50 mmHg)
8. Enrollment in any other ongoing study protocol that would interfere with this study.
9. Documented severely impaired kidney function defined as Cockcroft-Gault Glomerular Filtration Rate (GFR) \< 29ml/min.
10. Active gastrointestinal (GI) bleeding.
11. Active infection or sepsis.
12. Short life expectancy (\< 1 year) due to illness such as cancer, pulmonary, hepatic or renal disease.
13. Significant anemia (defined as hemoglobin \< 8.0 gr/dL).
14. Severe uncontrolled systemic hypertension with systolic blood pressure (SBP) \> 200 mm Hg within last 30 days.
15. Severe bleeding, clotting or thrombotic disorder.
16. Uncontrolled diabetes.
17. Women who are pregnant or are not willing to use contraception for the duration of the study.
18. Severe chronic obstructive pulmonary disease (COPD; identified by a forced expiratory volume \[FEV1\] \<1)
19. Prior stroke or TIA within the last 6 months.
20. Any other condition that, in the opinion of the investigator, poses a significant hazard to the subject if an ablation procedure was performed.

    Additional exclusion criteria for AF patients only
21. Left atrial diameter of \> 55 mm (parasternal view).
22. Prior atrial septal defect (ASD) or patent foramen ovale (PFO) closure with a device using a transcatheter percutaneous approach.
23. Hypertrophic cardiomyopathy defined as left ventricular (LV) septal wall thickness \>1.5cm.
24. Prior ablation or surgery for atrial fibrillation.
25. NYHA Class III or IV

Primary outcomes:
measure: Number of Subjects With a Primary Safety Event
timeFrame: 90 days
measure: Number of Positive (Affirmative) Product Performance Responses
timeFrame: Index ablation procedure
Secondary outcomes:
measure: Number of Subjects Free From Documented Recurrence
timeFrame: 12 months
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital
Study officials:
References:
citation: Barkagan M, Leshem E, Rottmann M, Sroubek J, Shapira-Daniels A, Anter E. Expandable Lattice Electrode Ablation Catheter: A Novel Radiofrequency Platform Allowing High Current at Low Density for Rapid, Titratable, and Durable Lesions. Circ Arrhythm Electrophysiol. 2019 Apr;12(4):e007090. doi: 10.1161/CIRCEP.118.007090.
citation: Kitamura T, Hocini M, Bourier F, Martin R, Takigawa M, Frontera A, Thompson N, Cheniti G, Vlachos K, Martin CA, Lam A, Duchateau J, Pambrun T, Denis A, Sacher F, Derval N, Cochet H, Haissaguerre M, Jais P. Larger and deeper ventricular lesions using a novel expandable spherical monopolar irrigated radiofrequency ablation catheter. J Cardiovasc Electrophysiol. 2019 Sep;30(9):1644-1651. doi: 10.1111/jce.14089. Epub 2019 Aug 1.