Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System for Treatment of Atrial and Ventricular Arrhythmias

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-09-18

Brief Summary

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

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Detailed Description

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Conditions

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Atrial Fibrillation Atrial Flutter Ventricular Tachycardia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subjects who are treated with the Sphere-9™ Catheter

Group Type EXPERIMENTAL

Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System

Intervention Type DEVICE

Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System

Interventions

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Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

• Atrial Flutter (AFL) 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 (AF) 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 thrombus or another abnormality which precludes catheter introduction.
2. Documented ejection fraction (EF) \< 40% for AF and AFL, and EF \< 15% for VT.
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. Prior atrial septal defect (ASD) or patent foramen ovale (PFO) closure with a device using a transcatheter percutaneous approach.
21. Hypertrophic cardiomyopathy defined as left ventricular (LV) septal wall thickness \>1.5cm.
22. Any other condition that, in the opinion of the investigator, poses a significant hazard to the subject if an ablation procedure was performed.

23. Left atrial diameter of \>55 mm (parasternal view).
24. Prior ablation or surgery for atrial fibrillation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No