Atrial Fibrillation, Atrial Flutter, Ventricular Tachycardia
Conditions
Brief summary
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
Interventions
DEVICECatheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System
Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System
Sponsors
Medtronic Cardiac Ablation Solutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With a Primary Safety Event | 90 days | The primary safety outcome is the rate of the following serious adverse events (SAEs) occurring starting Day 0 and extending through the Day 10 post-treatment assessment: transient ischemic attack; cerebrovascular accident; major bleeding; cardiac tamponade; pulmonary vein stenosis; severe pericarditis requiring extended hospitalization; myocardial infarction; diaphragmatic paralysis; atrio-esophageal fistula (through the Day 90 assessment) ; valvular damage; phrenic nerve palsy; intra-procedural device complications requiring open chest or heart surgery; vascular complications requiring surgical intervention; and death. |
| Number of Positive (Affirmative) Product Performance Responses | Index ablation procedure | The primary acute product performance outcome is determined during the procedure and is defined as the following: * Catheter handling sufficient to reach reasonable intended targets, as determined by the physician: * catheter delivery to the desired cardiac chambers * manipulation of catheter * completion of mapping procedure * safe removal of catheter from the subject * 3D electro-anatomical map creation and utility sufficient to aid diagnosis * Generation of acceptable acute therapeutic RF lesions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects Free From Documented Recurrence | 12 months | A secondary product effectiveness outcome is freedom from documented recurrence of the treated arrhythmia through the Day 365 post-treatment follow-up visit. In AF subjects, this includes freedom from documented AF, atrial tachycardia (AT), or AFL. |
| Number of Patients With Durable Ablation Lesions at Remapping Procedure | 3 months | * In AF subjects that are remapped, the number of pulmonary veins that remain isolated and the number of patients with all pulmonary veins isolated will be determined. * In all subjects that are remapped, the number of previously confirmed lines of block remaining isolated will be determined. |
Countries
Czechia
Participant flow
Pre-assignment details
74 subjects were enrolled in the study. Of these, five were excluded or withdrew prior to treatment with the study devices. 69 patients underwent the procedure.
Participants by arm
| Arm | Count |
|---|---|
| Sphere-9™ Catheter Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System: Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System | 69 |
| Total | 69 |
Baseline characteristics
| Characteristic | Sphere-9™ Catheter | — |
|---|---|---|
| Age, Continuous | 63.2 years STANDARD_DEVIATION 9.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 21 Participants | — |
| Sex: Female, Male Male | 48 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 69 |
| other Total, other adverse events | 0 / 69 |
| serious Total, serious adverse events | 5 / 69 |
Outcome results
Primary
Number of Positive (Affirmative) Product Performance Responses
The primary acute product performance outcome is determined during the procedure and is defined as the following: * Catheter handling sufficient to reach reasonable intended targets, as determined by the physician: * catheter delivery to the desired cardiac chambers * manipulation of catheter * completion of mapping procedure * safe removal of catheter from the subject * 3D electro-anatomical map creation and utility sufficient to aid diagnosis * Generation of acceptable acute therapeutic RF lesions
Time frame: Index ablation procedure
Population: All ablation procedures using the investigational device
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sphere-9™ Catheter | Number of Positive (Affirmative) Product Performance Responses | 69 Participants |
Primary
Percentage of Subjects With a Primary Safety Event
The primary safety outcome is the rate of the following serious adverse events (SAEs) occurring starting Day 0 and extending through the Day 10 post-treatment assessment: transient ischemic attack; cerebrovascular accident; major bleeding; cardiac tamponade; pulmonary vein stenosis; severe pericarditis requiring extended hospitalization; myocardial infarction; diaphragmatic paralysis; atrio-esophageal fistula (through the Day 90 assessment) ; valvular damage; phrenic nerve palsy; intra-procedural device complications requiring open chest or heart surgery; vascular complications requiring surgical intervention; and death.
Time frame: 90 days
Population: Subjects who underwent a procedure with the investigational device
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sphere-9™ Catheter | Percentage of Subjects With a Primary Safety Event | 2 Participants |
Secondary
Number of Patients With Durable Ablation Lesions at Remapping Procedure
* In AF subjects that are remapped, the number of pulmonary veins that remain isolated and the number of patients with all pulmonary veins isolated will be determined. * In all subjects that are remapped, the number of previously confirmed lines of block remaining isolated will be determined.
Time frame: 3 months
Population: Subset of subjects treated for AF underwent a remapping procedure to assess durability
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sphere-9™ Catheter | Number of Patients With Durable Ablation Lesions at Remapping Procedure | 19 Participants |
Secondary
Percentage of Subjects Free From Documented Recurrence
A secondary product effectiveness outcome is freedom from documented recurrence of the treated arrhythmia through the Day 365 post-treatment follow-up visit. In AF subjects, this includes freedom from documented AF, atrial tachycardia (AT), or AFL.
Time frame: 12 months
Population: Subjects treated for AF
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Sphere-9™ Catheter | Percentage of Subjects Free From Documented Recurrence | 19 Participants |