Trial Outcomes & Findings for Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System for Treatment of Atrial and Ventricular Arrhythmias (NCT NCT04211441)
NCT ID: NCT04211441
Last Updated: 2025-05-16
Results Overview
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.
COMPLETED
NA
74 participants
90 days
2025-05-16
Participant Flow
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.
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
74
|
|
Overall Study
COMPLETED
|
61
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Sphere-9™ Catheter
n=69 Participants
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
|
|---|---|
|
Age, Continuous
|
63.2 years
STANDARD_DEVIATION 9.4 • n=69 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=69 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=69 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: Subjects who underwent a procedure with the investigational device
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.
Outcome measures
| Measure |
Sphere-9™ Catheter
n=69 Participants
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
|
|---|---|
|
Percentage of Subjects With a Primary Safety Event
|
2 Participants
|
PRIMARY outcome
Timeframe: Index ablation procedurePopulation: All ablation procedures using the investigational device
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
Outcome measures
| Measure |
Sphere-9™ Catheter
n=69 Participants
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
|
|---|---|
|
Number of Positive (Affirmative) Product Performance Responses
|
69 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Subjects treated for AF
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.
Outcome measures
| Measure |
Sphere-9™ Catheter
n=20 Participants
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
|
|---|---|
|
Percentage of Subjects Free From Documented Recurrence
|
19 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Subset of subjects treated for AF underwent a remapping procedure to assess durability
* 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.
Outcome measures
| Measure |
Sphere-9™ Catheter
n=19 Participants
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
|
|---|---|
|
Number of Patients With Durable Ablation Lesions at Remapping Procedure
|
19 Participants
|
Adverse Events
Sphere-9™ Catheter
Serious adverse events
| Measure |
Sphere-9™ Catheter
n=69 participants at risk
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
|
|---|---|
|
Cardiac disorders
Pericarditis
|
1.4%
1/69 • Number of events 1 • Up to 12 months
|
|
Skin and subcutaneous tissue disorders
Esophogeal thermal injury
|
1.4%
1/69 • Number of events 1 • Up to 12 months
|
|
Infections and infestations
Septic Shock
|
1.4%
1/69 • Number of events 1 • Up to 12 months
|
|
Nervous system disorders
Diaphragmatic paralysis
|
1.4%
1/69 • Number of events 1 • Up to 12 months
|
|
Nervous system disorders
Cerebrovascular accident
|
1.4%
1/69 • Number of events 1 • Up to 12 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60