Trial Outcomes & Findings for An Initial Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System (NCT NCT04210622)

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 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.

Recruitment status

COMPLETED

Target enrollment

16 participants

Primary outcome timeframe

90 days

Results posted on

2025-05-16

Participant Flow

16 subjects were enrolled in the study, all of whom underwent the index ablation procedure. 7 subjects completed and exited the study at Day 90 per the informed consent. 9 subjects completed and exited the study at Day 365 per the informed consent.

Participant milestones

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	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sphere-9™ Catheter n=16 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	56.5 years STANDARD_DEVIATION 5.6 • n=16 Participants
Sex: Female, Male Female	3 Participants n=16 Participants
Sex: Female, Male Male	13 Participants n=16 Participants

PRIMARY outcome

Timeframe: 90 days

Population: Subjects who signed an informed consent and underwent an ablation procedure

The primary safety outcome is the rate of the following serious adverse events (SAEs) occurring starting Day 0 and extending through the Day 10 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

Outcome measures
Measure	Sphere-9™ Catheter n=16 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 Subjects With a Primary Safety Event	0 Participants

PRIMARY outcome

Timeframe: Index ablation procedure

Population: Procedures that were conducted with patients that provided informed consent.

The primary 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

Outcome measures
Measure	Sphere-9™ Catheter n=16 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	16 Participants

SECONDARY outcome

Timeframe: 12 months

Population: Subjects that signed consent and underwent an ablation procedure

The secondary product performance 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

Outcome measures
Measure	Sphere-9™ Catheter n=16 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 Subjects Free From Documented Recurrence	16 Participants

Adverse Events

Sphere-9™ Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Research Specialist

Medtronic, Inc

Phone: 800-328-2518

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60