NCT04210622

An Initial Assessment of the Sphere-9™ Catheter and Affera Mapping and Ablation System

Completed Results posted Last updated 16 May 2025

What this trial tests

trial testing Catheter mapping and ablation with the Sphere-9 Catheter and Affera Mapping and Ablation System in Atrial Fibrillation in 16 participants. Completed in 18 June 2020.

Timeline

1 May 2018

Primary endpoint
4 July 2019

18 June 2020

Quick facts

Lead sponsor	Medtronic Cardiac Ablation Solutions
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	1 May 2018
Primary completion	4 July 2019
Estimated completion	18 June 2020
Sites	1 location across Lithuania

Drugs / interventions tested

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

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →
• Atrial Flutter — all drugs for Atrial Flutter →

Sponsor

Medtronic Cardiac Ablation Solutions — full company profile →

Who can join

Adults 18 to 75, any sex, with Atrial Fibrillation or Atrial Flutter. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Subjects With a Primary Safety Event Primary · 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 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

Group	Value	95% CI
Sphere-9™ Catheter	0

Number of Positive (Affirmative) Product Performance Responses Primary · Index ablation procedure

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

Group	Value	95% CI
Sphere-9™ Catheter	16

Number of Subjects Free From Documented Recurrence Secondary · 12 months

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.

Group	Value	95% CI
Sphere-9™ Catheter	16

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.