Health TrialsbyHealthPanel

Sphere-9 PAF China Study

ConditionParoxysmal Atrial Fibrillation (PAF)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorMedtronic Cardiac Ablation Solutions

About this trial

The goal of this clinical trial is to find out if the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System is safe and works to treat recurrent symptomatic paroxysmal atrial fibrillation (PAF) in adults who have not been helped by, cannot tolerate, or cannot take certain medicines for PAF.

The main questions it aims to answer are:

Is the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System safe for treating PAF? Does the treatment help keep patients free from atrial fibrillation and other abnormal heart rhythms during the 12 months after the procedure?

Participants will:

Have their heart rhythm assessed before and after the ablation procedure. Have PAF treated using the Sphere-9 Catheter and Affera Integrated Mapping and Ablation System.

Have follow-up visits at 3, 6, and 12 months after the procedure.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

a physician's note indicating at least 2 symptomatic PAF episodes occurring within 6 months prior to enrollment; and

at least 1 electrocardiographically documented episode within 12 months prior to enrollment

Adults who are ≥18 and ≤80 years of age on the day of enrollment.

Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.

Disqualifiers

Continuous AF lasting more than 7 days. This includes persistent atrial fibrillation (PsAF) (both early or long-standing) by diagnosis or continuous duration > 7 days

AF that required three (3) or more distinct cardioversions in the preceding 12 months.

LA anteroposterior > 5.0 cm (by MRI, CT, or TTE)

Any of the following procedures, implants, or conditions at baseline: prior left atrial catheter or surgical ablation, prior left atrial percutaneous interventions including left atrial appendage occlusion, and septal closure devices

Trial design

Design model

Single group

Treatments tested in this trial

  • Catheter ablation using Sphere-9™ Catheter and Affera™ Integrated Mapping and Ablation System

    Device

    Pulsed field catheter ablation for pulmonary vain isolation.

Treatment groups

180 Participants
are divided into 1 treatment group
Group A: Participants receive treatment with the investigational devicesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary safety endpoint: Freedom from Device- and/or Procedure-Related Serious Adverse Events Through 6 Months Post-Ablation

The proportion of participants who are free from device- and/or procedure-related serious adverse events through 6 months after the ablation procedure.

Time frame
Through 6 months post-ablation
2

Primary effectiveness endpoint: Treatment Success at 12 Months Post-Ablation

The proportion of participants achieving treatment success (freedom from documented recurrence of AF, AT, or AFL based on electrocardiographic data) at 12 months after the ablation procedure and excluding a 90-day blanking period.

Time frame
12 months post-ablation

Secondary outcomes

1

Change in Atrial Fibrillation Effect on Quality-of-Life (AFEQT) questionnaires score from baseline through 12 months after the index ablation procedure

Change in AFEQT score from baseline to 12 months after the index ablation procedure. The AFEQT questionnaire assesses the impact of atrial fibrillation on a participant's quality of life. The overall score ranges from 0 to 100, with higher scores indicating better quality of life.

Time frame
Baseline through 12 months after the index ablation
2

Change in EuroQol Five-Dimensional Questionnaire (EQ-5D-5L) composite score from baseline through 12 months after the index ablation procedure

Change in EQ-5D-5L composite score from baseline to 12 months after the index ablation procedure. The EQ-5D-5L Questionnaire is a standardized instrument for measuring health status. The Chinese EQ-5D-5L value set will be used to calculate the composite score. The composite score ranges from -0.391 to 1, with higher scores indicating better health status.

Time frame
Baseline through 12 months after the index ablation procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medtronic Cardiac Ablation Solutions

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: