Pulsed Field Ablation (PFA) using the Centauri System for Atrial Fibrillation (SPACE AF Trial)

N/A

Waitlist Available

Research Sponsored by Galaxy Medical, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

SPACE AF Trial Summary

This trial will study the safety and performance of a new device to treat atrial fibrillation. The device will be used on patients who are indicated for a first-time catheter ablation of AF. The study will follow patients for 1 year.

SPACE AF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acute Procedural Success

Chronic Success

Device and Procedure related serious adverse event rate

SPACE AF Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

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Who is running the clinical trial?

Galaxy Medical, Inc.Lead Sponsor

1 Previous Clinical Trials

200 Total Patients Enrolled

1 Trials studying Atrial Fibrillation

200 Patients Enrolled for Atrial Fibrillation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are any participants being accepted for this experiment at the current time?

"According to clinicaltrials.gov, the recruitment for this trial has been paused since August 18th 2022. Despite this setback, there are 477 other trials actively seeking patients right now."

Answered by AI

Does the age range for this research extend to elderly participants?

"Data from the inclusion criteria reveals that suitable candidates must range in age between 18 and 75. In comparison, there are 11 trials dedicated to minors under 18 years old as well as 474 trials accommodating seniors aged 65 or older."

Answered by AI

Who would be an appropriate candidate for this research project?

"This medical trial is seeking 15 individuals with atrial fibrillation aged 18 to 75 years old. In order to be eligible, the following criteria must be met: documented failure of one or more antiarrhythmic drugs (AAD) due to recurrent symptomatic AF or side effects; physician's note indicating symptoms consistent with recurrent paroxysmal AF and documentation of two episodes within 12 months prior to enrollment by ECG, Holter monitor etc.; for persistent AF, 24-hour continuous ECG recording documenting this condition that occurred in the past 6 months OR two ECGs from any form rhythm monitoring taken 7 days apart in a"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety & Performance of the Centauri System for Patients With Atrial Fibrillation

2021. "Safety & Performance of the Centauri System for Patients With Atrial Fibrillation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04652778.