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Catheter Ablation
Mapping and Ablation for Atrial Fibrillation (SPHERE Per-AF Trial)
N/A
Waitlist Available
Research Sponsored by Affera, 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
SPHERE Per-AF Trial Summary
This trial is testing a new mapping and ablation catheter against a control device to see if the investigational device is more effective.
Who is the study for?
Adults aged 18-80 with persistent atrial fibrillation (AF) lasting more than 7 days but less than a year, who've had symptoms and failed or can't tolerate certain anti-arrhythmic drugs. They must be able to follow the study's procedures and give informed consent. Excluded are those with severe heart conditions, recent strokes or surgeries, pregnant women, and individuals with other major health issues.Check my eligibility
What is being tested?
The trial is testing two different catheter ablation tools for treating AF: the investigational Sphere-9 Catheter with Affera System versus the control THERMOCOOL SMARTTOUCH® SF catheter. Participants will be randomly assigned in equal numbers to either treatment group.See study design
What are the potential side effects?
Possible side effects from catheter ablation may include discomfort at the access site, bleeding, heart rhythm problems, blood vessel complications, and rarely more serious heart or lung issues.
SPHERE Per-AF Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent of subjects free from primary effectiveness failure
Percent of subjects with a primary adverse event
Secondary outcome measures
Energy application time
Procedure time
Treatment time
SPHERE Per-AF Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Sphere-9 CatheterExperimental Treatment1 Intervention
Sphere-9™ Mapping and Ablation Catheter; Affera Mapping System; Affera Ablation System
Group II: THERMOCOOL SMARTTOUCH SFActive Control1 Intervention
THERMOCOOL SMARTTOUCH® SF Catheter; SMARTABLATE® System; CARTO® 3 System
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mapping and Ablation
2021
N/A
~480
Find a Location
Who is running the clinical trial?
Affera, Inc.Lead Sponsor
2 Previous Clinical Trials
100 Total Patients Enrolled
2 Trials studying Atrial Fibrillation
100 Patients Enrolled for Atrial Fibrillation
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 80 years old.I have had symptoms of persistent atrial fibrillation for 7 days to less than 12 months, confirmed by tests.I have had severe acid reflux that needed surgery or a device to manage.I have tried and cannot tolerate or did not respond to a heart rhythm medication.I am a good candidate for a procedure to correct heart rhythm.I cannot have catheters placed due to a blockage or abnormality in my blood vessels.I have unstable chest pain.I had a heart bypass surgery within the last 6 months.I have had a procedure done on the left side of my heart.I have a serious lung condition that affects my breathing.I am scheduled for a heart transplant or surgery within a year after my first ablation.I have severe leakage in my heart's mitral valve.I have had a procedure to open or clean my carotid artery.I have had symptoms of AF for more than 7 days but less than a year, confirmed by tests.I do not have severe or uncontrolled heart failure.I have rheumatic heart disease.I have a significant narrowing of my heart's mitral valve.You are willing and able to comply with all baseline and follow-up evaluations for the full length of the study.I do not have any current infections or severe illnesses.My atrial fibrillation is due to a temporary condition like an electrolyte imbalance or thyroid issue.I have a history of unusual bleeding or clotting.I am on dialysis for kidney failure.I have not had a heart attack in the last 3 months.I am a good candidate for a procedure to correct heart rhythm.I have not had any heart procedures in the last 90 days.I have had heart valve surgery.I have high blood pressure in the lungs.I have had atrial fibrillation continuously for a year or more.I have tried and cannot tolerate or did not respond to a heart rhythm medication.I am between 18 and 80 years old.I cannot take blood thinners for a long time due to a health condition.I have been diagnosed with thickened heart muscles.I have been diagnosed with atrial myxoma.
Research Study Groups:
This trial has the following groups:- Group 1: Sphere-9 Catheter
- Group 2: THERMOCOOL SMARTTOUCH SF
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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