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Procedure
Dispersion Ablation + PVI, VX1, PVI for Atrial Fibrillation (Tailored-AF Trial)
N/A
Waitlist Available
Research Sponsored by Volta Medical
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
Tailored-AF Trial Summary
This trial tests a new, tailored way of performing ablation for atrial fibrillation against the standard method.
Tailored-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
Freedom from documented AF after one ablation procedure
Secondary outcome measures
Freedom from documented AF/AT after one ablation procedure
Freedom from documented AF/AT after one or two ablation procedures
Incidence of complications (safety composite endpoint)
Tailored-AF Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TailoredExperimental Treatment2 Interventions
Tailored ablation strategy
Group II: AnatomicalActive Control1 Intervention
Anatomical ablation strategy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dispersion ablation + PVI
2021
N/A
~380
VX1
2021
N/A
~380
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Who is running the clinical trial?
Volta MedicalLead Sponsor
4 Previous Clinical Trials
682 Total Patients Enrolled
4 Trials studying Atrial Fibrillation
682 Patients Enrolled for Atrial Fibrillation
CardiaBaseOTHER
3 Previous Clinical Trials
1,141 Total Patients Enrolled
CovanceIndustry Sponsor
119 Previous Clinical Trials
12,441 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
28 Patients Enrolled for Atrial Fibrillation
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had short episodes of atrial fibrillation lasting less than 3 months.You have had long-term, ongoing atrial fibrillation for more than 5 years (or more than 1 year in the United States).You have tried and failed to restore normal heart rhythm at least two times when the duration of your atrial fibrillation was not known.You have had a surgery or a procedure called catheter ablation for atrial fibrillation (AF) in the past.You have had surgery on your atrioventricular valve before.You have very severe chronic heart failure.You have had unstable chest pain in the past month.You currently have a severe illness, widespread infection, or sepsis.You had a heart attack in the last 2 months.You have been diagnosed with atrial myxoma.You are 18 years or older and have never had a procedure to treat atrial fibrillation before.You have a type of irregular heartbeat (AF) that causes symptoms and doesn't get better with at least one antiarrhythmic medication.You have had atrial fibrillation for more than 3 months but less than 5 years.You have been taking blood thinners like warfarin or NOAC for more than 4 weeks before the procedure.You are extremely overweight with a BMI over 40.Your left atrium in your heart is very enlarged, as determined by a specific type of heart imaging called echocardiography.You are already taking part in a study testing a different device, treatment, or medication.You have a blockage, tumor, or other issue that makes it hard to use a catheter in your blood vessels.You have a medical condition that is likely to limit your life to less than 12 months.You currently have a positive test for Covid-19 and symptoms like fever or inflammation.You have atrial fibrillation caused by a reversible condition.You have a medical reason that makes taking blood-thinning medication unsafe.You have atrial fibrillation caused by problems with your body's electrolyte balance, thyroid, or other non-heart-related issues.At least 60% of the patients have had persistent atrial fibrillation for 6 months or longer, including at least 15% with long-standing persistent atrial fibrillation for 12 months or longer.Your blood thinning medication is not enough as specified in the inclusion criteria.You have a blood clot in your heart that was found on a special heart test before the procedure.You have a history of blood clots or bleeding problems.You have had a blood clot in an artery or a "mini-stroke" in the past year.You have rheumatic heart disease.You have a serious lung condition that causes ongoing breathing problems, such as chronic obstructive pulmonary disease (COPD) in its severe stage.
Research Study Groups:
This trial has the following groups:- Group 1: Tailored
- Group 2: Anatomical
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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