HeartLight Ablation for Atrial Fibrillation

N/A

Recruiting

Research Sponsored by CardioFocus

Eligibility Criteria Checklist

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

Must have

18 years or older

planned for catheter ablation due to symptomatic paroxysmal atrial fibrillation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months and 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will look at how well the HeartLight System works in the real world.

Who is the study for?

This trial is for adults over 18 who have atrial fibrillation, a type of irregular heartbeat. They should have tried at least one anti-arrhythmic drug that didn't work and are now planning to undergo catheter ablation because their heart condition causes symptoms.

What is being tested?

The study is looking at the HeartLight System's performance in real-world medical use. It follows up on previous research by monitoring how well it works when doctors treat patients with this device after it has been approved for use.

What are the potential side effects?

While specific side effects aren't listed here, typical risks associated with ablation procedures include bleeding or infection at the catheter insertion site, damage to blood vessels or heart tissue, and potential arrhythmias.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am scheduled for a procedure to treat irregular heartbeats.

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I have tried at least one medication for irregular heartbeats without success.

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This criterion does not apply to my situation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months and 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months and 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The proportion of participants free from symptomatic atrial fibrillation (AF) or symptomatic atypical atrial flutter/atrial tachycardia (AFL/AT) lasting longer than 30 seconds post the 90 day blanking period

Other study objectives

Chronic Effectiveness

Chronic Safety

Effect of Operator Experience on primary effectiveness endpoint

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