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Ablation

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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Chronic Effectiveness
Chronic Safety
Effect of Operator Experience on primary effectiveness endpoint
+3 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment2 Interventions
Pulmonary vein isolation ablation with HeartLight Endoscopic Ablation System
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HeartLight
2016
N/A
~190
Ablation
2010
Completed Phase 4
~1390

Find a Location

Who is running the clinical trial?

CardioFocusLead Sponsor
9 Previous Clinical Trials
826 Total Patients Enrolled
9 Trials studying Atrial Fibrillation
826 Patients Enrolled for Atrial Fibrillation

Media Library

Ablation (Ablation) Clinical Trial Eligibility Overview. Trial Name: NCT03168659 — N/A
Atrial Fibrillation Research Study Groups: Treatment
Atrial Fibrillation Clinical Trial 2023: Ablation Highlights & Side Effects. Trial Name: NCT03168659 — N/A
Ablation (Ablation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03168659 — N/A

Frequently Asked Questions

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

Is this investigation being conducted on a wide scale in U.S. hospitals?

"The University of Arizona Sarver HeartCenter in Tucson, Mount Sinai Hospital in New york City, and the University Of Virginia Health System in Charlottesville are hosting this medical trial. Additionally, 4 more clinical sites have been enlisted for patient enrollment."

Answered by AI

What is the highest possible number of individuals engaged in this research?

"Yes, the research team is actively recruiting participants. Clinicaltrials.gov has their trial listed since June 16th 2017 and it was last modified on August 3rd 2021. A total of 250 patients are needed for this medical experiment, which will be conducted across 4 different facilities."

Answered by AI

Are there any vacancies available on this experiment for participants?

"Clinicaltrials.gov indicates that this study, which was first published on June 16th 2017 is presently recruiting participants. The trial's information has been recently modified as of August 3rd 2021."

Answered by AI
~17 spots leftby Oct 2024