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Procedure

Radiofrequency Ablation for Atrial Fibrillation

N/A
Recruiting
Led By Ohad Ziv, MD
Research Sponsored by Ohad Ziv
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Failed or intolerable to at least 1 one antiarrhythmic drug (AAD).
18-85 year of age at time of consent.
Must not have
History of prior left-sided catheter or surgical ablation for AF or atypical atrial flutter, including MAZE or mini MAZE.
Uncontrolled heart Failure or NYHA Class IIIb or IV heart failure.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up any event up to 1 year post-ablation.
Awards & highlights
No Placebo-Only Group

Summary

This trial compared the long-term success of two different approaches to ablation for atrial fibrillation. The first approach used low voltage-directed ablation with pulmonary vein isolation (LD+PVI). The second approach used pulmonary vein isolation (PVI) alone. The trial found that the LD+PVI approach was more successful than the PVI approach.

Who is the study for?
This trial is for adults aged 18-85 with non-paroxysmal atrial fibrillation who've had a bad reaction or no success with at least one antiarrhythmic drug and are scheduled for an AF ablation procedure. They must not have severe heart issues, recent strokes, or be pregnant, among other exclusions.
What is being tested?
The study compares two techniques to treat atrial fibrillation: one combines low voltage-directed ablation with pulmonary vein isolation (LD+PVI), while the other uses only pulmonary vein isolation (PVI).
What are the potential side effects?
Potential side effects of radiofrequency ablation include discomfort at the catheter insertion site, bleeding or infection risks, possible damage to blood vessels or heart tissue, and in rare cases more serious complications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have tried at least one heart rhythm medication that didn't work or caused side effects.
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I am between 18 and 85 years old.
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I have a type of irregular heartbeat that doesn't come and go.
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My heart's left atrium showed low voltage during a mapping procedure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a procedure to correct irregular heartbeats on the left side of my heart.
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I do not have severe or uncontrolled heart failure.
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I have had atrial fibrillation for at least 1 year.
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I have a heart valve problem that is not stable.
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I have had a heart attack or bypass surgery in the last 3 months.
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I have had a blood clot within the last 6 months.
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I cannot use a heart monitoring device or wear a Holter monitor for 4 weeks.
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I cannot take blood thinners due to health reasons.
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I have severe high blood pressure in the lungs.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~any event up to 1 year post-ablation.
This trial's timeline: 3 weeks for screening, Varies for treatment, and any event up to 1 year post-ablation. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Freedom from first arrhythmia recurrence defined as sustained symptomatic or asymptomatic atrial fibrillation, atrial flutter or atrial tachycardia.
Secondary study objectives
Freedom from any symptomatic AF/AT
Freedom from sustained AF/AT
Reduced arrhythmia burden (frequency that arrhythmia occurs).
+1 more
Other study objectives
Incidence of procedure related adverse events.
Tertiary endpoints

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: PVI+Total LT Atrial low voltage ablationActive Control1 Intervention
PVI radiofrequency ablation along with ablation of areas of "low voltage" identified.
Group II: Pulmonary vein isolation (PVI) aloneActive Control1 Intervention
Radiofrequency ablation procedure to isolate pulmonary veins without other intervention performed..

Find a Location

Who is running the clinical trial?

Ohad ZivLead Sponsor
Biosense Webster, Inc.Industry Sponsor
126 Previous Clinical Trials
36,813 Total Patients Enrolled
85 Trials studying Atrial Fibrillation
28,730 Patients Enrolled for Atrial Fibrillation
Ohad Ziv, MD5.05 ReviewsPrincipal Investigator - The MetroHealth System
MetroHealth Medical Center
5Patient Review
Dr. Ziv is very comprehensive in his examination and he makes sure to explain complicated concepts in a way that patients can understand.

Media Library

Low Voltage-Directed Catheter Ablation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03355456 — N/A
Atrial Fibrillation Research Study Groups: PVI+Total LT Atrial low voltage ablation, Pulmonary vein isolation (PVI) alone
Atrial Fibrillation Clinical Trial 2023: Low Voltage-Directed Catheter Ablation Highlights & Side Effects. Trial Name: NCT03355456 — N/A
Low Voltage-Directed Catheter Ablation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03355456 — N/A
~55 spots leftby May 2026
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