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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up any event up to 1 year post-ablation.
Awards & highlights
Study 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.Check my eligibility
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).See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ any event up to 1 year post-ablation.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~any event up to 1 year post-ablation.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Freedom from first arrhythmia recurrence defined as sustained symptomatic or asymptomatic atrial fibrillation, atrial flutter or atrial tachycardia.
Secondary outcome measures
Freedom from any symptomatic AF/AT
Freedom from sustained AF/AT
Reduced arrhythmia burden (frequency that arrhythmia occurs).
+1 moreOther outcome measures
Incidence of procedure related adverse events.
Tertiary endpoints
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
122 Previous Clinical Trials
36,337 Total Patients Enrolled
81 Trials studying Atrial Fibrillation
28,254 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am scheduled for a procedure to treat atrial fibrillation.I have had treatment for a serious heart rhythm problem in the last 6 months.A blood clot in the left atrium was seen in imaging within 4 weeks before the ablation procedure.I am not pregnant or have confirmed it with a test if I am capable of becoming pregnant.You are unable to have a certain type of heart test done while your heart is beating normally.I am not a good candidate for general anesthesia.I have had a procedure to correct irregular heartbeats on the left side of my heart.I do not have severe or uncontrolled heart failure.My atrial fibrillation is due to an imbalance in body salts, thyroid issues, or another reversible cause not related to heart disease.I have tried at least one heart rhythm medication that didn't work or caused side effects.I am between 18 and 85 years old.I have had atrial fibrillation for at least 1 year.I have a type of irregular heartbeat that doesn't come and go.I have a heart valve problem that is not stable.It's expected that you will live less than one year.My heart's left atrium showed low voltage during a mapping procedure.I have had a heart attack or bypass surgery in the last 3 months.Your left atrial size is larger than 60 millimeters on an echocardiogram.I have had a blood clot within the last 6 months.Your heart's ejection fraction is less than 20%.I cannot use a heart monitoring device or wear a Holter monitor for 4 weeks.I cannot take blood thinners due to health reasons.I have severe high blood pressure in the lungs.
Research Study Groups:
This trial has the following groups:- Group 1: PVI+Total LT Atrial low voltage ablation
- Group 2: Pulmonary vein isolation (PVI) alone
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this experiment accommodate participants above the age of 80?
"This clinical trial is seeking those who are of legal age and not older than 85 years to participate."
Answered by AI
Are new participants being admitted to this clinical experiment?
"According to clinicaltrials.gov, this research study is presently accepting new participants; the trial was first posted on February 14th 2019 and has most recently been updated March 28th 2022."
Answered by AI
What is the size of the participant pool in this experiment?
"Affirmative. The clinicaltrials.gov website points out that this research trial is currently recruiting patients. This experiment, which was initially advertised on February 14th 2019, desires 250 individuals from a single site to take part in the study."
Answered by AI
What criteria must potential participants meet to join this trial?
"This medical trial seeks 250 candidates, ranging from 18 to 85 years old, who currently suffer from atrial fibrillation. They must also meet 6 other conditions: Non-Paroxysmal Atrial Fibrillation., Failed or intolerable response to an antiarrhythmic drug (AAD)., Ability and willingness to adhere with protocol visit requests., Signed Patient Informed Consent Form (ICF)., Detection of low voltage in the left atrium on 3-D map during index catheter ablation procedure."
Answered by AI
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