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Procedure
Ablation Procedures for Atrial Fibrillation (PVS-PVI Trial)
N/A
Waitlist Available
Led By Ramesh Hariharan, D, MRCP,FACC, FHRS
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Capability to provide informed consent
Be older than 18 years old
Must not have
Reversible causes of AF
Persistent or permanent AF
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months follow up
Awards & highlights
No Placebo-Only Group
Summary
"This trial aims to compare the time it takes and the number of RF applications needed for a specific type of ablation procedure called Pulmonary vein myocardial sleeves targeted pulmonary vein ablation (PVS-P
Who is the study for?
This trial is for individuals with symptomatic paroxysmal Atrial Fibrillation (AF), a type of irregular heartbeat. Participants should be suitable candidates for the ablation procedures being tested. Specific inclusion and exclusion criteria details are not provided, but typically these would relate to overall health status and any contraindications for the procedures.
What is being tested?
The study compares two types of heart ablation techniques: PVS-PVI that targets pulmonary vein myocardial sleeves using Omnipolar Technology, and conventional WACA. It aims to evaluate which method is more effective in terms of procedure time, safety, number of RF applications needed, and other clinical outcomes.
What are the potential side effects?
While specific side effects are not listed here, generally speaking, ablation procedures may cause complications like bleeding or bruising at the catheter site, damage to blood vessels or heart tissue, arrhythmias (irregular heartbeats), infection risk at the insertion site or rarely more serious complications such as stroke.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am capable of understanding and agreeing to the trial's terms.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My atrial fibrillation can be treated or reversed.
Select...
I have ongoing or permanent atrial fibrillation.
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I have had a procedure to correct heart rhythm problems.
Select...
I was born with a heart condition.
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I have a serious heart valve problem.
Select...
I cannot take blood thinners by mouth due to past bad reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months follow up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months follow up
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change in quality of life as assessed by the Quality of Life (EQ-5D-5L) assessment
Day and time to first recurrence of any documented atrial arrhythmias
Number of Procedure-related complications
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PVS-PVIExperimental Treatment1 Intervention
Group II: WACAActive Control1 Intervention
Find a Location
Who is running the clinical trial?
The University of Texas Health Science Center, HoustonLead Sponsor
956 Previous Clinical Trials
346,036 Total Patients Enrolled
1 Trials studying Atrial Fibrillation
Ramesh Hariharan, D, MRCP,FACC, FHRSPrincipal InvestigatorThe University of Texas Health Science Center, Houston