Actively Recruiting
Low Voltage-Directed Catheter Ablation for Atrial Fibrillation
Led by Ohad Ziv · Updated on 2024-06-10
250
Participants Needed
1
Research Sites
441 weeks
Total Duration
On this page
Sponsors
O
Ohad Ziv
Lead Sponsor
B
Biosense Webster, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
A two-pronged approach to evaluate long term success of non-paroxysmal ablation when using a: 1. specified low voltage-directed with pulmonary vein isolation (LD+PVI) approach compared to , 2. an approach of pulmonary vein isolation (PVI) alone.
CONDITIONS
Official Title
Low Voltage-Directed Catheter Ablation for Atrial Fibrillation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with non-paroxysmal atrial fibrillation
- Failed or intolerant to at least one antiarrhythmic drug
- Aged between 18 and 85 years at consent
- Scheduled for a clinically indicated atrial fibrillation ablation procedure
- Able and willing to follow all study visit requirements
- Provided signed informed consent
- Presence of low voltage in the left atrium detected during 3-D mapping at ablation procedure
You will not qualify if you...
- Previous left-sided catheter or surgical ablation for atrial fibrillation or atypical atrial flutter
- Uncontrolled heart failure or NYHA Class IIIb or IV heart failure
- Ejection fraction below 0.20
- Active ventricular tachycardia needing treatment within the past 6 months
- Left atrial size greater than 60 mm diameter
- Continuous atrial fibrillation for one year or more at enrollment
- Severe pulmonary hypertension (PAP over 70 mmHg)
- Unstable valvular heart disease
- Atrial fibrillation due to reversible causes like electrolyte imbalance or thyroid disease
- Poor candidate for general anesthesia
- Expected survival less than one year
- Recent heart attack or bypass surgery within 3 months
- Left atrial thrombus found within 4 weeks before ablation
- Thromboembolic event within 6 months before ablation
- Contraindication to anticoagulation
- Unable to use implantable or external continuous heart rhythm monitoring devices
- Significant congenital anomalies or medical conditions affecting study data
- Pregnant women
- Currently enrolled in another investigational drug or device study
- Unable to complete voltage mapping in normal sinus rhythm
- Medical or psychological conditions or history of non-compliance that could affect study outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Actively Recruiting
Research Team
P
Peter Leo BS, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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