NCT03355456 · Ohad Ziv
Low Voltage-Directed Catheter Ablation for Atrial Fibrillation
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subjects must meet all of the following criteria:
- Non-Paroxysmal Atrial Fibrillation.
- Failed or intolerable to at least 1 one antiarrhythmic drug (AAD).
- 18-85 year of age at time of consent.
- Scheduled to undergo a clinically indicated AF ablation procedure.
- Able and willing to comply with all protocol visit requirements.
- Signed Patient Informed Consent (ICF).
- Presence of low voltage in the left atrium on 3-D map during index catheter ablation procedure
Exclusion criteria
- Subjects will be excluded if any of the follow criteria are present:
- History of prior left-sided catheter or surgical ablation for AF or atypical atrial flutter, including MAZE or mini MAZE.
- Prior ablation for typical atrial flutter or left-sided ablation for WPW, AV node reentry tachycardia or focal ectopic atrial tachycardia may be included.
- Uncontrolled heart Failure or NYHA Class IIIb or IV heart failure.
- Ejection Fraction \< 0.20.
- Active ventricular tachycardia requiring treatment with catheter ablation or anti-arrhythmic drug within the last 6 months.
- Left atrial size \> 60 mm diameter on echocardiogram.
- "Long standing" persistent AF defined as \> or = 1 year of continuous atrial fibrillation at the time of enrollment.
- Severe pulmonary hypertension (PAP \> 70 mmHg)
- Unstable valvular disease.
- AF secondary to electrolyte imbalance, thyroid disease or reversible non- cardiac cause.
- Poor candidate for general anesthesia.
- Anticipated survival \< 1 year.
- MI or CABG within 3 months.
- Left atrial thrombus in pre-procedure imaging within 4 weeks of the ablation procedure.
- Any documented thromboembolic event within 6 months of the ablation procedure.
- Contraindication to anticoagulation.
- Inability to have implantable monitoring device for atrial fibrillation burden with no pre-existing cardiac device that can monitor atrial arrhythmias OR inability to wear external Holter Monitor continuously for 4 weeks.
- Significant congenital anomaly or medical condition that may affect the integrity of study data.
- Women who are pregnant - pregnancy test required if pre-menopausal or non-sterile.
- Active enrollment in another investigational study involving a drug or device.
- Inability to undergo complete voltage mapping in normal sinus rhythm - see intraprocedural protocol.
- Presence of any medical or psychological condition or medical non-compliance history that may adversely impact study outcomes.
Where
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 10, 2024 · Source of record for eligibility and locations