RecruitingNot ApplicableNCT03355456
Low Voltage-Directed Catheter Ablation for Atrial Fibrillation
Prospective, Multi-center, Randomized, Evaluation Comparing the Protocol Specified Ablation Approach to the Current Standardized Ablation Approach in the Treatment of Non-paroxysmal Atrial Fibrillation.
Sponsor
Ohad Ziv
Enrollment
250 participants
Start Date
Jul 14, 2019
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 85 Years
Inclusion Criteria8
- Subjects must meet all of the following criteria:
- Non-Paroxysmal Atrial Fibrillation.
- Failed or intolerable to at least 1 one antiarrhythmic drug (AAD).
- 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 Criteria23
- 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.
Interventions
PROCEDURERadiofrequency ablation
Ablation procedure to eliminate atrial fibrillation
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03355456