NCT03355456 Low Voltage-Directed Catheter Ablation for Atrial Fibrillation
| NCT ID | NCT03355456 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Ohad Ziv |
| Condition | Atrial Fibrillation - Symptomatic |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2019-07-14 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2019-07-14 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: Subjects must meet all of the following criteria: 1. Non-Paroxysmal Atrial Fibrillation. 2. Failed or intolerable to at least 1 one antiarrhythmic drug (AAD). 3. 18-85 year of age at time of consent. 4. Scheduled to undergo a clinically indicated AF ablation procedure. 5. Able and willing to comply with all protocol visit requirements. 6. Signed Patient Informed Consent (ICF). 7. 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: 1. 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. 2. Uncontrolled heart Failure or NYHA Class IIIb or IV heart failure. 3. Ejection Fraction \< 0.20. 4. Active ventricular tachycardia requiring treatment with catheter ablation or anti-arrhythmic drug within the last 6 months. 5. Left atrial size \> 60 mm diameter on echocardiogram. 6. "Long standing" persistent AF defined as \> or = 1 year of continuous atrial fibrillation at the time of enrollment. 7. Severe pulmonary hypertension (PAP \> 70 mmHg) 8. Unstable valvular disease. 9. AF secondary to electrolyte imbalance, thyroid disease or reversible non- cardiac cause. 10. Poor candidate for general anesthesia. 11. Anticipated survival \< 1 year. 12. MI or CABG within 3 months. 13. Left atrial thrombus in pre-procedure imaging within 4 weeks of the ablation procedure. 14. Any documented thromboembolic event within 6 months of the ablation procedure. 15. Contraindication to anticoagulation. 16. 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. 17. Significant congenital anomaly or medical condition that may affect the integrity of study data. 18. Women who are pregnant - pregnancy test required if pre-menopausal or non-sterile. 19. Active enrollment in another investigational study involving a drug or device. 20. Inability to undergo complete voltage mapping in normal sinus rhythm - see intraprocedural protocol. 21. Presence of any medical or psychological condition or medical non-compliance history that may adversely impact study outcomes.
Contact & Investigator
Ohad Ziv, MD
PRINCIPAL INVESTIGATOR
MetroHealth System, Ohio
Frequently Asked Questions
Who can join the NCT03355456 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Atrial Fibrillation - Symptomatic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03355456 currently recruiting?
Yes, NCT03355456 is actively recruiting participants. Contact the research team at pleo@metrohealth.org for enrollment information.
Where is the NCT03355456 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT03355456 clinical trial?
NCT03355456 is sponsored by Ohad Ziv. The principal investigator is Ohad Ziv, MD at MetroHealth System, Ohio. The trial plans to enroll 250 participants.
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