Low voltage catheter ablation for treating atrial fibrillation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the long-term success of a low voltage-directed catheter ablation approach combined with pulmonary vein isolation (PVI) for patients with non-paroxysmal atrial fibrillation. Participants will be randomized to receive either the combined treatment or PVI alone, following a thorough assessment of their heart's electrical activity using 3-D mapping. All patients will also receive optimal medical therapy and anticoagulation as per established guidelines. Continuous monitoring for atrial arrhythmias will be conducted using implantable loop recorders or alternative methods.

Why it matters

Who can join: the full rules

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.

Where it's running

• MetroHealth Medical Center
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Ohad Ziv, MD — MetroHealth System, Ohio
• Study coordinator: Peter Leo BS, RN
• Email: pleo@metrohealth.org
• Phone: 216-778-2714

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.