Low voltage catheter ablation for treating 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.

This study is testing if a new heart procedure that combines low voltage catheter ablation with pulmonary vein isolation can help people with persistent atrial fibrillation feel better compared to just the standard treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years to 85 Years
• Sex: All
• Sponsor: MetroHealth Medical Center (Academic / other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT03355456 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-85 with non-paroxysmal atrial fibrillation who have failed or are intolerant to at least one antiarrhythmic drug.

Not a fit: Patients with a history of prior left-sided catheter or surgical ablation for atrial fibrillation or those with uncontrolled heart failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved outcomes for patients with persistent atrial fibrillation who have not responded to standard treatments.

How similar studies have performed: Other studies have shown promise with similar ablation techniques, but this specific low voltage-directed approach is relatively novel.

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.

Where this trial is running

Cleveland, Ohio

• MetroHealth Medical Center — Cleveland, Ohio, United States (Recruiting)

Study contacts

• Principal investigator: Ohad Ziv, MD — MetroHealth System, Ohio
• Study coordinator: Peter Leo BS, RN

Conditions Atrial Fibrillation - Symptomatic; Persistent atrial fibrillation; Medication refractory atrial fibrillation; Pulmonary vein isolation procedure; Low voltage directed ablation