Clinical Investigation of the VytronUS Ablation System for Treatment <br>of Symptomatic Drug-refractory Paroxysmal Atrial Fibrillatio

Completed

• Conditions: Cardiac arrhythmia; recurrent paroxysmal atrial fibrillation; 10007521

• Registration Number: NL-OMON46588
• Lead Sponsor: VytronUS, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

1. Age between 18 and 75 years
2. History of symptomatic recurrent paroxysmal atrial fibrillation (PAF) in the prior year, defined by:
a. Two or more symptomatic AF episodes lasting greater than 30 seconds duration that self-terminate and lasting no more than 7 continuous days. An episode of AF * 48 hours duration terminated with electrical or pharmacologic cardioversion counts as a paroxysmal atrial fibrillation episode.
b. At least one episode of paroxysmal atrial fibrillation (PAF) documented on 12-lead ECG, event monitor, or telemetry monitor in the prior year
3. Paroxysmal atrial fibrillation refractory to at least one Beta Blocker, Calcium Channel Blocker, or Class I or Class III anti-arrhythmic drug (AAD).
4. Subject is indicated for a pulmonary vein ablation according to society guidelines or investigational site practice.
5. Subject is able and willing to give informed consent.
6. Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full duration of the study

Exclusion Criteria

1. Prior LA ablation or surgery
2. Persistent, longstanding persistent, or permanent AF
3. AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause
4. NYHA Class III or IV congestive heart failure
5. Rheumatic heart disease
6. Atrial myxoma
7. LVEF <40% measured by acceptable cardiac testing (e.g. TTE, TEE)
8. Anteroposterior LA diameter >5.5cm or <3.5cm by TTE, CT or MRI
9. Presence of intracardiac thrombus (including a known history of thrombus) within 30 days prior to the index ablation procedure
10. Presence of pulmonary vein stent(s)
11. Presence of pre-existing pulmonary narrowing or pulmonary vein stenosis greater than 70%
12. Presence of pre-existing pericardial effusion
13. Previous mitral valve repair or prosthesis
14. Bleeding diathesis or contraindication to anticoagulation therapy
15. Known blood clotting abnormalities (e.g., genetic)
16. MI, PCI, or cardiac surgery within 90 days prior to the index ablation procedure
17. Previous CVA, TIA, or PE within 3 months prior to the index procedure
18. Structural heart defect that, in the investigator*s opinion, prevents catheter access or increases risk of ablation procedure
19. Pacemaker, ICD, or CRT with pacing leads implanted within 3 months prior to the index ablation procedure
20. Subjects in whom PVI is contraindicated based on an intra-procedural finding such as AVRT/AVNRT will be excluded from the primary endpoint analyses and followed for safety only
21. Active systemic infection
22. Subject contraindicated for both contrast MRI and CT
23. Life expectancy less than 360 days in physician*s opinion
24. Participation in a drug or device study that could conflict with this study
25. Women known to be pregnant or breastfeeding or of childbearing potential unless on satisfactory contraceptive routine
26. Exclusion as per local laws

Study & Design

• Study Type: Interventional
• Study Design: Not specified