Clinical Investigation of the VytronUS Ablation System for Treatment of Paroxysmal Atrial Fibrillation

NCT ID: NCT03639597

Last Updated: 2019-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-18
• Study Completion Date: 2018-12-31

Brief Summary

The study is a single center, open-label, single arm, prospective pre-market study designed to assess the safety and efficacy of the VytronUS Ablation System (VAS) for the treatment of atrial fibrillation in patients with drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation.

Detailed Description

Subjects with documented symptomatic, recurrent, PAF refractory to at least one beta blocker, calcium channel blocker or Class I or Class III anti-arrhythmic drug, who meet all inclusion/exclusion criteria and are deemed appropriate candidates for catheter ablation will undergo PV ablation with the VAS. Pre-procedural CT scan or MRI will be obtained to assess LA and PV anatomy and size. PV ablation will be performed utilizing the VAS (see procedure description below). Acute post-ablation confirmation of PV electrical isolation will be evaluated via standard mapping techniques.

Conditions

Paroxysmal Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study device

VytronUS Ablation System

Group Type: EXPERIMENTAL

VytronUS Ablation System

Intervention Type: DEVICE

Interventions

VytronUS Ablation System

Intervention Type: DEVICE

Eligibility Criteria

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.Episodes of AF i.≥2 recurrent AF episodes of more than 30 seconds' duration that self-terminate and lasting no more than 7 continuous days or ii.Episodes of AF ≤ 48 hours duration terminated with electrical or pharmacologic cardioversion count 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. Non-paroxysmal AF (e.g. persistent, long-standing persistent, or permanent AF)

2. AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause.

3. Prior LA ablation or surgery

4. Women known to be pregnant or breastfeeding or of childbearing potential unless on satisfactory contraceptive routine

5. NYHA Class III or IV congestive heart disease

6. LVEF <40% measured by acceptable cardiac testing (eg. TTE, TEE)

7. Anteroposterior LA diameter >5.5cm or <3.0cm by TTE

8. Presence of intracardiac thrombus (including a known history of thrombus) within 30 days prior to the index ablation procedure

9. Presence of pulmonary vein stent(s)

10. Presence of pre-existing pulmonary narrowing or pulmonary vein stenosis

11. Presence of a cardiac valve prosthesis

12. Bleeding diathesis or contraindication to anticoagulation therapy

13. Blood clotting abnormalities (genetic)

14. MI, PCI, invasive cardiac procedure or surgery within 90 days prior to the index ablation procedure

15. Previous CVA, TIA, or PE within 3 months prior to the index procedure

16. Structural heart defect that, in the investigator's opinion, prevents catheter access or increases risk of ablation procedure

17. Pacemaker, ICD, or CRT implantation within 6 months prior to the index ablation procedure

18. Active systemic infection

19. Subject contraindicated for both MRI and CT

20. Life expectancy less than 360 days in physician's opinion

21. Participation in a drug or device study

22. Exclusion as per local laws -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VytronUS, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Na Homolce

Prague, , Czechia

Countries

Czechia

References

Turagam MK, Petru J, Neuzil P, Kakita K, Kralovec S, Harari D, Phillips P, Piazza D, Whang W, Dukkipati SR, Reddy VY. Automated Noncontact Ultrasound Imaging and Ablation System for the Treatment of Atrial Fibrillation: Outcomes of the First-in-Human VALUE Trial. Circ Arrhythm Electrophysiol. 2020 Mar;13(3):e007917. doi: 10.1161/CIRCEP.119.007917. Epub 2020 Feb 12.

Reference Type: DERIVED

PMID: 32078362 (View on PubMed)

Other Identifiers

980-06114-00

Identifier Type: -

Identifier Source: org_study_id