Study of a Novel Medical Device to Monitor Esophageal Luminal Temperature During Cardiac Ablation of Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— AF-02  

Official title:

Study of a Novel Medical Device to Monitor Esophageal Luminal Temperature During Cardiac Ablation of Atrial Fibrillation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05587959
• Other study ID #: AF-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 2023
• Est. completion date: July 2025

Study information

• Verified date: October 2022
• Source: BioTex, Inc.
• Contact: Britnee L Ochabski
• Phone: 713-741-0111
• Email: britnee.ochabski[@]biotexmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Esophageal temperature monitoring during certain cardiac ablation procedures, such as left cardiac ablation procedures, is an accepted and important part of many clinical procedures today. The primary risk of the temperature monitoring devices relates to performance. Inadequate temperature recording, inadequate capture of peak temperatures or slow temperature response times can lead to inadequate monitoring of the ablation procedure.

The E-SAFE Esophageal Temperature Probe (E-SAFE) is a unique combination of currently available technologies that improves the accuracy of esophageal temperature monitoring. The incremental improvements of the E-SAFE device provide accurate, precise and fast measurement of esophageal temperature during cardiac ablation procedures. Accurate esophageal temperature monitoring must be accomplished safely; therefore, the rationale of this pivotal clinical investigation is to evaluate the safety and clinical performance of the E-SAFE device in monitoring esophageal temperature during AF ablation procedures.

Esophageal temperature monitoring should be used together with all standard clinical practices for esophageal protection during cardiac ablation procedures.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 144
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 80 Years

Eligibility

Inclusion Criteria:

1. The subject has signed and dated the Informed Consent Form.

2. The subject has stated understanding and willingness to comply with all clinical investigation procedures and availability for the duration of the clinical investigation.

3. The subject is 22-80 years of age.

4. The subject's life expectancy is >1 year.

5. Participant is planned for an initial radiofrequency (RF) catheter ablation procedure for symptomatic AF that includes pulmonary vein isolation (PVI) using general anesthesia (GA).

6. The subject is willing and able to undergo general anesthesia.

Exclusion Criteria:

1. Unhealthy BMI

2. The subject has a known allergy to contents of the device: Polypropylene, Polyisoprene Rubber, PEBAX (Poly Ether Block Amide Chain), or PET (Polyethylene Terephthalate).

3. The subject is any of the following: pregnant, planning on becoming pregnant during the investigation, lactating, incarcerated, part of any other vulnerable population, or enrolled in another clinical investigation.

4. The subject is unable to undergo upper endoscopy.

5. Planned AF ablation procedure to be completed with laser energy or with cryo-energy.

6. The subject has a history of esophageal pathology (such as esophageal achalasia, strictures, web, carcinoma, tumor/mass, scleroderma, Mallory-Weiss tear, diverticulum, banding, laceration, perforation, balloon dilatation) that in the opinion of the Investigator would preclude enrollment in the investigation.

7. The subject has known prior esophageal surgery, deviation or esophageal deformity, or evidence or esophageal trauma, prior radiation therapy involving the esophagus, previous esophageal diseases (such as Barrett's esophagitis, varices, cirrhosis), history of esophagectomy, previous swallowing disorders or dysphagia, achalasia, or other known anatomical anatomy of the esophagus.

8. Presence of a pH probe deployed in the esophagus.

9. The subject has a history of blood clotting, bleeding abnormalities or contraindication to anticoagulation (heparin, warfarin, or dabigatran), significant pulmonary disease (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs (including a respiratory system that produces severe chronic symptoms).

10. The subject has had Coronary Artery Bypass Grafting (CABG) in conjunction with valvular surgery, cardiac surgery (e.g. ventriculotomy, atriotomy) or valvular cardiac (surgical or percutaneous) procedure.

11. The subject has had prior cardiac ablation in any part of the left atrium.

12. The subject has been previously diagnosed with persistent atrial fibrillation (> 7 days in duration).

13. The subject has severe dilation of the LA (LAD >50mm antero-posterior diameter in case of Transthoracic echocardiography (TTE).

14. The subject has presence of LA thrombus, LVEF <40%, NYHA Class III or IV heart failure, pulmonary vein stenosis, acute or uncontrolled psychiatric illness, other acute illness, active systemic infection or sepsis, severe mitral regurgitation, or an unstable medical condition(s) that precludes safely completing the investigation.

15. The subject has intracardiac thrombus, myxoma, tumor, interatrial baffle or patch that precludes catheter introduction or manipulation.

16. The subject has presence of an implanted pacemaker or Implantable Cardioverter - Defibrillator (ICD) or other implanted metal cardiac device that may interfere with the IRE energy field.

17. The subject has presence of a condition that precludes vascular access (such as an IVC filter).

18. The subject has any significant congenital anomaly, PV anomaly, other co-morbidity or medical problem that in the opinion of the Investigator precludes enrollment in the investigation.

19. The subject has an anticipated cardiac transplantation, cardiac surgery or other major surgery within the next 12 months.

20. The subject has a documented thromboembolic event (including TIA) or an unstable angina pectoris within the past 6 months.

21. The subject has had a previous PCI/MI within the past 2 months.

22. The subject has esophageal bleeding or has known ingestion of acidic or caustic poisons within 24 hours of the procedure.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• E-SAFE
Esophageal temperature monitoring using the E-SAFE device should be used together with all standard clinical practices for esophageal protection during cardiac ablation procedures.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
BioTex, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To verify the safety of the E-SAFE device for monitoring esophageal luminal temperature.	Mechanical injury evaluation of severe trauma (Severe Adverse Device Effects [ADEs]) via endoscopy procedure.	45 days
Secondary	To evaluate acute procedure success of the E-SAFE device.	Assessment of device functionality (balloon inflation/seal/vacuum) via Fluoroscopy.	36 hours