None listed
Conditions
Brief summary
A Trans-Esophageal ElectroPhysiological Study (TE-EPS, TEEPS), uses an oesophageal probe to sense and pace the heart together with an electrocardiogram to perform a limited electrophysiology Study. For adults it is potentially a less invasive, more rapid and more cost-effective strategy for some heart rhythm disorders. TEEPS provides a diagnosis of SVT (supraventricular tachycardia) comparable to that an invasive electrophysiology study and can terminate the arrhythmia. Historical TEEPS systems require at least three interconnected systems, limiting applicability and ease-of-access. In this pilot study using a novel integrated system, fifteen patients scheduled to undergo EP Study will first undergo an additional 20-30 minute TEEPS study before proceeding to a routine invasive EP study. Fifteen further patients will be recruited from emergency department presentations with suspected SVT. TEEPS data will be evaluated for operator- and patient-related qualitative criteria to inform a future study of TEEPs to improve arrhythmia management in the emergency department.
Interventions
TEEPS will be performed by qualified cardiologist aided by medical staff trained in passing nasogastric tubes and according to the FIAB™ oesophageal catheter instruction and safety information. All the procedure data will be maintained in the timely manner on patient as well as proceduarl data questionnaire sheet.
Intervention is the physician’s choice to use the OneStim TEEPS procedure (OneStim CE approved) on a patient who has either given full medical consent to undergo a cardiac electrophy
TEEPS will be performed by qualified cardiologist aided by medical staff trained in passing nasogastric tubes and according to the FIAB™ oesophageal catheter instruction and safety information. All the procedure data will be maintained in the timely manner on patient as well as proceduarl data questionnaire sheet. Intervention is the physician’s choice to use the OneStim TEEPS procedure (OneStim CE approved) on a patient who has either given full medical consent to undergo a cardiac electrophysiology procedure or presented to the emergency department with a suspected SVT. o The 5 lead surface ECG (sECG) wires from the OneStim will be connected to the patient. o A 7F esophageal pacing catheter is lubricated with xylocaine gel and slowly advanced into the esophagus via the nose. Once in place the catheter will be taped in place. o Recordings will be made of the heart rhythm from the catheter in the esophagus o Pacing of the heart will be performed via the catheter in the esophagus o The intention of the pacing will be to possibly induce and diagnose any heart arrhythmia o The procedure will be finished when an arrhythmia is identified or when the pacing protocol is complete and no arrhythmia is induced. o At completion of the procedure the catheter will be withdrawn from the nose o The procedure is expected to last approximately 15-30 minutes o The patient will then undergo the intracardiac electrophysiology study o There is no follow up required Prior to the commencement of the intracardiac electrophysiology procedure, the patient will undergo the OneStim TEEPS procedure. This procedure is expected to last no longer than 30 minutes. For patients presenting to the Emergency Department, the OneStim TEEPS procedure will be performed in the Emergency Department. A trans-oesophageal catheter will be introduced into the oesophagus via the nose. Pacing of the atria will be performed to induce tachycardia. Measurements will be recorded throughout the procedure. During the procedure the patient’s vital signs including heart rate, blood pressure, pulse oximetry and respiratory rate will be monitored. Post completion of The OneStim TEEPS procedure the patient will continue with their care as previously arranged (either proceeding with an electrophysiology study or emergency department care). The patient’s vital signs will continue to be monitored during the post procedure period according to usual department protocols. The patient experience with the OneStim TEEPS procedure will be captured using proceduralist and patient questionnaire.
Sponsors
The University of Adelaide
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with palpitations or syncope suspected or documented to be due to SVT and either: • Scheduled for a diagnostic ± ablation intracardiac electrophysiology procedure • Considered for diagnostic ± ablation intracardiac electrophysiology procedure, in patients who have presented to the Emergency Department
Exclusion criteria
• Patients with previous pharynx or oesophageal surgery • Acute upper respiratory tract inflammation. • Large aortic aneurysm. • Severe oesophageal disease. • Any disease or disorder which would lead to the patients intolerance to oesophageal catheter insertion • Women who are pregnant • Children/young people under 18 years old • Patients who are highly dependent on medical care who may be unable to give consent • Patients with cognitive impairment, intellectual disability or mental illness • Patients in in dependent or unequal relationships
Outcome results
None listed