Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617442
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Esophageal Safety of High and Very High Power Short Duration Pulmonary Vein Isolation a Randomized Comparison of the 50W and 90W Power Settings
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Esophageal Safety of High and Very High Power Short Duration Pulmonary Vein Isolation a Randomized Comparison of the 50W and 90W Power Settings
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HPSD-Esophagus
Brief Summary:
Pulmonary vein isolation PVI is the most effective means of maintaining sinus rhythm in atrial fibrillation AF while a widely used approach to PVI is point-by-point radiofrequency RF catheter ablation High power short duration HPSD and very high power short duration eg 90W and 4 sec are increasingly popular technologies featuring higher power and shorter application durations compared to previous methods vHPSD offers similar efficacy to HPSD while further reducing procedure times Atrioesophageal fistula AEF is a rare but deadly complication of PVI while endoscopically detected esophageal lesions are surrogate markers for the risk of AEF Furthermore thermal complications include vagal lesions leading to gastroparesis While there is considerable data on the thermal safety of HPSD technology most studies of vHPSD focus on efficacy and a direct comparison in terms of esophageal safety is lacking In this randomized single-center study we aim to compare the thermal safety of vHPSD to HPSD Furthermore we aimed to determine the anatomical and biophysical factors that predict thermal injury Patients undergoing their first PVI for AF are randomized to either HPSD or vHPSD power setting The primary endpoint of the study is the composite of esophageal mucosal lesion and gastroparesis as assessed at the post-procedural endoscopy within 15 days after the PVI
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None