NCT06261788

Efficacy and Safety of the Sync-AV II Temporary Cardiac Pacing Catheter

Efficacy and Safety of the Sync-AV II Temporary Cardiac Pacing Catheter (EASY II Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Swift Sync, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-center, non-randomized open label study. The objective of this study is to evaluate the efficacy and safety of the Sync-AV II Temporary Cardiac Pacing Catheter in subjects whose elective surgical or interventional procedure require temporary pacing support.

Detailed description

The study will enroll up to 31 subjects at one investigational site with at least 3 implanters. The subjects enrolled will be followed 7 days after the Sync-AV II Temporary Cardiac Pacing Catheter is removed. A safety call or clinic visit at 7 days post discharge will be performed. Only subjects who meet the inclusion/exclusion criteria and provide informed consent will be eligible to receive the treatment and participate in the study. potential subjects who have a surgical or interventional procedure that will require temporary cardiac pacing support for at least 24 hours per investigator's medical judgement. The elective surgical or interventional procedure is to be performed per institutional standard of care. Other concomitant therapy (medication and non-medication therapies) may be used during the study for the treatment or prevention of disease or to maintain good health. Study Procedure standard of care technique to access the right jugular vein. Thru an introducer the Sync-AV II Temporary Cardiac Pacing Catheter is inserted Confirm and document the leads location as a baseline reference. Acute Pacing Evaluation Acute pacing threshold evaluation will be performed immediate after leads deployed and at the end of the concomitant procedure. Pacing Support During Concomitant Procedure Pacing setting to support for subject's medical need during concomitant procedure is per investigator's discretion. Pacing Support During Hospital Stay Pacing setting to support for subject's medical need during hospital stay is per investigator's discretion. Pacing Evaluation prior to Lead Removal Pacing lead evaluation will be performed immediately prior to the pacing catheter removal. The evaluation protocol will be the same as the lead evaluation at 24 hours post implant. End of Study Subjects will exit the study after 7 days follow-up post procedure.

Conditions

• Heart Block
• Valve Heart Disease

Interventions

Type	Name	Description
DEVICE	Temporary pacing	Transvenous temporary cardiac pacing - right internal jugular insertion

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-09-13
• Completion: 2023-09-26
• First posted: 2024-02-15
• Last updated: 2024-02-15

Locations

1 site across 1 country: Paraguay