Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06261788
Status:
COMPLETED
Last Update Posted:
2024-02-15
First Post:
2024-01-31
Brief Title:
Efficacy and Safety of the Sync-AV II Temporary Cardiac Pacing Catheter
Sponsor:
Swift Sync Inc
Organization:
Swift Sync Inc
Study Overview
Official Title:
Efficacy and Safety of the Sync-AV II Temporary Cardiac Pacing Catheter EASY II Trial
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 inclusionexclusion 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 investigators 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 subjects medical need during concomitant procedure is per investigators discretion
Pacing Support During Hospital Stay Pacing setting to support for subjects medical need during hospital stay is per investigators 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
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 inclusionexclusion 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 investigators 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 subjects medical need during concomitant procedure is per investigators discretion
Pacing Support During Hospital Stay Pacing setting to support for subjects medical need during hospital stay is per investigators 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None