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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06261788
Study type	Interventional
Source	Swift Sync, Inc.
Contact
Status	Completed
Phase	N/A
Start date	June 1, 2023
Completion date	September 26, 2023

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms