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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2023-09-26

Brief Summary

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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.

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Detailed Description

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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

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Heart Block Valve Heart Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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Temporary pacing

Transvenous temporary cardiac pacing - right internal jugular insertion

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subject is undergoing a surgical or an interventional procedure requiring temporary cardiac pacing to support for at least 24 hours per investigator's medical judgement.
2. Subject is at least 18 years of age.
3. Subject or legal representative provides written informed consent to the study.

Exclusion Criteria

1. Subject has a co-exist temporary pacing or an implanted active permanent pacemaker or a cardiac defibrillator.
2. Subject on cardiogenic shock.
3. Subject is currently in atrial fibrillation.
4. Subject is pregnant or breastfeeding.
5. Subject had a stroke within 6 months prior to enrollment.
6. Subject has renal insufficiency with creatinine \>2 mg/dl.
7. Subject with known bleeding diathesis.
8. Subject with a history of deep vein thrombosis or pulmonary embolization within 6 months.
9. Subject with known tricuspid valve disease that may impede catheter advance to and withdrawn from right ventricle.
10. Subject with known intracardiac thrombus or vegetation on echocardiography
11. Subject with significant neck abnormalities such that placement of a right and/or left internal jugular vein line would be difficult.
12. Subject has an active systemic infection or local infection at or around the insertion site.
13. Subject is involved in another clinical study that could influence the safety or outcome measures of this study.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No