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

Valve Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06261788
• Other study ID #: EASY II Trial
• Status: Completed
• Phase: N/A
• Start date: June 1, 2023
• Est. completion date: September 26, 2023

Study information

• Verified date: February 2024
• Source: Swift Sync, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 26, 2023
• Est. primary completion date: September 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Block
• Heart Diseases
• Heart Valve Diseases
• Valve Heart Disease

Intervention

Device:
• Temporary pacing
Transvenous temporary cardiac pacing - right internal jugular insertion

Locations

Country	Name	City	State
Paraguay	Centro de Intervenciones Endovasculares y Cirugia Cardiovascular	Asunción

Sponsors (2)

Lead Sponsor	Collaborator
Swift Sync, Inc.	Regulatory and Quality Solutions

Country where clinical trial is conducted

Paraguay, 

References & Publications (3)

Lamas GA, Orav EJ, Stambler BS, Ellenbogen KA, Sgarbossa EB, Huang SK, Marinchak RA, Estes NA 3rd, Mitchell GF, Lieberman EH, Mangione CM, Goldman L. Quality of life and clinical outcomes in elderly patients treated with ventricular pacing as compared with dual-chamber pacing. Pacemaker Selection in the Elderly Investigators. N Engl J Med. 1998 Apr 16;338(16):1097-104. doi: 10.1056/NEJM199804163381602. — View Citation

Perez SA, Ebner B, Kall CMY, Mitrani R, de Marchena EJ. A novel temporary atrioventricular sequential pacing catheter-Characteristics and first-in-human application. J Card Surg. 2022 Oct;37(10):2991-2996. doi: 10.1111/jocs.16796. Epub 2022 Jul 28. — View Citation

Tancredi RG, McCallister BD, Mankin HT. Temporary transvenous catheter-electrode pacing of the heart. Circulation. 1967 Oct;36(4):598-608. doi: 10.1161/01.cir.36.4.598. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	With a commercially available pacing box and/or analyzer, measure the ventricular pacing threshold at 24 hours post implant of the investigational device (index procedure)	Number of participants with a mean ventricular pacing threshold of less than 2.1 volts, measured at 24 hours post index procedure.	24 hours post implant
Primary	Procedure related complications	Incidence of serious procedural related complications; The procedure-related serious complication is defined as: Device-related endocarditis; Clinically significant cardiac perforation; New pericardial effusions requiring intervention; Sustained ventricular or atrial arrhythmia; Cardiac tamponade; Bleeding requiring transfusion	through study completion, an average of 7 days