Clinical trial NCT06261788: Efficacy and Safety of the Sync-AV II Temporary Cardiac Pacing Catheter
Official title: Efficacy and Safety of the Sync-AV II Temporary Cardiac Pacing Catheter (EASY II Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Block
Valve Heart Disease
Lead sponsor: Swift Sync, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Regulatory and Quality Solutions
First posted: 2024-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: 24 hours post implant
measure: Procedure related complications
timeFrame: through study completion, an average of 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Asunción
country: Paraguay
facility: Centro de Intervenciones Endovasculares y Cirugia Cardiovascular
Study officials:
References:
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.
citation: 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.
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.