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

NCT06261788 | Completed

• 1 other identifier: EASY II Trial
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Block; Valve Heart Disease

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

Temporary pacing DEVICE

Transvenous temporary cardiac pacing - right internal jugular insertion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Subject is at least 18 years of age.
• Subject or legal representative provides written informed consent to the study.

You may not qualify if:

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• Subject with known tricuspid valve disease that may impede catheter advance to and withdrawn from right ventricle.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

Sponsors & Collaborators

• Swift Sync, Inc.: lead
• Regulatory and Quality Solutions: collaborator

Study Sites (1)

Centro de Intervenciones Endovasculares y Cirugia Cardiovascular

Asunción, Paraguay

Location

Related Publications (3)

• 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.

  PMID: 6041872 BACKGROUND

• 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.

  PMID: 9545357 BACKGROUND

• 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.

  PMID: 35900290 BACKGROUND

MeSH Terms

Conditions

Heart Block; Heart Valve Diseases

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: February 15, 2024
• Study Start: June 1, 2023
• Primary Completion: September 13, 2023
• Study Completion: September 26, 2023
• Last Updated: February 15, 2024

Record last verified: 2024-02

Locations

PA (1)