Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Regulatory and Quality Solutions | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Temporary pacing | Device | Transvenous temporary cardiac pacing - right internal jugular insertion |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| through study completion, an average of 7 days |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Intervenciones Endovasculares y Cirugia Cardiovascular | Asunción | Paraguay |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6041872 | Background | 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. | |
| 9545357 | 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. |
Not provided
Not provided
will be determined by board of directors at a later time
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006327 | Heart Block |
| D006349 | Heart Valve Diseases |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 35900290 | 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. |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |