An interventional study of Temporary pacing in Heart Block and Valve Heart Disease, sponsored by Swift Sync, Inc.. Completed at 1 site in Paraguay. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-02-15.
Sponsored by Swift Sync, Inc. · Not applicable, Interventional, and Supportive care
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.
39 studies on the registry are indexed under Heart Block; 12 are open to participants now.
This study's enrollment of 30 is below the median of 104 across 24 interventional studies indexed under Heart Block.
Browse Heart Block studies →This is the only study on the registry with Swift Sync, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Transvenous temporary cardiac pacing - right internal jugular insertion
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.
Time frame: 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
Time frame: through study completion, an average of 7 days
Plan to share: Undecided — will be determined by board of directors at a later time
Ran from Jun 2023 to primary completion in Sep 2023, 3 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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