None listed
Conditions
Brief summary
This is a prospective, multi-center, single-arm (non-randomized) safety and technical feasibility study. Hypothesis: The Temp 'Trademark' Temporary Pacing Lead is a safe and technically feasible device for temporary intracardiac pacing. Subjects who are undergoing a transcatheter cardiac procedure requiring temporary intracardiac pacing. A total of up to 25 subjects may be enrolled.
Interventions
To evaluate the safety and technical feasibility of the Tempo 'Trademark' Temporary Pacing Lead to temporarily control cardiac rhythm. Temporary intracardiac (meaning "within the heart") pacing is when your heart rate or rhythm is regulated by an external pacing device that is attached to a pacing lead, which has been positioned within the heart. The pacing lead transmits information to the external pacing device about the heart's rate and rhythm. The pacing device can be programmed to deliver e
To evaluate the safety and technical feasibility of the Tempo 'Trademark' Temporary Pacing Lead to temporarily control cardiac rhythm. Temporary intracardiac (meaning "within the heart") pacing is when your heart rate or rhythm is regulated by an external pacing device that is attached to a pacing lead, which has been positioned within the heart. The pacing lead transmits information to the external pacing device about the heart's rate and rhythm. The pacing device can be programmed to deliver electrical impulses to the heart via the pacing lead in order to help regulate the rate or rhythm if required. A cardiologist places this device during a minimally invasive procedure lasting less than fifteen minutes in duration. This type of temporary pacing is used on a short term basis only - usually for up to a few days only. For This device, it will not be used for more than 7 days. Should you need pacing for longer than 7 days, another commercially available pacing lead will be used.
Sponsors
BioTrace Medical Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subject requires temporary intracardiac pacing. Subject is a surgical candidate and able to tolerate general anesthesia. Subject scheduled to undergo TAVR, BAV or an EP procedure.
Exclusion criteria
Subject has a prosthetic tricuspid valve. Subject has a history of known coagulopathy and/or thrombocytopenia (platelets <100). Immediately prior to the procedure, there is presence of greater than mild pericardial effusion. Subject has a history of major bleeding within previous 6 months of the planned procedure, or an absolute contraindication to anticoagulation therapy. For EP Subjects Only: Subject may not be 75 years of age or older at the time of consent (inclusive).
Outcome results
None listed