Safety and Feasibility Study of the Tempo 'Trademark' Temporary Pacing Lead in New Zealand

Not Applicable

Completed

• Conditions: Subjects who are undergoing a transcatheter cardiac procedure requiring temporary intracardiac pacing.; Cardiovascular - Other cardiovascular diseases; Surgery - Other surgery

• Registration Number: ACTRN12616000306415
• Lead Sponsor: BioTrace Medical Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified