Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12616000306415
Ethics application status
Approved
Date submitted
25/08/2015
Date registered
9/03/2016
Date last updated
2/06/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety and Feasibility Study of the Tempo 'Trademark' Temporary Pacing Lead in New Zealand
Scientific title
Safety and Feasibility Study of the Tempo (Trademark) Temporary Pacing Lead in patients undergoing a transcatheter cardiac procedure requiring temporary intracardiac pacing in New Zealand
Secondary ID [1] 287327 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Subjects who are undergoing a transcatheter cardiac procedure requiring temporary intracardiac pacing. 295965 0
Condition category
Condition code
Cardiovascular 296244 296244 0 0
Other cardiovascular diseases
Surgery 297151 297151 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 292646 0
Treatment: Devices
Comparator / control treatment
None.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295902 0
Technical feasibility will be evaluated as the ability of a Tempo 'Trademark' Temporary Pacing Lead to achieve pace capture (confirmed through surgical record review).
Timepoint [1] 295902 0
Immediately post lead removal.
Primary outcome [2] 295903 0
Safety will be evaluated as freedom from pericardial effusion or cardiac tamponade. This will be evaluated using echocardiography and or clinical assessment.
Timepoint [2] 295903 0
24 hours post lead removal. Subjects will also be contacted at 30-days post procedure by telephone for safety purposes only.
Secondary outcome [1] 316898 0
N/A
Timepoint [1] 316898 0
N/A

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
The study is not powered to make statistically valid comparisons with historical data. All comparisons will be descriptive in nature.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/01/2016
Date of last participant enrolment
Anticipated
30/06/2016
Actual
8/06/2016
Date of last data collection
Anticipated
Actual
19/09/2016
Sample size
Target
25
Accrual to date
Final
25
Recruitment outside Australia
Country [1] 7111 0
New Zealand
State/province [1] 7111 0

Funding & Sponsors
Funding source category [1] 291888 0
Commercial sector/Industry
Name [1] 291888 0
BioTrace Medical Inc.
Country [1] 291888 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
BioTrace Medical Inc.
Address
831 Bransten Road, Suite L
San Carlos, CA 94070
USA
Country
United States of America
Secondary sponsor category [1] 290553 0
None
Name [1] 290553 0
Address [1] 290553 0
Country [1] 290553 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293396 0
Health and Disability Ethics Committees
Ethics committee address [1] 293396 0
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington
6011
Ethics committee country [1] 293396 0
New Zealand
Date submitted for ethics approval [1] 293396 0
05/09/2015
Approval date [1] 293396 0
28/10/2015
Ethics approval number [1] 293396 0
15/NTA/132

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 59726 0
Dr Mark Webster
Address 59726 0
Department of Cardiology
Auckland City Hospital
Private Bag 92024
Auckland 1024
Country 59726 0
New Zealand
Phone 59726 0
+64 9 307 4949
Fax 59726 0
Email 59726 0
[email protected]
Contact person for public queries
Name 59727 0
Ms Laura Dietch
Address 59727 0
BioTrace Medical Inc.
831 Bransten Road, Suite L
San Carlos, CA 94070
Country 59727 0
United States of America
Phone 59727 0
+16507794742
Fax 59727 0
+16507794746
Email 59727 0
[email protected]
Contact person for scientific queries
Name 59728 0
Ms Laura Dietch
Address 59728 0
BioTrace Medical Inc.
831 Bransten Road, Suite L
San Carlos, CA 94070
Country 59728 0
United States of America
Phone 59728 0
+16507794742
Fax 59728 0
+16507794746
Email 59728 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.