Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001175965
Ethics application status
Approved
Date submitted
25/09/2020
Date registered
9/11/2020
Date last updated
7/10/2022
Date data sharing statement initially provided
9/11/2020
Date results information initially provided
7/10/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the implications of prophylactic permanent pacemaker implantation for patients undergoing Transcatheter Aortic Valve Implantation (TAVI)
Scientific title
Prophylactic permanent pacemaker implantation in Transcatheter Aortic Valve Implantation (TAVI) patients: Impact on heart rhythm and subsequent pacing burden requirement
Secondary ID [1] 302235 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Rhythm Disorder 318947 0
Cardiac Valve Disease 318948 0
Condition category
Condition code
Cardiovascular 316919 316919 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Assess the change in pacing parameters of permanent pacemaker (PPM) associated with altered cardiac rhythm following TAVI performed at the Royal Adelaide Hospital between 1st January 2014 until 31st December 2019. This is a retrospective analysis of patients in the Structural Cardiology TAVI database. The intervention (TAVI) is the inclusion criteria for this database and the peri-procedural implant of a PPM is the inclusion criteria for this analysis. All data collected will be pooled for analysis to answer the hypotheses as listed. The pacing parameters over follow up of patients who had Pre-TAVI (prophylactic) PPM implantation will be compared against patients who had Post-TAVI PPM implantation.
Intervention code [1] 318526 0
Not applicable
Comparator / control treatment
Given that AV conduction can recover after conduction system damage during TAVI procedure, we will compare the longer term follow-up pacing burden of the patient group receiving prophylactic PPM pre-TAVI against the patient group in the database who received PPM peri-TAVI (up to 30 days post-TAVI). This patient group will act as a control for assessing changes in pacing burden (as a surrogate for late AV conduction recovery) and associated programming changes.
Control group
Active

Outcomes
Primary outcome [1] 325028 0
Impact of implantation of Transcatheter Aortic Valve Implant (TAVI) on pacing burden requirement assessed by the percentage of ventricular pacing during follow up.
Timepoint [1] 325028 0
Assessed from hospital medical records from implant until 31st December 2019, for prophylactic implant (up to 100 days pre-TAVI) and post-TAVI (up to 30 days post-TAVI) performed at Royal Adelaide Hospital between 1st January 2014 to 31st December 2019
Secondary outcome [1] 386587 0
Impact of implantation of Transcatheter Aortic Valve Implant (TAVI) on the rhythm status of patients with a Permanent Pacemaker (PPM) insitu assessed by the rhythm check performed during follow ups.
Timepoint [1] 386587 0
Assessed from hospital medical records from implant until 31st December 2019, for prophylactic implant (up to 100 days pre-TAVI) and post-TAVI (up to 30 days Post-TAVI) performed at Royal Adelaide Hospital between 1st January 2014 to 31st December 2019.
Secondary outcome [2] 386588 0
Any difference in pacing requirements between patients with PPM implanted post-TAVI and patients with PPM implanted pre-TAVI assessed by the programming mode selection and adjustment made for the PPM during follow up.
Timepoint [2] 386588 0
Assessed from hospital medical records from implant until 31st December 2019, for prophylactic implant (up to 100 days pre-TAVI) and post-TAVI (up to 30 days post-TAVI) performed at Royal Adelaide Hospital between 1st January 2014 to 31st December 2019.

Eligibility
Key inclusion criteria
1) Transcatheter Aortic Valve Implantation (TAVI) performed at Royal Adelaide Hospital.
2) Permanent Pacemaker (PPM) implanted within 100 days pre-TAVI or 30 days post-TAVI.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nil.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Continuous data will be presented as the mean ± SD, or median when appropriate, and compared with 2-tailed Student t tests. Nominal data will be presented as frequencies and percentages and compared by Chi-squared test. Statistical analyses will be performed using
SPSS (IBM SPSS Inc, Chicago, IL) and GraphPad Prism (GraphPad Software, Inc, San Diego, CA). A p-value of less than .05 will be used for statistical significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/11/2020
Actual
30/11/2020
Date of last participant enrolment
Anticipated
30/11/2021
Actual
7/10/2022
Date of last data collection
Anticipated
30/11/2021
Actual
7/10/2022
Sample size
Target
30
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 17638 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 31384 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 306657 0
Self funded/Unfunded
Name [1] 306657 0
Nil.
Country [1] 306657 0
Primary sponsor type
Individual
Name
A/Prof Dennis Lau
Address
Centre for Heart Rhythm Disorders, Department of Cardiology, Royal Adelaide Hospital, Port Rd, Adelaide, South Australia, 5000
Country
Australia
Secondary sponsor category [1] 307382 0
None
Name [1] 307382 0
Nil.
Address [1] 307382 0
Nil.
Country [1] 307382 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306838 0
Central Adelaide Local Health Network Human Research Ethics Committee
Ethics committee address [1] 306838 0
Royal Adelaide Hospital, Port Rd, Adelaide SA 5000.
Ethics committee country [1] 306838 0
Australia
Date submitted for ethics approval [1] 306838 0
14/07/2020
Approval date [1] 306838 0
31/08/2020
Ethics approval number [1] 306838 0
CALHN Reference Number: 13524

Summary
Brief summary
Transcatheter aortic valve implantation (TAVI) is a less-invasive, non-surgical approach for the treatment of severe aortic stenosis. With each successive generation of the transcatheter heart valve, combined with increasing experience of the proceduralists/heart teams, the outcomes have been more successful, and the risk of complications have been decreasing. One of the commonest complications of the TAVI procedure is the associated conduction abnormality (atrioventricular and intraventricular conduction blocks) which may require insertion of a Permanent Pacemaker (PPM). This is often performed post TAVI procedure, however certain patients undergo prophylactic insertion of PPM pre-TAVI. We will compare the follow up outcomes for each of these groups to assess differences in their heart rhythm following TAVI and associated requirement for PPM.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105190 0
A/Prof Dennis H. Lau
Address 105190 0
Centre for Heart Rhythm Disorders, Cardiology Department, Royal Adelaide Hospital, Port Rd, Adelaide, South Australia, 5000
Country 105190 0
Australia
Phone 105190 0
+61 8 7074 0000
Fax 105190 0
Email 105190 0
[email protected]
Contact person for public queries
Name 105191 0
A/Prof Dennis H. Lau
Address 105191 0
Centre for Heart Rhythm Disorders, Cardiology Department, Royal Adelaide Hospital, Port Rd, Adelaide, South Australia, 5000
Country 105191 0
Australia
Phone 105191 0
+61 8 8313 9000
Fax 105191 0
Email 105191 0
[email protected]
Contact person for scientific queries
Name 105192 0
A/Prof Dennis H. Lau
Address 105192 0
Centre for Heart Rhythm Disorders, Cardiology Department, Royal Adelaide Hospital, Port Rd, Adelaide, South Australia, 5000
Country 105192 0
Australia
Phone 105192 0
+61 8 8313 9000
Fax 105192 0
Email 105192 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not included in approved Ethics application.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Bradley M. Pitman, Natalie Montarello, Nicholas Mo... [More Details]
Plain language summaryNo We have identified specific characteristics associ... [More Details]

Documents added automatically
No additional documents have been identified.