Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001070921
Ethics application status
Approved
Date submitted
26/08/2020
Date registered
19/10/2020
Date last updated
19/10/2020
Date data sharing statement initially provided
19/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effect of ultrasound guided pacemaker or defibrillator lead implantation on tricuspid regurgitation.
Scientific title
Evaluating the Effect of Transesophageal Echocardiography (TOE)- Guided Device Lead Positioning on the development of new or worsening tricuspid regurgitation – the REDUCE-TR Study.
Secondary ID [1] 302150 0
Nil known
Universal Trial Number (UTN)
Trial acronym
REDUCE-TR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tricuspid Regurgitation 318793 0
Condition category
Condition code
Cardiovascular 316810 316810 0 0
Other cardiovascular diseases
Surgery 317125 317125 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention - Pacemaker or defibrillator lead manipulation (by treating proceduralist) under transesophageal echo guidance to ensure the lead is in a commissural position so as to minimise tricuspid regurgitation.
- Approximate duration of procedure: Approximately 10 minutes will be added to the routine procedural time for device implantation, to allow for performance of transesophageal echo in all patients. In addition, a maximum of 8 minutes will be allowed for lead manipulation via echo-guidance in the treatment group.
- Device-lead manipulation will be performed by the treating electrophysiologist. Transesophageal echo will be performed by a cardiac anaethsetist or cardiologist who is part of the research team (who is not the patients treating physician).
- Monitoring for adherence to intervention not required (TOE-guided device-lead manipulation performed during pacemaker/defibrillator implantation)
Intervention code [1] 318452 0
Treatment: Devices
Comparator / control treatment
Comparator - Pacemaker or defibrillator lead manipulation (by treating proceduralist) under fluoroscopy guidance only (as is standard practice). Transesophageal echo will be performed but findings not relayed to proceduralist.
Approximate duration of procedure: Approximately 10 minutes will be added to the routine procedural time for device implantation, to allow for performance of transesophageal echo in all patients.
Device-lead manipulation will be performed by the treating electrophysiologist. Transesophageal echo will be performed by a cardiac anaethsetist or cardiologist who is part of the research team (who is not the patients treating physician).
Control group
Active

Outcomes
Primary outcome [1] 324923 0
Proportion of participants with an increase in degree of tricuspid regurgitation by at least one grade from baseline transthoracic echo (TTE) to TTE at 6 months.
Timepoint [1] 324923 0
6 months following device-implantation.
Secondary outcome [1] 386211 0
Proportion of participants with an increase in degree of tricuspid regurgitation by two or more grades from baseline transthoracic echo (TTE) to TTE at 6 months.
Timepoint [1] 386211 0
6 months following device implantation
Secondary outcome [2] 386212 0
Proportion of participants with an increase in right atrial, right ventricular or tricuspid annular dimensions (composite end-point) from baseline transthoracic echo (TTE) to TTE at 6 months.
Timepoint [2] 386212 0
6 months following device implantation

Eligibility
Key inclusion criteria
1. Clinical indication for device implantation (permanent pacemaker or debfibrillator)
2. Greater than or equal to 18 years of age
3. Able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous endocardial lead
2. Moderate or greater tricuspid regurgitation on baseline transthoracic echocardiography
3. Moderate or severe right ventricular dilatation or systolic dysfunction
4. Estimated right ventricular systolic pressure >70mmHg
5. Suboptimal 3D-TOE images at time of device-implantation
6. Unable to attend 6-month follow up at a designated echo centre.
7. Complete heart block
8. Rapid atrial fibrillation
9. More than one lead across tricuspid valve planned (E.g. His bundle backup lead)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer once initial transesophageal echo pictures obtained
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation (computer generated sequence)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Number of participants = 125 based on power calculation with incidence of device-related TR estimated at 30% and an anticipated outcome for the study group of 10%.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2020
Actual
Date of last participant enrolment
Anticipated
1/11/2021
Actual
Date of last data collection
Anticipated
1/06/2022
Actual
Sample size
Target
125
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 306577 0
Hospital
Name [1] 306577 0
Royal Prince Alfred Hospital
Country [1] 306577 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital
Address
50 Missenden Road, Camperdown, 2050, NSW
Country
Australia
Secondary sponsor category [1] 307102 0
None
Name [1] 307102 0
Address [1] 307102 0
Country [1] 307102 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306761 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 306761 0
Sydney Local Health District
Level 11, KGV Building Missenden Road
CAMPERDOWN NSW 2050
Ethics committee country [1] 306761 0
Australia
Date submitted for ethics approval [1] 306761 0
11/03/2020
Approval date [1] 306761 0
05/05/2020
Ethics approval number [1] 306761 0
X20-0093

Summary
Brief summary
We will conduct a two-centre randomised control study designed to assess the impact of transesophageal (TOE)- guided lead placement on the development of new or worsening tricuspid regurgitation (TR).

All eligible patients will have a TOE at the time of randomisation, as an exclusion criteria is inadequate TOE images. In the treatment arm, the implanter will be guided by the images obtained on the TOE in order to place the lead in a favourable commissural position so as to minimise tricuspid regurgitation. In the control arm, the implanter will be blinded to the findings on TOE and use fluoroscopy to guide lead placement as is standard practice.

The projected duration of the study is 2 years and it is expected that we will enrol 125 patients during this period who require the implantation of a pacemaker (PPM) or automated implantable cardioverter-defibrillator (AICD) as deemed clinically appropriate by their treating cardiologist. The follow-up to assess the primary and secondary endpoints after lead implantation will be at 6-months during a routine clinical follow-up with the treating specialist
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104930 0
Prof David Celermajer
Address 104930 0
Department of Cardiology, Royal Prince Alfred Hospital
50 Missenden Road, Camperdown, 2050, NSW
Country 104930 0
Australia
Phone 104930 0
+61 2 95157110
Fax 104930 0
Email 104930 0
[email protected]
Contact person for public queries
Name 104931 0
Sophie Offen
Address 104931 0
Department of Cardiology, Royal Prince Alfred Hospital
50 Missenden Road, Camperdown, 2050, NSW
Country 104931 0
Australia
Phone 104931 0
+612 95156111
Fax 104931 0
Email 104931 0
[email protected]
Contact person for scientific queries
Name 104932 0
Sophie Offen
Address 104932 0
Department of Cardiology, Royal Prince Alfred Hospital
50 Missenden Road, Camperdown, 2050, NSW
Country 104932 0
Australia
Phone 104932 0
+61 2 95156111
Fax 104932 0
Email 104932 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


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.