Evaluating the effect of ultrasound guided pacemaker or defibrillator lead implantation on tricuspid regurgitation.

Evaluating the Effect of Transesophageal Echocardiography (TOE)- Guided Device Lead Positioning on the development of new or worsening tricuspid regurgitation – the REDUCE-TR Study.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12620001070921

Acronym

REDUCE-TR

Enrollment

125

Registered

2020-10-19

Start date

2020-11-01

Completion date

2021-11-01

Last updated

2020-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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

Interventions

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)

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

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)

Outcome results