ACTRN12620001070921
Not yet recruiting
未知
Evaluating the Effect of Transesophageal Echocardiography (TOE)- Guided Device Lead Positioning on the development of new or worsening tricuspid regurgitation – the REDUCE-TR Study.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Royal Prince Alfred Hospital
- Enrollment
- 125
- Status
- Not yet recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Not specified
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