Advanced Image Supported Lead Placement in Cardiac Resynchronization Therapy: feasibility in a multicentre setting

Recruiting

Conditions: Chronic heart failure with a reduced ejection fraction and dyssynchrony

Registration Number: NL-OMON23393

Lead Sponsor: niversity Medical Center Utrecht

Brief Summary: For previous work, please see Salden OAE et al. Multimodality imaging for real-time image-guided left ventricular lead placement during cardiac resynchronization therapy implantations. 2019. Int J Cardiovasc Imaging. 2019 Jul;35(7):1327-1337.

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

Capacitated adult patients referred for CRT with a class 1 or 2a indication for CRT according to the 2016 European Society of Cardiology Guidelines for the diagnosis and treatment of acute and chronic heart failure.

Exclusion Criteria

Contraindications for implantation of a CRT device;
- Age <18 years or incapacitated adult;
- Pregnancy or lactation
- Subjects with impaired renal function (severe renal insufficiency, GFR < 30 ml/min/1.73m2);
- Atrial fibrillation or atrial fibrillation during MRI
- Documented allergic reaction to gadolinium or contrast agent;
- Impossibility to undergo an MRI scan
- Participation in another clinical study that prohibits any procedures other than standard.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility as assessed by the following feasibility criteria:<br>- Time to perform the placement of the LV lead<br>- Overall CRT implantation procedure duration<br>- Number of LV lead repositioning procedures.<br><br>Validation of the accuracy of 2D image registration compared to standard 3D image registration (in five patients).<br>- Procedural efficiency scored by the implanting cardiologist

Secondary Outcome Measures

Name	Time	Method
Safety:<br>- Radiation dose during the procedure<br>- (Serious) adverse events<br><br>Efficacy:<br>- Relative reduction in left ventricle end-systolic volume (LVESV), at 6-month follow-up.<br>- Proportion of volumetric responders (= 15% reduction in LVESV), at 6-month follow-up.<br>- Reduction in log-transformed NT-proBNP, at 2-month follow-up.