No registrations found.
ID
Source
Brief title
Health condition
Chronic heart failure with a reduced ejection fraction and dyssynchrony
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility as assessed by the following feasibility criteria:
- Time to perform the placement of the LV lead
- Overall CRT implantation procedure duration
- Number of LV lead repositioning procedures.
Validation of the accuracy of 2D image registration compared to standard 3D image registration (in five patients).
- Procedural efficiency scored by the implanting cardiologist
Secondary outcome
Safety:
- Radiation dose during the procedure
- (Serious) adverse events
Efficacy:
- Relative reduction in left ventricle end-systolic volume (LVESV), at 6-month follow-up.
- Proportion of volumetric responders (≥ 15% reduction in LVESV), at 6-month follow-up.
- Reduction in log-transformed NT-proBNP, at 2-month follow-up.
Background summary
Cardiac resynchronization therapy (CRT) is an established pacemaker therapy for patients with symptomatic chronic heart failure, but is hampered by a non-response rate of 30-40%. Optimising left ventricular lead placement is the cornerstone of improving treatment. The optimal location for the lead is remote from scar but within segments demonstrating late electromechanical activation. The present study aims to investigate the feasibility of the use of real-time guided lead placement using cardiac MRI and fluroscopy in a multicentre setting.
Study objective
1. Targeted LV-lead delivery is safe and feasible in a multicenter setting.
2. Image-registration using 2D fluroscopy is non-inferior compared to standard 3D image registration (validation in first five patients).
3. Targeted LV-lead delivery will increase the proportion of responders, as compared to historic percentage of responders (60-70%).
Study design
Timepoint 1: Pre-implantation CMR and echocardiography
Timepoint 2: Guided CRT implantation
Intervention
Real-time cardiac Magnetic Resonance-guided lead implantation by CARTBox.
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.
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8506 |
| CCMO | NL67885.041.19 |
| OMON | NL-OMON49313 |