Advanced Image Supported Lead Placement in Cardiac Resynchronization Therapy

Recruiting

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

Registration Number: NL-OMON29327

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: 130

Inclusion Criteria

Heart failure with LV ejection fraction = 35%;
- New York Heart Association class II, III, or IV (ambulatory);
- Optimal medical treatment that is tolerable;
- Left bundle branch block (LBBB) and QRS = 130 ms, OR non-LBBB and QRS = 150 ms.

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;
- 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
Differences in % of patients with succesfull LV lead location between intervention and control group.

Secondary Outcome Measures

Name	Time	Method
Secondary Outcomes:<br>- Change in LV end-systolic volume, and proportion of volumetric response.<br>- Change in EQ-5D-5L, a quality of life questionnaire.<br>- Change in Kansas City Cardiomyopathy Questionnaire, a quality of life questionnaire.<br>- Change in CRT response score, a hierarchical clinical endpoint combining relative LVESVi-decrease, change in New York Heart Association class, and death at 12 month follow-up.<br>- Health Technology Assessment.<br><br>Other Outcomes:<br>- Difference in total implantation procedure time.<br>- Difference in total fluoroscopy time during procedure.<br>- Difference in total contrast dose used during procedure.<br>- Difference in change in QRS duration.<br>- Difference in change in QRSarea.<br>- Difference in Q-LV sense.<br>- Difference in pacing threshold.<br>- Difference in % of patients with disappearance of apical rocking.