Advanced Image Supported Lead Placement in Cardiac Resynchronization Therapy

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29327

Enrollment

130

Registered

2020-05-26

Start date

2021-02-08

Completion date

Unknown

Last updated

2024-06-11

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

Conditions

Chronic heart failure with a reduced ejection fraction and dyssynchrony

Interventions

Real-time cardiac Magnetic Resonance-guided lead implantation by CARTBox.

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Differences in % of patients with succesfull LV lead location between intervention and control group.	—

Secondary

Measure	Time frame
Secondary Outcomes: - Change in LV end-systolic volume, and proportion of volumetric response. - Change in EQ-5D-5L, a quality of life questionnaire. - Change in Kansas City Cardiomyopathy Questionnaire, a quality of life questionnaire. - 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. - Health Technology Assessment. Other Outcomes: - Difference in total implantation procedure time. - Difference in total fluoroscopy time during procedure. - Difference in total contrast dose used during procedure. - Difference in change in QRS duration. - Difference in change in QRSarea. - Difference in Q-LV sense. - Difference in pacing threshold. - Difference in % of patients with disappearance of apical rocking.	—

Measure

Time frame

Secondary Outcomes: - Change in LV end-systolic volume, and proportion of volumetric response. - Change in EQ-5D-5L, a quality of life questionnaire. - Change in Kansas City Cardiomyopathy Questionnaire, a quality of life questionnaire. - 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. - Health Technology Assessment. Other Outcomes: - Difference in total implantation procedure time. - Difference in total fluoroscopy time during procedure. - Difference in total contrast dose used during procedure. - Difference in change in QRS duration. - Difference in change in QRSarea. - Difference in Q-LV sense. - Difference in pacing threshold. - Difference in % of patients with disappearance of apical rocking.

—

Contacts

Public ContactPhilippe Wouters

UMC Utrecht

p.wouters@umcutrecht.nl+31 88 75 743 75

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)