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Advanced Image Supported Lef ventricular Lead Placement in Cardiac Resynchronization Therapy

Advanced Image Supported Lef ventricular Lead Placement in Cardiac Resynchronization Therapy - Advise-CRT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44064
Enrollment
15
Registered
2016-06-08
Start date
2016-10-31
Completion date
Unknown
Last updated
2024-04-23

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

Conditions

cardiac decompensation chronic heart failure

Interventions

In the final review group of 6 patients, the cardiologist will use the 3D venogram and fused MRI and CT images during CRT implantation, to optimize the LV lead position.

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: An indication Cardiac Resynchronization Therapy according to the current international evidence based guidelines for CRT (the 2013 European Society of Cardiology Guidelines for cardiac pacing and cardiac resynchronization therapy): -Chronic heart failure; -New York Heart Association functional class II, III, IV (ambulatory); -QRS duration *120ms; -Optimal pharmacological therapy; -Left ventricular ejection fraction *35%;;And specifically for phase 1 of the study: -Documented history of myocardial infarction, coronary artery disease, or delayed enhancement on a prior MRI.

Exclusion criteria

Exclusion criteria: -Contraindications for implantation of a CRT device; -Age

Design outcomes

Primary

MeasureTime frame
Feasibility - Quality of MRI; - Quality of CT; - Quality of treatment file (CARTBox3); - Quality of 3D venogram; - Fusion feasibility; - Fluoroscopy time; - Contrast dose CT; - Radiation dose CT; - Radiation dose of CRT implantation; - Complications during CRT implantation; - Implantation duration.; - Patient repositioning; - Number of additional 3D images.

Secondary

MeasureTime frame
LV lead parameters (recorded of each possible position). -Lead/electrode position in RAO 30° en LAO 40° view; -Lead/electrode position in 3D view; -Distance of lead/electrode to infarct location; -Distance of lead/electrode to phrenic nerve position; -Distance of lead/electrode to latest activated segment; -Pacing and n. phrenicus threshold; -Type of LV lead; -QLVsense (of each electrode);

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)