Advanced Image Supported Lef ventricular Lead Placement in Cardiac Resynchronization Therapy

Completed

Conditions: cardiac decompensation
chronic heart failure
10019280

Registration Number: NL-OMON44064

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 15

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

-Contraindications for implantation of a CRT device;
-Age <18 years or incapacitated adult;
-Pregnancy; if there is anamnestic doubt regarding postmenopausal state (<1 year since last menstruation), an urine hCG test (Alere) will be performed.
-Lactation;
-Impaired renal function (severe renal insufficiency, GFR < 30 ml/min/1.73m2);
-Permanent atrial fibrillation or atrial fibrillation during MRI
-Documented allergic reaction to gadolinium;
-Documented allergic reaction to contrast agent;
-Impossibility to undergo a MRI scan (determined by using the standard contraindications for MR imaging as used for clinical purposes).
-Participation in another clinical study that prohibits any procedures other than standard. ;After study MRI:
- No delayed enhancement on MRI

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Feasibility<br /><br>- Quality of MRI;<br /><br>- Quality of CT;<br /><br>- Quality of treatment file (CARTBox3);<br /><br>- Quality of 3D venogram;<br /><br>- Fusion feasibility;<br /><br>- Fluoroscopy time;<br /><br>- Contrast dose CT;<br /><br>- Radiation dose CT;<br /><br>- Radiation dose of CRT implantation;<br /><br>- Complications during CRT implantation;<br /><br>- Implantation duration.;<br /><br>- Patient repositioning;<br /><br>- Number of additional 3D images. </p><br>

Secondary Outcome Measures

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