Advanced Image Supported Left Ventricular Lead Placement in Cardiac Resynchronization Therapy III

Recruiting

Conditions: Cardiomyopathy
heart failure
10019280
10007593

Registration Number: NL-OMON54061

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 130

Inclusion Criteria

An indication for cardiac resynchronization therapy according to the current
international evidence based guidelines for CRT (the 2016 European Society of
Cardiology Guidelines for Acute and Chronic Heart Failure:
- Chronic heart failure;
- New York Heart Association functional class II, III, IV (ambulatory);
- QRS duration >=130ms;
- Optimal pharmacological therapy;
- Left ventricular ejection fraction <=35%;
- Either a QRS duration >=130ms with left-bundle branch block OR a QRS duration
>=150ms without left-bundle branch block.

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), a urine hCG test (Alere) will be performed.
- 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 a MRI scan (determined by using the standard
contraindications for MR imaging as used for clinical purposes).
- Participation in another clinical study that prohibits or influences any
procedures other than standard.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the distance of the ultimateley selected electrode of a<br /><br>quadripolar LV-lead to a pre-defined target. This will be determined on the<br /><br>basis of a categorical variable and is based on fluroscopic images (LAO 40, RAO<br /><br>30). As a consequence, lead location will be scored as residing within,<br /><br>adjacent to or remote from a pre-defined target, as determined on a 32- and<br /><br>16-segment *bulls eye plot. In addition, LV leads position will be judged for<br /><br>whether it is implanted in scar region (yes/no) and or implanted in a<br /><br>dyssynchronous region (yes/no).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Short term efficacy after 6 months: 1) differences in echocardiographic LV<br /><br>dimensions (end-systolic volume) and function (ejection fraction); 2)<br /><br>proportion of pattients with a structural response, defined as a relative<br /><br>reduction in LV end systolic volume >= 15%.<br /><br><br /><br>2. Short term functional response after 6 months: 1) differences in quality of<br /><br>Life as determined by the Kansas City Cardiomyopathy Questionnaire; 2) New York<br /><br>Heart Association (NYHA) classification and 3) EQ-5D.<br /><br><br /><br>3. Long term efficacy after one and two years: 1) all-cause mortality or heart<br /><br>failure related hospitalisation; 2) clinical composite endpoint of death,<br /><br>transplantation and LV assisting device; 3) functional response determined by a<br /><br>Quality of Life questionnaire; 4) CRT response score.<br /><br><br /><br>4. Total cost of procedure and healthcare costs, using a Health Technology<br /><br>Assessment (HTA) approach.</p><br>