Advanced Image Supported Left Ventricular Lead Placement in Cardiac Resynchronization Therapy (ADVISE-CRT II trial)

Completed

Conditions: Cardiomyopathy
heart failure
10019280
10007593

Registration Number: NL-OMON49313

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

An indication for 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%;

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.
- Subjects with impaired renal function (severe renal insufficiency, GFR < 30
ml/min/1.73m2);
- Atrial fibrillation or atrial fibrillation during MRI
- Lactation;
- 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 or influences any
procedures other than standard.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety: radiation dose during the procedure, (serious) adverse events.<br /><br>Efficacy: LV lead implantation within target (yes/no).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Long-term efficacy: LV end systolic volume reduction assessed by<br /><br>echocardiography at 6 months after the CRT implantation.<br /><br>Feasibility: overall CRT implantation procedure duration, time to perform the<br /><br>placement of the LV lead, preparation time in the Cath lab.<br /><br>Radiation time during the procedure.<br /><br>Validation of 2D image registration compared to 3D image registration.<br /><br>Software usability and feasibility of CARTBox during the lead placement<br /><br>(questionnaire for the operator on the use of CARTBox before and during the LV<br /><br>lead implantation).<br /><br>Measures of acute electrical synchronization (QRS duration, QLVs).<br /><br>Total cost of procedure and healthcare costs, using a Health Technology<br /><br>Assessment (HTA) approach (in cooperation with Julius Clinical, UMC Utrecht).<br /><br>Number of LV leads used, number of LV lead repositioning procedures.</p><br>