Optimization of Cardiac Resynchronization Therapy with a Quadripolar Left Ventricular Lead
- Conditions
- decompensation1001928010007593Chronic heart failure
- Registration Number
- NL-OMON44474
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Patients with 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;
- Left bundle branch block
- Optimal pharmacological therapy;
- Left ventricular ejection fraction *35%.
- Contraindications for implantation of a CRT device;
- Age <18 years or incapacitated adult;
- Pregnancy (clarified in E5);
- Severe aortic valve stenosis with a valve area <1,0 cm2 or aortic valve replacement in history;
- Participation in another clinical study that prohibits any procedures other than standard.
- Permanent atrial fibrillation or atrial fibrillation during CRT implantation;The exclusion criteria regarding the MRI are:
- Lactation;
- Documented allergic reaction to gadolinium;
- Subjects with impaired renal function (severe renal insufficiency, GFR < 30 ml/min/1.73m2);
- Impossibility to undergo a MRI scan (determined by using the standard contraindications for MR imaging as used for clinical purposes).
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The electrical delay at the quadripolar electrodes (expressed as QLVs) and its<br /><br>correlation with the acute hemodynamic response (expressed as %strokework).</p><br>
- Secondary Outcome Measures
Name Time Method