NL-OMON54061
Recruiting
N/A
Advanced Image Supported Left Ventricular Lead Placement in Cardiac Resynchronization Therapy III - ADVISE-III
niversitair Medisch Centrum Utrecht0 sites130 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Cardiomyopathy
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 130
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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