NL-OMON44064
Completed
N/A
Advanced Image Supported Lef ventricular Lead Placement in Cardiac Resynchronization Therapy - Advise-CRT
niversitair Medisch Centrum Utrecht0 sites15 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- cardiac decompensation
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 15
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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:
Outcomes
Primary Outcomes
Not specified
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