NL-OMON44474
Completed
N/A
Optimization of Cardiac Resynchronization Therapy with a Quadripolar Left Ventricular Lead - OPTICARE-QLV
niversitair Medisch Centrum Utrecht0 sites60 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Chronic heart failure
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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%.
Exclusion Criteria
- •\- 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).
Outcomes
Primary Outcomes
Not specified
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