NL-OMON35451
Completed
N/A
Optimization of Cardiac Resynchronization Therapy at rest and during exercise conditions. - OPTI-CARE
niversitair Medisch Centrum Utrecht0 sites51 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- niversitair Medisch Centrum Utrecht
- Enrollment
- 51
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Indication for Cardiac Resynchronization Therapy according to the current international guidelines. (See research protocol: chapter 5\.2\)
Exclusion Criteria
- •Criteria for the complete study: (see also research protocol chapter 5\.3\)
- •\-Contraindications for implantation of a CRT device;
- •\-Age \<18 years or incapacitated adult;
- •\-Participation in another clinical study that prohibits any procedures other than standard;
- •\-Pregnancy;
- •\-Severe aortic stenosis with a valve area \<1,0 cm2 or aortic valve replacement in history.;Specific criteria for the infusion of dobutamine (see research protocol chapter 5\.3 and 6\.2\.1\):
- •\-Significant abnormalities on coronary angiogram or myocardial perfusion scan (part of standard procedure before CRT implantation) that are not treated by coronary artery bypass graft or percutaneous coronary intervention;
- •\-Atrial fibrillation with a fast ventricular response (heart rate \>100 bpm);
- •\-Baseline heart rate \<10 beats per minute below target heart rate;
- •\-Sinus bradycardia \<40 beats per minute at baseline;
Outcomes
Primary Outcomes
Not specified
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