Optimization of Cardiac Resynchronization Therapy at rest and during exercise conditions.
- Conditions
- heart failureventricular dyssynchrony10019280
- Registration Number
- NL-OMON35451
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 51
Indication for Cardiac Resynchronization Therapy according to the current international guidelines. (See research protocol: chapter 5.2)
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;
-Open operation wound for more than 3 hours before start of dobutamine infusion (only applies to dobutamine infusion during device implantation);
-Contraindications for dobutamine (baseline systolic blood pressure >180 mmHg or <80 mmHg, hemodynamic significant left ventricular outflow tract obstruction, aortic aneurysm, aortic dissection);
-Insufficient image quality during echocardiography at rest (only applies to dobutamine stress echocardiography);
-Experienced secondary endpoint (side effect) during dobutamine stress echocardiography (only applies to dobutamine infusion during device implantation).
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The difference, in milliseconds, between the optimal AVD/VVD during resting<br /><br>conditions versus exercise.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To reach the secondary objectives, the following parameters are also measured:<br /><br>the intrinsic atrio- and interventricular conduction times on the intracardiac<br /><br>electrogram; coronary sinus dP/dt; a matrix with the dP/dt for all possible<br /><br>combinations of AVD*s and VVD*s. Moreover echocardiographic indices of<br /><br>mechanical asynchrony during rest and dobutamine infusion are determined.</p><br>