Rigshospitalet
Copenhagen, Denmark
NCT Number: NCT00180323
This prospective study will evaluate in patients, fulfilling implant criteria for Cardiac Resynchronisation Therapy (CRT) implant, the optimal atrial contribution to the resynchronised ventricles in the event of right atrial pacing.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Copenhagen, Denmark
All patients will undergo advanced echocardiographic examination pre-operative, pre-discharge after implantation and at 3 and 6-months follow-up. AV-delay optimization will be performed using aortic VTI measured by continuous wave Doppler in a modified 4-chamber view. During optimisation aortic VTI will be measured at different heart rates reached by increasing atrial pacing 10, 20 and 30 beats above intrinsic heart rate (IHR).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Renewal is a CRT-D device for cardiac resynchronization therapy
Time frame: At implant (baseline), 3 months and 6 months Follow-up
Velocity time integral of the aortic flow correlates with cardiac output and is an accepted parameter for optimization of Cardiac Resynchronization Therapy (CRT).
Time frame: Implant (baseline), 3 months and 6 months Follow-up
Optimal AV-Delay will be measured at implant (baseline ), 3months and 6 months Follow-up for intrinsic heart rate, and 10, 20 and 30 Bpm above intrinsic heart rate.
Time frame: implant (baseline), 3 months and 6 months Follow-up
6 Minute Walk Test was performed at implant (baseline), 3 months and 6 months follow-up Distance walked within 6 minutes is assessed in meter. This is a test that reflects daily life activities of elderly patients.
Time frame: implant (baseline), 3 Months, 6 Months
Left ventricular Ejection Fraction (LVEF) was measured before implant (baseline) and at 3 and 6 months Follow-up
Boston Scientific Corporation
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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