ACC - Atrial Contribution to CRT
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|ClinicalTrials.gov Identifier: NCT00180323|
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : November 12, 2012
Last Update Posted : February 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Dilated Cardiomyopathy||Device: Renewal||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||ACC - Atrial Contribution to CRT|
|Study Start Date :||November 2004|
|Primary Completion Date :||December 2008|
|Study Completion Date :||December 2008|
Experimental: Renewal CRT (CRT ICD)
Single arm study only. 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 (Velocity Time Integral) 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).
Renewal is a CRT-D device for cardiac resynchronization therapy
- Aortic Velocity Time Integral (VTI) [ 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).
- Optimal AV-Delay (AVD) [ 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.
- 6 Minute Walk Test [ 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.
- Left Ventricular Ejection Fraction (LVEF) [ 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00180323
|Principal Investigator:||Jasper Hastrup Svendson, MD||Rigshospitalet, Denmark|