ACC - Atrial Contribution to CRT

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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ACC - Atrial Contribution to CRT

Conditions
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Dilated Cardiomyopathy

Intervention / Treatment
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* Device: Renewal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptoms of heart failure Left ventricular dysfunction Ventricular dyssynchrony 18 years or of legal age in order to give informed consent according to national laws Able to understand the nature of the procedure Available for follow-up on a regular basis at an approved investigational center Exclusion Criteria: Atrial Fibrillation Life expectancy of less than six months due to other medical conditions For women: pregnancy or absence of medically accepted birth control Inability or refusal to sign the Patient Informed Consent Inability or refusal to comply with the follow up schedule or protocol requirements Inability to undergo device implant, including general anaesthesia if required Mechanical tricuspid prosthesis Currently enrolled in another investigational study, including drug investigations Hypertrophic Obstructive Cardiomyopathy (HOCM) Not meeting the inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renewal CRT (CRT ICD)<br>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). | Device: Renewal<br>* Renewal is a CRT-D device for cardiac resynchronization therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aortic Velocity Time Integral (VTI) | Velocity time integral of the aortic flow correlates with cardiac output and is an accepted parameter for optimization of Cardiac Resynchronization Therapy (CRT). | At implant (baseline), 3 months and 6 months Follow-up | 
| Optimal AV-Delay (AVD) | 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. | Implant (baseline), 3 months and 6 months Follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 Minute Walk Test | 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. | implant (baseline), 3 months and 6 months Follow-up | 
| Left Ventricular Ejection Fraction (LVEF) | Left ventricular Ejection Fraction (LVEF) was measured before implant (baseline) and at 3 and 6 months Follow-up | implant (baseline), 3 Months, 6 Months |