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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Renewal CRT (CRT ICD) | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Renewal | Device | Renewal is a CRT-D device for cardiac resynchronization therapy |
|
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jasper Hastrup Svendson, MD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | Denmark |
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Mean | Standard Deviation | cm | At implant (baseline), 3 months and 6 months Follow-up |
|
|
Adverse events were assessed only at implant, 3 months and 6 months follow-up. Events observed between these visits were not provided by the investigator.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jesper Hastrup Svendsen | Rigshospitalet, Copenhagen Unviversity Hospital, Denmark | jesper.hastrup.svendsen@rh.regionh.dk |
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| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
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Left ventricular Ejection Fraction (LVEF) was measured before implant (baseline) and at 3 and 6 months Follow-up |
| implant (baseline), 3 Months, 6 Months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | ms | Implant (baseline), 3 months and 6 months Follow-up |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | meter | implant (baseline), 3 months and 6 months Follow-up |
|
|
|
| Secondary | Left Ventricular Ejection Fraction (LVEF) | Left ventricular Ejection Fraction (LVEF) was measured before implant (baseline) and at 3 and 6 months Follow-up | Posted | Mean | Standard Deviation | % of cardiac volume | implant (baseline), 3 Months, 6 Months |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
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| D000083083 |
| Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Title | Measurements |
|---|---|
|
| Optimal AVD at baseline intrinsic rhythm +30Bpm |
|
| Optimal AVD at 3M intrinsic rhythm |
|
| Optimal AVD at 3M intrinsic rhythm +10Bpm |
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| Optimal AVD at 3M intrinsic rhythm +20Bpm |
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| Optimal AVD at 3M intrinsic rhythm +3Bpm |
|
| Optimal AVD at 6M intrinsic rhythm |
|
| Optimal AVD at 6M intrinsic rhythm +10Bpm |
|
| Optimal AVD at 6M intrinsic rhythm +20Bpm |
|
| Optimal AVD at 6M intrinsic rhythm +30Bpm |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
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