Dilated Cardiomyopathy
Conditions
Brief summary
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
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).
Interventions
DEVICERenewal
Renewal is a CRT-D device for cardiac resynchronization therapy
Sponsors
Boston Scientific Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Aortic Velocity Time Integral (VTI) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 6 Minute Walk Test | 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) | implant (baseline), 3 Months, 6 Months | Left ventricular Ejection Fraction (LVEF) was measured before implant (baseline) and at 3 and 6 months Follow-up |
Countries
Denmark
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 | 43 |
| Total | 43 |
Baseline characteristics
| Characteristic | Group 1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 15 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Age, Continuous | 61 years STANDARD_DEVIATION 11 |
| Region of Enrollment Denmark | 43 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 |
Outcome results
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).
Time frame: At implant (baseline), 3 months and 6 months Follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Aortic Velocity Time Integral (VTI) | VTI at baseline intrinsic rhythm | 22.4 cm | Standard Deviation 7.7 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Aortic Velocity Time Integral (VTI) | VTI at baseline intrinsic rhythm + 10 Bpm | 21.7 cm | Standard Deviation 7.7 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Aortic Velocity Time Integral (VTI) | VTI at baseline intrinsic rhythm + 20 Bpm | 19.4 cm | Standard Deviation 7.5 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Aortic Velocity Time Integral (VTI) | VTI at baseline intrinsic rhythm + 30 Bpm | 18.1 cm | Standard Deviation 7.1 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Aortic Velocity Time Integral (VTI) | VTI at 3M Follow-up intrinsic rhythm | 23.6 cm | Standard Deviation 9 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Aortic Velocity Time Integral (VTI) | VTI at 3M Follow-up intrinsic rhythm + 10 Bpm | 21.9 cm | Standard Deviation 9 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Aortic Velocity Time Integral (VTI) | VTI at 3M Follow-up intrinsic rhythm + 20 Bpm | 21.2 cm | Standard Deviation 8.1 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Aortic Velocity Time Integral (VTI) | VTI at 3M Follow-up intrinsic rhythm + 30 Bpm | 19.4 cm | Standard Deviation 8.3 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Aortic Velocity Time Integral (VTI) | VTI at 6M Follow-up intrinsic rhythm | 24.6 cm | Standard Deviation 8.4 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Aortic Velocity Time Integral (VTI) | VTI at 6M Follow-up intrinsic rhythm + 10 Bpm | 23.2 cm | Standard Deviation 7.5 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Aortic Velocity Time Integral (VTI) | VTI at 6M Follow-up intrinsic rhythm + 20 Bpm | 21.7 cm | Standard Deviation 7 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Aortic Velocity Time Integral (VTI) | VTI at 6M Follow-up intrinsic rhythm + 30 Bpm | 20.2 cm | Standard Deviation 7.2 |
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.
Time frame: Implant (baseline), 3 months and 6 months Follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Optimal AV-Delay (AVD) | Optimal AVD at baseline intrinsic rhythm | 115 ms | Standard Deviation 24 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Optimal AV-Delay (AVD) | Optimal AVD at baseline intrinsic rhythm +10Bpm | 119 ms | Standard Deviation 29 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Optimal AV-Delay (AVD) | Optimal AVD at baseline intrinsic rhythm +20Bpm | 123 ms | Standard Deviation 22 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Optimal AV-Delay (AVD) | Optimal AVD at baseline intrinsic rhythm +30Bpm | 127 ms | Standard Deviation 28 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Optimal AV-Delay (AVD) | Optimal AVD at 3M intrinsic rhythm | 117 ms | Standard Deviation 28 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Optimal AV-Delay (AVD) | Optimal AVD at 3M intrinsic rhythm +10Bpm | 117 ms | Standard Deviation 24 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Optimal AV-Delay (AVD) | Optimal AVD at 3M intrinsic rhythm +20Bpm | 127 ms | Standard Deviation 28 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Optimal AV-Delay (AVD) | Optimal AVD at 3M intrinsic rhythm +3Bpm | 119 ms | Standard Deviation 23 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Optimal AV-Delay (AVD) | Optimal AVD at 6M intrinsic rhythm | 115 ms | Standard Deviation 24 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Optimal AV-Delay (AVD) | Optimal AVD at 6M intrinsic rhythm +10Bpm | 132 ms | Standard Deviation 28 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Optimal AV-Delay (AVD) | Optimal AVD at 6M intrinsic rhythm +20Bpm | 130 ms | Standard Deviation 30 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Optimal AV-Delay (AVD) | Optimal AVD at 6M intrinsic rhythm +30Bpm | 130 ms | Standard Deviation 17 |
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.
Time frame: implant (baseline), 3 months and 6 months Follow-up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | 6 Minute Walk Test | 6 MWT at baseline | 388 meter | Standard Error 88 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | 6 Minute Walk Test | 6 MWT at 3M Follow-up | 470 meter | Standard Error 87 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | 6 Minute Walk Test | 6 MWT at 6M Follow-up | 497 meter | Standard Error 83 |
Secondary
Left Ventricular Ejection Fraction (LVEF)
Left ventricular Ejection Fraction (LVEF) was measured before implant (baseline) and at 3 and 6 months Follow-up
Time frame: implant (baseline), 3 Months, 6 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Left Ventricular Ejection Fraction (LVEF) | LVEF at baseline | 21 % of cardiac volume | Standard Deviation 6 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Left Ventricular Ejection Fraction (LVEF) | LVEF at 3M | 24 % of cardiac volume | Standard Deviation 7 |
| Cardiac Resynchronization Therapy ICD (Renewal CRT) | Left Ventricular Ejection Fraction (LVEF) | LVEF at 6M | 24 % of cardiac volume | Standard Deviation 8 |