Back to resultsACC - Atrial Contribution to CRT
Primary Purpose
Dilated Cardiomyopathy
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Renewal
Sponsored by
About this trial
This is an interventional treatment trial for Dilated Cardiomyopathy
Eligibility Criteria
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
Sites / Locations
- Rigshospitalet
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Renewal CRT (CRT ICD)
Arm Description
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).
Outcomes
Primary Outcome Measures
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).
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.
Secondary Outcome Measures
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.
Left Ventricular Ejection Fraction (LVEF)
Left ventricular Ejection Fraction (LVEF) was measured before implant (baseline) and at 3 and 6 months Follow-up
Full Information
NCT ID
NCT00180323
First Posted
September 12, 2005
Last Updated
January 27, 2021
Sponsor
Boston Scientific Corporation
1. Study Identification
Unique Protocol Identification Number
NCT00180323
Brief Title
ACC - Atrial Contribution to CRT
Official Title
ACC - Atrial Contribution to CRT
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dilated Cardiomyopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Renewal CRT (CRT ICD)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Renewal
Intervention Description
Renewal is a CRT-D device for cardiac resynchronization therapy
Primary Outcome Measure Information:
Title
Aortic Velocity Time Integral (VTI)
Description
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
Title
Optimal AV-Delay (AVD)
Description
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
Secondary Outcome Measure Information:
Title
6 Minute Walk Test
Description
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
Title
Left Ventricular Ejection Fraction (LVEF)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jasper Hastrup Svendson, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
12. IPD Sharing Statement
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ACC - Atrial Contribution to CRT
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