Dilated CardiomyopathyNCT00180323
ACC - Atrial Contribution to CRT
A study testing Renewal in people with Dilated Cardiomyopathy, run by Boston Scientific Corporation at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dilated Cardiomyopathy
- What is being tested?
- Renewal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2004to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Mechanical tricuspid prosthesis
- Currently enrolled in another investigational study, including drug investigations
- Hypertrophic Obstructive Cardiomyopathy (HOCM)
- Not meeting the inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Dilated Cardiomyopathy
- Being tested
- Renewal
- Medical subject headings
- Cardiomyopathy, Dilated
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RenewalDevice
Renewal is a CRT-D device for cardiac resynchronization therapy
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Renewal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Implant (baseline), 3 months and 6 months Follow-up
Secondary outcomes (2)
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.
Measured: 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
Measured: implant (baseline), 3 Months, 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startNov 2004
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dilated CardiomyopathyStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jasper Hastrup Svendson, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00180323
- Sponsor's protocol ID
- ACC Version 1.1 11/09/2003
- Status last verified
- Jan 2021
- First submitted
- 12 Sep 2005
- Last updated
- 11 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ACC - Atrial Contribution to CRT
- ClinicalTrials.gov ID
- NCT00180323
- Acronym / sponsor ID
- ACC Version 1.1 11/09/2003
- Conditions
- Dilated Cardiomyopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 12 Nov 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renewal CRT (CRT ICD) | Experimental | Device: RenewalSingle 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RenewalRenewal is a CRT-D device for cardiac resynchronization therapy | Device | Renewal CRT (CRT ICD) |
Primary outcome
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.
2 secondary outcomes
6 Minute Walk Test
Time frame: implant (baseline), 3 months and 6 months Follow-up
Left Ventricular Ejection Fraction (LVEF)
Time frame: implant (baseline), 3 Months, 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jasper Hastrup Svendson, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Renewal in people with Dilated Cardiomyopathy, run by Boston Scientific Corporation at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aortic Velocity Time Integral (VTI) (time frame: At implant (baseline), 3 months and 6 months Follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021; AzTrials last refreshed its copy on 30 Oct 2026.