Heart FailureNCT01570517
Feasibility Trial of the DC Devices Interatrial Septal Device (IASD) System
A study testing IASD System in people with Heart Failure, run by Corvia Medical at 3 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the safety and potential benefits of the interatrial septal defect (IASD) System in patients with heart failure with preserved ejection fraction. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- IASD System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 3 sitesin 3 countries
- Study dates
- May 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of HFpEF
- Ejection Fraction of at least 45%
- Imaging and hemodynamic evidence of HFpEF
- History of exercise intolerance
- Symptomatic despite optimal medical management
- Signed study specific informed consent
Who cannot join
- History of thromboembolic events
- Significant structural heart disease or coronary artery disease
- Contraindicated to study required medication
- Right ventricular dysfunction
- History of greater than mild restrictive or obstructive lung disease
- Life expectancy less than one year for non-cardiovascular reasons
- Known or suspected allergy to implant material
- Fertile women
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Evaluation of the DC Devices IASD System in the Treatment of Patients With Heart Failure With Preserved Ejection Fraction
The purpose of this study is to evaluate the safety and potential benefits of the interatrial septal defect (IASD) System in patients with heart failure with preserved ejection fraction.
Read the detailed description
The study was a multi-center, non-randomized feasibility evaluation of the IASD System at three centers in three countries (Denmark, Australia, and Czech Republic). Relevant ethics committee and competent authority approvals were obtained. The study was conducted in accordance with the Declaration of Helsinki. The protocol required the treatment of a minimum of 5 patients, and allowed up to twenty patients to be enrolled.
The primary objective of the trial was to evaluate the safety and potential benefits of the IASD Device System in the treatment of patients with symptomatic heart failure with preserved ejection fraction, despite optimal medical management.
- Conditions
- Heart Failure
- Being tested
- IASD System
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IASD SystemDevice
Implantation of the DC Devices Inc. IASD System
| Study group | Role | What they receive |
|---|---|---|
| Device implantation | Experimental | Subjects are implanted with the study device. Receives: Device: IASD System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Device Events
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startMay 2012
- Primary completionOct 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- 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
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corvia Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Komtebedde, DVM, Study chair, DC Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570517
- Sponsor's protocol ID
- 2011-01
- Status last verified
- Jul 2020
- First submitted
- 21 Mar 2012
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Sondergaard L, Reddy V, Kaye D, Malek F, Walton A, Mates M, Franzen O, Neuzil P, Ihlemann N, Gustafsson F. Transcatheter treatment of heart failure with preserved or mildly reduced ejection fraction using a novel interatrial implant to lower left atrial pressure. Eur J Heart Fail. 2014 Jul;16(7):796-801. doi: 10.1002/ejhf.111. Epub 2014 Jun 24.
PubMed 24961390Malek F, Neuzil P, Gustafsson F, Kaye DM, Walton A, Mates M, Sondergaard L, Ihlemann N, Mariani JA, Reddy V. Clinical outcome of transcatheter treatment of heart failure with preserved or mildly reduced ejection fraction using a novel implant. Int J Cardiol. 2015;187:227-8. doi: 10.1016/j.ijcard.2015.03.198. Epub 2015 Mar 18. No abstract available.
PubMed 25841123
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the DC Devices IASD System in the Treatment of Patients With Heart Failure With Preserved Ejection Fraction
- ClinicalTrials.gov ID
- NCT01570517
- Acronym / sponsor ID
- 2011-01
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Corvia MedicalIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 4 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and potential benefits of the interatrial septal defect (IASD) System in patients with heart failure with preserved ejection fraction.
Detailed description
The study was a multi-center, non-randomized feasibility evaluation of the IASD System at three centers in three countries (Denmark, Australia, and Czech Republic). Relevant ethics committee and competent authority approvals were obtained. The study was conducted in accordance with the Declaration of Helsinki. The protocol required the treatment of a minimum of 5 patients, and allowed up to twenty patients to be enrolled.
The primary objective of the trial was to evaluate the safety and potential benefits of the IASD Device System in the treatment of patients with symptomatic heart failure with preserved ejection fraction, despite optimal medical management.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device implantation | Experimental | Device: IASD SystemSubjects are implanted with the study device. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of HFpEF
- Ejection Fraction of at least 45%
- Imaging and hemodynamic evidence of HFpEF
- History of exercise intolerance
- Symptomatic despite optimal medical management
Key exclusion criteria (8 listed)
- History of thromboembolic events
- Significant structural heart disease or coronary artery disease
- Contraindicated to study required medication
- Right ventricular dysfunction
- History of greater than mild restrictive or obstructive lung disease
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 |
|---|---|---|
| IASD SystemImplantation of the DC Devices Inc. IASD System | Device | Device implantation |
Primary outcome
Serious Adverse Device Events
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Results publication: PubMed 24961390Sondergaard L, Reddy V, Kaye D, Malek F, Walton A, Mates M, Franzen O, Neuzil P, Ihlemann N, Gustafsson F. Transcatheter treatment of heart failure with preserved or mildly reduced ejection fraction using a novel interatrial implant to lower left atrial pressure. Eur J Heart Fail. 2014 Jul;16(7):796-801. doi: 10.1002/ejhf.111. Epub 2014 Jun 24.
- Results publication: PubMed 25841123Malek F, Neuzil P, Gustafsson F, Kaye DM, Walton A, Mates M, Sondergaard L, Ihlemann N, Mariani JA, Reddy V. Clinical outcome of transcatheter treatment of heart failure with preserved or mildly reduced ejection fraction using a novel implant. Int J Cardiol. 2015;187:227-8. doi: 10.1016/j.ijcard.2015.03.198. Epub 2015 Mar 18. No abstract available.
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Jan Komtebedde, DVM study chair
DC Devices
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IASD System in people with Heart Failure, run by Corvia Medical at 3 sites in 3 countries.
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 8 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 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia, Czechia, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serious Adverse Device Events (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01570517, which also lists 2 linked publications.
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 15 Jul 2020.