Congestive Heart FailureNCT02545582
VITARIA Registry Study
An observational study of Congestive Heart Failure, run by Cyberonics, Inc. at 1 site in Germany.
Trial summary
This registry will observe patients with symptomatic heart failure with implantable vagus nerve stimulation to provide insights into safety and efficacy during clinical routine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure
- What is being tested?
- VITARIA System
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2015to Dec 2019
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with symptomatic heart failure, NYHA class II/III with LVEF≤40%
Who may be able to join
- Willing and capable of providing informed consent according to national data privacy regulations
- Patients with NYHA class II/III
- LVEF≤40% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging, documented less than 12 weeks before implantation of VITARIA system
- Receiving optimal pharmacological heart failure therapy for at least 3 months
- Recent implantation of the VITARIA system, prior to device activation
Who cannot join
- Hospitalization for heart failure and/or required the use of Heart Failure intravenous therapy in the past 30 days
- Severe mitral and/or any aortic valve dysfunction
- History of acute coronary syndrome (ACS) in the past 90 days
- Stroke or transient ischemic attack (TIA) in the past 90 days
- Coronary Artery Bypass Surgery (CABG) in the past 90 days
- PCI in the past 90 days
Show all 13Show fewer
- Surgery for Valve replacement (Aortic or mitral valve) in the past 90 days
- Left ventricular end diastolic diameter (LVEDD) > 80 mm
- Patients who have had a cardiac resynchronization therapy (CRT) device implanted and have been actively treated with CRT for < 12 months
- Patients that are scheduled for CRT
- Patients who are listed for heart transplant or expected to be candidates for heart transplant
- Patients on hemodialysis or peritoneal dialysis
- Patients with diabetes (type I or type II) that is being medically treated for autonomic or sensory neuropathy, or measured hemoglobin A1c (HbA1c) above 8.0% in the past 3 months
Trial locations and contacts
1 site in 1 country.
About this study
This registry will observe patients with symptomatic heart failure with implantable vagus nerve stimulation to provide insights into safety and efficacy during clinical routine.
Read the detailed description
Observational prospective clinical registry in patients with symptomatic heart failure and implanted with the VITARIA System. Assessments will be made during 12 months of post-titration chronic stimulation. The registry will collect patient- and device follow-up data in clinical routine practice at baseline, 3, 6 and 12 months. Clinical routine safety of the therapy will be assessed by the incidence of procedure and device-related events. Clinical routine efficacy will be assessed by changes in cardiac function and heart failure symptoms.
- Conditions
- Congestive Heart Failure
- Being tested
- VITARIA 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.
VITARIA SystemDevice
Implantable vagus nerve stimulator
| Study group | Role | What they receive |
|---|---|---|
| Therapy | Heart failure patients implanted with the VITARIA system Receives: Device: VITARIA System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Serious and non-serious adverse events, according to ISO 14155
Measured: 12 months
LVEF
Left ventricular ejection fraction
Measured: 12 months
Secondary outcomes (6)
LVESV
Left ventricular end-systolic volume
Measured: 12 months
LVESV Index
Left ventricular end-systolic volume index
Measured: 12 months
NYHA Class
New York Heart Association classification
Measured: 12 months
Quality of Life
Minnesota Living with Heart Failure Questionnaire
Measured: 12 months
Heart Rate
Mean heart rate, 24-hour ambulatory ECG
Measured: 12 months
Heart Rate Variability
SDNN, 24-hour ambulatory ECG
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionAug 2018 (estimated)
- Study completionDec 2019 (estimated)
Why it stopped: Sponsor decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Cyberonics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Helmut Klein, MD, Principal investigator, CRI GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02545582
- Sponsor's protocol ID
- C-05
- Status last verified
- Mar 2016
- First submitted
- 8 Sep 2015
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VITARIA Registry Study
- ClinicalTrials.gov ID
- NCT02545582
- Acronym / sponsor ID
- C-05
- Conditions
- Congestive Heart Failure
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Sponsor decision
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cyberonics, Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2015
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 10 Sep 2015 (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.
This registry will observe patients with symptomatic heart failure with implantable vagus nerve stimulation to provide insights into safety and efficacy during clinical routine.
Detailed description
Observational prospective clinical registry in patients with symptomatic heart failure and implanted with the VITARIA System. Assessments will be made during 12 months of post-titration chronic stimulation. The registry will collect patient- and device follow-up data in clinical routine practice at baseline, 3, 6 and 12 months. Clinical routine safety of the therapy will be assessed by the incidence of procedure and device-related events. Clinical routine efficacy will be assessed by changes in cardiac function and heart failure symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Therapy | – | Device: VITARIA SystemHeart failure patients implanted with the VITARIA system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic heart failure, NYHA class II/III with LVEF≤40%
Key inclusion criteria (5 listed)
- Willing and capable of providing informed consent according to national data privacy regulations
- Patients with NYHA class II/III
- LVEF≤40% by imaging method such as echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging, documented less than 12 weeks before implantation of VITARIA system
- Receiving optimal pharmacological heart failure therapy for at least 3 months
- Recent implantation of the VITARIA system, prior to device activation
Key exclusion criteria (13 listed)
- Hospitalization for heart failure and/or required the use of Heart Failure intravenous therapy in the past 30 days
- Severe mitral and/or any aortic valve dysfunction
- History of acute coronary syndrome (ACS) in the past 90 days
- Stroke or transient ischemic attack (TIA) in the past 90 days
- Coronary Artery Bypass Surgery (CABG) in the past 90 days
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 |
|---|---|---|
| VITARIA SystemImplantable vagus nerve stimulator | Device | Therapy |
Primary outcome
Adverse Events
Time frame: 12 months
Serious and non-serious adverse events, according to ISO 14155
LVEF
Time frame: 12 months
Left ventricular ejection fraction
6 secondary outcomes
LVESV
Time frame: 12 months
LVESV Index
Time frame: 12 months
NYHA Class
Time frame: 12 months
Quality of Life
Time frame: 12 months
Heart Rate
Time frame: 12 months
Heart Rate Variability
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
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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.
Helmut Klein, MD principal investigator
CRI GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure, run by Cyberonics, Inc. at 1 site in Germany.
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 5 inclusion and 13 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: paused, as of the sponsor's last update on 31 Jan 2017. 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 Germany. 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?
Results are not available in the source record.
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?
Adverse Events (time frame: 12 months). 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 31 Jan 2017.