CCM ImplantationNCT01789112
Acute Effects of a Non Excitatory Cardial Stimulation
A study testing Blood sample in people with CCM Implantation, run by RWTH Aachen University at 1 site in Germany.
Trial summary
Electric stimulation by cardial contractility modulation (CCM)to improve contractility and physical capacity Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- CCM Implantation
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2012to 30 Jun 2017
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- planned CCM Implantation
- systolic left ventricular dysfunction despite of adequate therapy of heart failure (NYHA II, III, IV)
- implanted pacemaker, defibrillator or pacemaker during CS intubation
- written informed consent
- open entryways
Who cannot join
- anemia Hemoglobin (HB)<8 mg/dl
- lying coronary sinus (CS) tube or CS being not able to intubate
- chronic atrial fibrillation or flutter
- mechanic tricuspid valve prothesis
- no access via subclavian vein
- patients with VVI pacemaker being stimulated 110%
Show all 19Show fewer
- idiopathic hypertrophic cardiomyopathy, restrictive constrictive cardiomyopathy or heart failure because of known inflammatory or infiltrative illnesses or constrictive illness
- acute myocardial ischemia presented by angina pectoris or ECG changes under load
- patients being hospitalized because of heart failure during the last month and have to be treated with intravenous diuretics or inotropic substances
- acute coronary syndrome should not be implanted for at least 3 month
- patients with mechanic aortic or tricuspid valve
- patients after heart transplantation
- patients with clinical significant ectopy, defined by > 8.900 PVCs during 24 hours at beginning Holter monitoring
- patients after hypertensive crisis
- patients with acute renal failure
- Ejection Fraction (EF) > 35
- patients after left ventricular pacemaker electrode
- pregnant or breast feeding women
- patients with heart failure after sepsis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Neurotrophic Effects of a Non Excitatory Cardial Stimulation by Optimizer III System in Patients With Heart Failure
Electric stimulation by cardial contractility modulation (CCM)to improve contractility and physical capacity
- Conditions
- CCM Implantation
- Being tested
- Blood sample
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleOther
Taking of blood sample
| Study group | Role | What they receive |
|---|---|---|
| CCM aggregate | Experimental | Taking of 10 blood samples Receives: Other: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
positive inotropic effects by CCM stimulation
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startJul 2012
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CCM ImplantationStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastian Reith, MD, Principal investigator, RWTH Aachen, Medical Departement I Univerity Hospital Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789112
- Sponsor's protocol ID
- 12-032
- Status last verified
- Jul 2018
- First submitted
- 8 Feb 2013
- Last updated
- 6 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Neurotrophic Effects of a Non Excitatory Cardial Stimulation by Optimizer III System in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT01789112
- Acronym / sponsor ID
- 12-032
- Conditions
- CCM Implantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Jul 2012 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 11 Feb 2013 (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.
Electric stimulation by cardial contractility modulation (CCM)to improve contractility and physical capacity
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CCM aggregate | Experimental | Other: Blood sampleTaking of 10 blood samples |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- planned CCM Implantation
- systolic left ventricular dysfunction despite of adequate therapy of heart failure (NYHA II, III, IV)
- implanted pacemaker, defibrillator or pacemaker during CS intubation
- written informed consent
- open entryways
Key exclusion criteria (19 listed)
- anemia Hemoglobin (HB)<8 mg/dl
- lying coronary sinus (CS) tube or CS being not able to intubate
- chronic atrial fibrillation or flutter
- mechanic tricuspid valve prothesis
- no access via subclavian vein
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 |
|---|---|---|
| Blood sampleTaking of blood sample | Other | CCM aggregate |
Primary outcome
positive inotropic effects by CCM stimulation
Time frame: 15 minutes
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 6 Jul 2018.
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.
Sebastian Reith, MD principal investigator
RWTH Aachen, Medical Departement I Univerity Hospital Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with CCM Implantation, run by RWTH Aachen University 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 19 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 6 Jul 2018. 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?
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?
positive inotropic effects by CCM stimulation (time frame: 15 minutes). 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 6 Jul 2018.