Transfemoral Implantation of Aortic ValvesNCT01420484
CNAP in Heart Surgery
An observational study of Transfemoral Implantation of Aortic Valves, run by Heidelberg University at 1 site in Germany.
Trial summary
The role of continuous non-invasive arterial pressure (CNAP) in high risk patients with pronounced variation of arterial pressure will be assessed under analgosedation. Therefore, patients will be analyzed during normo-, hypo- and hypertension with standard IAP undergoing elective transfemoral aortic valve… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transfemoral Implantation of Aortic Valves
- What is being tested?
- different blood pressure intervals
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2010to Dec 2013
- 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 admitted for elective transfemoral implantation of the aortic valve in analgosedation will be included. The patients' primary diagnosis was severe aortic stenosis, that was defined as a valve area of <1cm² or a mean pressure gradient >50mmHg. Exclusion criteria for the study will be an advanced dysfunction of peripheral perfusion (i.e. pronounced arterial peripheral artery occlusive disease or Raynaud's syndrome), arterio-venous shunts for haemodialysis, and vascular surgery of the upper extremities. Before including patients in the present study, blood pressure will be measured on both arms noninvasively by oscillometry to exclude any significant arterial stenosis between the upper extremities. Differences of less than 10 mmHg will be accepted. All patients won't receive any sedative drugs preoperatively and were allowed to drink fluids up to 2 hours before surgery.
Who may be able to join
- Patients admitted for elective transfemoral implantation of the aortic valve in analgosedation will be included.
- The patients' primary diagnosis was severe aortic stenosis, that was defined as a valve area of <1cm² or a mean pressure gradient >50mmHg.
Who cannot join
- an advanced dysfunction of peripheral perfusion (i.e. pronounced arterial peripheral artery occlusive disease or Raynaud's syndrome)
- arterio-venous shunts for haemodialysis, and vascular surgery of the upper extremities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Noninvasive Blood Pressure Measuring
The role of continuous non-invasive arterial pressure (CNAP) in high risk patients with pronounced variation of arterial pressure will be assessed under analgosedation.
Therefore, patients will be analyzed during normo-, hypo- and hypertension with standard IAP undergoing elective transfemoral aortic valve implantation procedures. Systolic, diastolic, and mean invasive arterial pressures (IAP) will be compared to those obtained by CNAP. Data will be analysed in different periods of arterial pressure for agreement of the two methods and for determination of precision (i.e. measurement error) and accuracy (i.e. systematic error). Additionally, we will compare both methods regarding the amplitude and time of very fast changes in arterial pressure during intervals of functional cardiac arrests (rapid pacing).
- Being tested
- different blood pressure intervals
- Keywords
- CNAP, continuous non-invasive arterial pressure, IAP, blood pressure, analgosedation, high-risk patients, rapid-pacing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different blood pressure intervalsOther
In differnent blood presure intervals the IAP and CNAP measurement differences will be observed.
| Study group | Role | What they receive |
|---|---|---|
| different blood pressure intervals | Not described Receives: Other: different blood pressure intervals |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
Measured: blood pressure
Secondary outcomes (1)
age
descriptive data
Measured: age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2011 (estimated)
- Study startJan 2010
- Primary completionOct 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transfemoral Implantation of Aortic ValvesStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heidelberg University
- Sponsor type
- University, hospital or other
- Collaborators
- CNSystems Medizintechnik AG
- Responsible party
- Principal investigator, Konstanze Plaschke, Heidelberg University
- Investigators
- Christoph Schramm, MD, Principal investigator, Department of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01420484
- Sponsor's protocol ID
- S234/2009
- Status last verified
- Dec 2013
- First submitted
- 18 Aug 2011
- Last updated
- 19 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Blood Pressure Measuring
- ClinicalTrials.gov ID
- NCT01420484
- Acronym / sponsor ID
- S234/2009
- Keywords
- CNAP, continuous non-invasive arterial pressure, IAP, blood pressure, analgosedation, high-risk patients, rapid-pacing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Heidelberg UniversityUniversity, hospital or other
- Collaborators
- CNSystems Medizintechnik AG
- Study start
- Jan 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 Aug 2011 (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 role of continuous non-invasive arterial pressure (CNAP) in high risk patients with pronounced variation of arterial pressure will be assessed under analgosedation.
Therefore, patients will be analyzed during normo-, hypo- and hypertension with standard IAP undergoing elective transfemoral aortic valve implantation procedures. Systolic, diastolic, and mean invasive arterial pressures (IAP) will be compared to those obtained by CNAP. Data will be analysed in different periods of arterial pressure for agreement of the two methods and for determination of precision (i.e. measurement error) and accuracy (i.e. systematic error). Additionally, we will compare both methods regarding the amplitude and time of very fast changes in arterial pressure during intervals of functional cardiac arrests (rapid pacing).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| different blood pressure intervals | – | Other: different blood pressure intervals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted for elective transfemoral implantation of the aortic valve in analgosedation will be included. The patients' primary diagnosis was severe aortic stenosis, that was defined as a valve area of <1cm² or a mean pressure gradient >50mmHg. Exclusion criteria for the study will be an advanced dysfunction of peripheral perfusion (i.e. pronounced arterial peripheral artery occlusive disease or Raynaud's syndrome), arterio-venous shunts for haemodialysis, and vascular surgery of the upper extremities. Before including patients in the present study, blood pressure will be measured on both arms noninvasively by oscillometry to exclude any significant arterial stenosis between the upper extremities. Differences of less than 10 mmHg will be accepted. All patients won't receive any sedative drugs preoperatively and were allowed to drink fluids up to 2 hours before surgery.
Key inclusion criteria (2 listed)
- Patients admitted for elective transfemoral implantation of the aortic valve in analgosedation will be included.
- The patients' primary diagnosis was severe aortic stenosis, that was defined as a valve area of <1cm² or a mean pressure gradient >50mmHg.
Key exclusion criteria (2 listed)
- an advanced dysfunction of peripheral perfusion (i.e. pronounced arterial peripheral artery occlusive disease or Raynaud's syndrome)
- arterio-venous shunts for haemodialysis, and vascular surgery of the upper extremities
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 |
|---|---|---|
| different blood pressure intervalsIn differnent blood presure intervals the IAP and CNAP measurement differences will be observed. | Other | different blood pressure intervals |
Primary outcome
blood pressure
Time frame: blood pressure
1 secondary outcome
age
Time frame: age
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 19 Dec 2013.
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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.
Christoph Schramm, MD principal investigator
Department of Anesthesiology
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 Transfemoral Implantation of Aortic Valves, run by Heidelberg 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 2 inclusion and 2 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 19 Dec 2013. 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?
blood pressure (time frame: blood pressure). 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 19 Dec 2013.