Structural and Valvular Heart DiseaseNCT01669551
A Phase 1 Feasbility Study Of Volume Intracardiac Echo In Assessment Of Patients With Structural And Valvular Heart Disease Undergoing Percutaneous Transcatheter Therapy
An observational study of Structural and Valvular Heart Disease, run by University of Pennsylvania.
Trial summary
This study will compare 3 dimensional intracardiac echo (ICE) with 2 dimensional ICE or transesophageal echo in patients with structural and valvular heart disease who are already scheduled to undergo a percutaneous intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Structural and Valvular Heart Disease
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to Dec 2014
- 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 structural or valvular heart disease
Who may be able to join
- patients in the study population referred to the cardiac catheterization laboratory for a percutaneous procedure to treat structural or valvular heart disease
Who cannot join
- Class IV CHF, inadequate femoral access, coagulation abnormalities, intracariac thrombus or DVT
About this study
This study will compare 3 dimensional intracardiac echo (ICE) with 2 dimensional ICE or transesophageal echo in patients with structural and valvular heart disease who are already scheduled to undergo a percutaneous intervention. Specifically those patients would be those scheduled for a PFO or ASD repair, mitral balloon valvuloplasty, diagnostic cardiac catheterization assessment of aortic stenosis and those undergoing transcatheter aortic valve replacement.
- Conditions
- Structural and Valvular Heart Disease
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Structural or Valvular Heart Disease | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of volume intracardiac echo imaging to 2 dimensional echo
Measured: Comparison study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionDec 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 Structural and Valvular Heart DiseaseStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Howard Herrmann, M.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01669551
- Sponsor's protocol ID
- UPenn 815656
- Status last verified
- Aug 2012
- First submitted
- 16 Aug 2012
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Silvestry FE, Kadakia MB, Willhide J, Herrmann HC. Initial experience with a novel real-time three-dimensional intracardiac ultrasound system to guide percutaneous cardiac structural interventions: a phase 1 feasibility study of volume intracardiac echocardiography in the assessment of patients with structural heart disease undergoing percutaneous transcatheter therapy. J Am Soc Echocardiogr. 2014 Sep;27(9):978-83. doi: 10.1016/j.echo.2014.04.022. Epub 2014 Jun 11.
PubMed 24930123Kadakia MB, Silvestry FE, Herrmann HC. Intracardiac echocardiography-guided transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2015 Feb 15;85(3):497-501. doi: 10.1002/ccd.25409. Epub 2014 Feb 10.
PubMed 24478152
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Feasbility Study Of Volume Intracardiac Echo In Assessment Of Patients With Structural And Valvular Heart Disease Undergoing Percutaneous Transcatheter Therapy
- ClinicalTrials.gov ID
- NCT01669551
- Acronym / sponsor ID
- UPenn 815656
- Conditions
- Structural and Valvular Heart Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Aug 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.
This study will compare 3 dimensional intracardiac echo (ICE) with 2 dimensional ICE or transesophageal echo in patients with structural and valvular heart disease who are already scheduled to undergo a percutaneous intervention. Specifically those patients would be those scheduled for a PFO or ASD repair, mitral balloon valvuloplasty, diagnostic cardiac catheterization assessment of aortic stenosis and those undergoing transcatheter aortic valve replacement.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Structural or Valvular Heart Disease | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with structural or valvular heart disease
Key inclusion criteria (1 listed)
- patients in the study population referred to the cardiac catheterization laboratory for a percutaneous procedure to treat structural or valvular heart disease
Key exclusion criteria (1 listed)
- Class IV CHF, inadequate femoral access, coagulation abnormalities, intracariac thrombus or DVT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of volume intracardiac echo imaging to 2 dimensional echo
Time frame: Comparison study
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 10 Dec 2014.
- Derived from this study: PubMed 24930123Silvestry FE, Kadakia MB, Willhide J, Herrmann HC. Initial experience with a novel real-time three-dimensional intracardiac ultrasound system to guide percutaneous cardiac structural interventions: a phase 1 feasibility study of volume intracardiac echocardiography in the assessment of patients with structural heart disease undergoing percutaneous transcatheter therapy. J Am Soc Echocardiogr. 2014 Sep;27(9):978-83. doi: 10.1016/j.echo.2014.04.022. Epub 2014 Jun 11.
- Derived from this study: PubMed 24478152Kadakia MB, Silvestry FE, Herrmann HC. Intracardiac echocardiography-guided transcatheter aortic valve replacement. Catheter Cardiovasc Interv. 2015 Feb 15;85(3):497-501. doi: 10.1002/ccd.25409. Epub 2014 Feb 10.
Related trials for Structural and Valvular Heart Disease
RecruitingObservational study
Prospective Evaluation of AI-ECG for SHD Detection
Valvular Heart Disease Stenosis and Regurgitation (Diagnosis), Pulmonary Hypertension (Diagnosis)
Recruiting
Capitalizing on AI to CapTure Undiagnosed Structural Heart Disease
Structural Heart Abnormality, Valve Heart Disease
Enrolling by invitationPhase 4
Optimal PeriproCeduraL AnticOagulation in Structural Transseptal Interventions
Mitral Regurgitation, Atrial Fibrillation
Enrolling by invitation
ENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation
Aortic Valve Stenosis, Heart Valve Diseases
RecruitingObservational study
Abbott Structural Heart Device Registry
Heart Diseases, ASD - Atrial Septal Defect
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.
Howard Herrmann, M.D. principal investigator
University of Pennsylvania
Questions about this trial
What is this clinical trial studying?
An observational study of Structural and Valvular Heart Disease, run by University of Pennsylvania.
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 1 inclusion and 1 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 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Comparison of volume intracardiac echo imaging to 2 dimensional echo (time frame: Comparison study). 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 NCT01669551, 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 10 Dec 2014.