Constrictive PericarditisNCT02027350
New Methods to Diagnose Constrictive Pericarditis
A study testing CD Leycom/Millar Instruments conductance catheter in people with Constrictive Pericarditis, run by Mayo Clinic at 1 site in United States.
Trial summary
Until now, diagnosis of constriction was based on pressure changes of ventricle by conventional pressure-wide hemodynamic evaluation but not on ventricular volume change. This study will provide answers to persisting questions about volume changes during respiration in patients with constrictive pericarditis by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Constrictive Pericarditis
- What is being tested?
- CD Leycom/Millar Instruments conductance catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Nov 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Subjects referred for right and left heart catheterization will be eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Pressure-Volume Analysis of Constrictive Pericarditis
Until now, diagnosis of constriction was based on pressure changes of ventricle by conventional pressure-wide hemodynamic evaluation but not on ventricular volume change. This study will provide answers to persisting questions about volume changes during respiration in patients with constrictive pericarditis by directly measuring both right and left ventricular volume.
- Conditions
- Constrictive Pericarditis
- Being tested
- CD Leycom/Millar Instruments conductance catheter
- Medical subject headings
- Pericarditis, Constrictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD Leycom/Millar Instruments conductance catheterDevice
Conductance catheter-Pressure volume relationship
| Study group | Role | What they receive |
|---|---|---|
| Pressure-volume relationship | Experimental | Changes in pressure-volume relationships will be compared to changes in LV and RV systolic pressure during respiration. Receives: Device: CD Leycom/Millar Instruments conductance catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of constrictive pericarditis
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: due lack of subjects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constrictive PericarditisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barry Borlaug, Mayo Clinic
- Investigators
- Barry Borlaug, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02027350
- Sponsor's protocol ID
- 13-008074
- Status last verified
- Nov 2016
- First submitted
- 31 Dec 2013
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pressure-Volume Analysis of Constrictive Pericarditis
- ClinicalTrials.gov ID
- NCT02027350
- Acronym / sponsor ID
- 13-008074
- Conditions
- Constrictive Pericarditis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: due lack of subjects
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 6 Jan 2014 (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.
Until now, diagnosis of constriction was based on pressure changes of ventricle by conventional pressure-wide hemodynamic evaluation but not on ventricular volume change. This study will provide answers to persisting questions about volume changes during respiration in patients with constrictive pericarditis by directly measuring both right and left ventricular volume.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pressure-volume relationship | Experimental | Device: CD Leycom/Millar Instruments conductance catheterChanges in pressure-volume relationships will be compared to changes in LV and RV systolic pressure during respiration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| CD Leycom/Millar Instruments conductance catheterConductance catheter-Pressure volume relationship | Device | Pressure-volume relationship |
Primary outcome
Presence of constrictive pericarditis
Time frame: 1 hour
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
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.
Barry Borlaug, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CD Leycom/Millar Instruments conductance catheter in people with Constrictive Pericarditis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: withdrawn, as of the sponsor's last update on 4 Nov 2016. 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Presence of constrictive pericarditis (time frame: 1 hour). 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 4 Nov 2016; AzTrials last refreshed its copy on 31 Oct 2026.