Right Ventricular (RV) DysfunctionBIPACENCT01987531
Temporary Biventricular Pacing
A study testing left ventricular epicardial pacing lead in people with Right Ventricular (RV) Dysfunction, run by University of Pennsylvania at 1 site in United States.
Trial summary
The hypothesis of this study is that temporary biventricular pacing will improve hemodynamic performance in patients with right ventricular dysfunction after open cardiac chamber cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Right Ventricular (RV) Dysfunction
- What is being tested?
- left ventricular epicardial pacing lead
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Feb 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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mitral or tricuspid valve surgery patients identified as having preoperative Right Ventricular dysfunction and Left Ventricular Ejection Fraction less than 45 percent
Who cannot join
- Patients with in-situ biventricular pacemakers
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Hemodynamic Effect of Temporary Biventricular Pacing After Mitral and/or Tricuspid Valve Surgery in Patients With Preoperative Biventricular Dysfunction
The hypothesis of this study is that temporary biventricular pacing will improve hemodynamic performance in patients with right ventricular dysfunction after open cardiac chamber cardiac surgery.
- Conditions
- Right Ventricular (RV) Dysfunction
- Being tested
- left ventricular epicardial pacing lead
- Keywords
- after open cardiac chamber cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
left ventricular epicardial pacing leadOther
| Study group | Role | What they receive |
|---|---|---|
| left ventricular epicardial pacing lead | Experimental | Enrolled patients will have a temporary left ventricular epicardial pacing lead placed in addition to the standard right ventricular and right atrial temporary epicardial pacing leads after open cardiac chamber cardiac surgery. Receives: Other: left ventricular epicardial pacing lead |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular function of the heart
Right Ventricular function is evaluated through combined echocardiographic interventricular synchrony variables which include pulmonary artery catheter derived cardiac index, pulmonary artery (PA) pressure, central venous pressure (CVP), CVP versus PA diastolic pressure, and systolic blood pressure.
Measured: 24 hours after cardiac surgery completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Ventricular (RV) DysfunctionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Vernick, MD, Principal investigator, University of Pennsylvania, Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01987531
- Sponsor's protocol ID
- 816482
- Acronym
- BIPACE
- Status last verified
- Nov 2017
- First submitted
- 5 Nov 2013
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Effect of Temporary Biventricular Pacing After Mitral and/or Tricuspid Valve Surgery in Patients With Preoperative Biventricular Dysfunction
- ClinicalTrials.gov ID
- NCT01987531
- Acronym / sponsor ID
- BIPACE / 816482
- Conditions
- Right Ventricular (RV) Dysfunction
- Keywords
- after open cardiac chamber cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 19 Nov 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.
The hypothesis of this study is that temporary biventricular pacing will improve hemodynamic performance in patients with right ventricular dysfunction after open cardiac chamber cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| left ventricular epicardial pacing lead | Experimental | Other: left ventricular epicardial pacing leadEnrolled patients will have a temporary left ventricular epicardial pacing lead placed in addition to the standard right ventricular and right atrial temporary epicardial pacing leads after open cardiac chamber cardiac surgery. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mitral or tricuspid valve surgery patients identified as having preoperative Right Ventricular dysfunction and Left Ventricular Ejection Fraction less than 45 percent
Key exclusion criteria (2 listed)
- Patients with in-situ biventricular pacemakers
- Pregnant or lactating females
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 |
|---|---|---|
| left ventricular epicardial pacing lead | Other | left ventricular epicardial pacing lead |
Primary outcome
Right ventricular function of the heart
Time frame: 24 hours after cardiac surgery completion
Right Ventricular function is evaluated through combined echocardiographic interventricular synchrony variables which include pulmonary artery catheter derived cardiac index, pulmonary artery (PA) pressure, central venous pressure (CVP), CVP versus PA diastolic pressure, and systolic blood pressure.
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 14 Nov 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.
William Vernick, MD principal investigator
University of Pennsylvania, Anesthesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing left ventricular epicardial pacing lead in people with Right Ventricular (RV) Dysfunction, run by University of Pennsylvania 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?
The sponsor lists 1 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 14 Nov 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 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 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?
Right ventricular function of the heart (time frame: 24 hours after cardiac surgery completion). 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 14 Nov 2017.