Right Heart FailureNCT01777607
The Use of Impella RP Support System in Patients With Right Heart Failure
A study testing IMPELLA® RP in people with Right Heart Failure, run by Abiomed Inc. at 2 sites in United States.
Trial summary
The use of Impella RP is safe, feasible and provides a hemodynamic benefit in patients with right ventricular failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Heart Failure
- What is being tested?
- IMPELLA® RP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2013to Jun 2016
- 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
Who may be able to join
- Patients that have developed signs of right ventricular failure either: A) within 48 hours post-implantation of an FDA approved implantable surgical LVAD (left ventricular assist device )(Cohort A) or B) subsequent to postcardiotomy shock within 48 hours post surgery or post myocardial infarction (Cohort B).
- Age ≥18 years old
- Signed Informed consent
Who cannot join
- INTERMACS 1 patients (Critical cardiogenic shock patient who is "crashing and burning", has life-threatening hypotension and rapidly escalating inotropic or pressor support, with critical organ hypoperfusion often confirmed by worsening acidosis and lactate levels)
- Evidence of acute neurologic injury
- RA(right atrium),RV (right Ventricle) and/or PA (pulmonary artery) thrombus
- Intolerance to anticoagulant or antiplatelet therapies
- Existing congenital heart disease that would preclude the insertion of the device.
- Participation in any other clinical investigation that is likely to confound study results or affect study outcome
- Acute Myocardial Infarction (AMI) with mechanical complications ( ventricular septal defect, myocardial rupture, papillary muscle rupture)
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Margaret Fox, RN, 313-916-1879, mfox2@hfhs.org
William O'Neill, MD
- Recruiting
Albert Einstein Medical Center
Philadelphia, Pennsylvania, 19141
Maggie Flynn, 267-421-7439, FlynnMag@einstein.edu
Mark Anderson, MD
About this study
Official title: The Use of Impella RP Support System in Patients With Right Heart Failure: A Clinical and Probable Benefit Study
The use of Impella RP is safe, feasible and provides a hemodynamic benefit in patients with right ventricular failure.
- Conditions
- Right Heart Failure
- Being tested
- IMPELLA® RP
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMPELLA® RPDevice
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Device: IMPELLA® RP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Benefit Endpoint
Survival at 30 days or hospital discharge whichever is longer post device explant or to the next therapy, including transplant, bridge to transplant or destination therapy with FDA approved surgical VAD (Ventricular Assit Device).
Measured: 30 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startMay 2013
- Primary completionDec 2015 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Right Heart FailureStudies of the same condition, open and under way.
- More trials run by Abiomed Inc.The 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abiomed Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William O.Neill, MD, Principal investigator, Henry Ford HospitalMark Anderson, MD, Principal investigator, Albert Einstein Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777607
- Sponsor's protocol ID
- Recover Right
- Status last verified
- May 2013
- First submitted
- 25 Jan 2013
- Last updated
- 14 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Anderson MB, Goldstein J, Milano C, Morris LD, Kormos RL, Bhama J, Kapur NK, Bansal A, Garcia J, Baker JN, Silvestry S, Holman WL, Douglas PS, O'Neill W. Benefits of a novel percutaneous ventricular assist device for right heart failure: The prospective RECOVER RIGHT study of the Impella RP device. J Heart Lung Transplant. 2015 Dec;34(12):1549-60. doi: 10.1016/j.healun.2015.08.018. Epub 2015 Sep 8.
PubMed 26681124
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Impella RP Support System in Patients With Right Heart Failure: A Clinical and Probable Benefit Study
- ClinicalTrials.gov ID
- NCT01777607
- Acronym / sponsor ID
- Recover Right
- Conditions
- Right Heart Failure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Abiomed Inc.Industry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 29 Jan 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 use of Impella RP is safe, feasible and provides a hemodynamic benefit in patients with right ventricular failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: IMPELLA® RP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients that have developed signs of right ventricular failure either: A) within 48 hours post-implantation of an FDA approved implantable surgical LVAD (left ventricular assist device )(Cohort A) or B) subsequent to postcardiotomy shock within 48 hours post surgery or post myocardial infarction (Cohort B).
- Age ≥18 years old
- Signed Informed consent
Key exclusion criteria (7 listed)
- INTERMACS 1 patients (Critical cardiogenic shock patient who is "crashing and burning", has life-threatening hypotension and rapidly escalating inotropic or pressor support, with critical organ hypoperfusion often confirmed by worsening acidosis and lactate levels)
- Evidence of acute neurologic injury
- RA(right atrium),RV (right Ventricle) and/or PA (pulmonary artery) thrombus
- Intolerance to anticoagulant or antiplatelet therapies
- Existing congenital heart disease that would preclude the insertion of the device.
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 |
|---|---|---|
| IMPELLA® RP | Device | Intervention |
Primary outcome
Primary Benefit Endpoint
Time frame: 30 Days
Survival at 30 days or hospital discharge whichever is longer post device explant or to the next therapy, including transplant, bridge to transplant or destination therapy with FDA approved surgical VAD (Ventricular Assit Device).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2013.
- Derived from this study: PubMed 26681124Anderson MB, Goldstein J, Milano C, Morris LD, Kormos RL, Bhama J, Kapur NK, Bansal A, Garcia J, Baker JN, Silvestry S, Holman WL, Douglas PS, O'Neill W. Benefits of a novel percutaneous ventricular assist device for right heart failure: The prospective RECOVER RIGHT study of the Impella RP device. J Heart Lung Transplant. 2015 Dec;34(12):1549-60. doi: 10.1016/j.healun.2015.08.018. Epub 2015 Sep 8.
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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 O.Neill, MD principal investigator
Henry Ford Hospital
Mark Anderson, MD principal investigator
Albert Einstein Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IMPELLA® RP in people with Right Heart Failure, run by Abiomed Inc. at 2 sites 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 14 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Benefit Endpoint (time frame: 30 Days). 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 NCT01777607, which also lists 1 linked publication.
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 May 2013.