NCT01777607

Brief Summary

The use of Impella RP is safe, feasible and provides a hemodynamic benefit in patients with right ventricular failure.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 14, 2013

Status Verified

May 1, 2013

Enrollment Period

2.6 years

First QC Date

January 25, 2013

Last Update Submit

May 11, 2013

Conditions

Right Heart Failure

Outcome Measures

Primary Outcomes (1)

  • 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).

    30 Days

Study Arms (1)

Intervention

EXPERIMENTAL
Device: IMPELLA® RP

Interventions

IMPELLA® RPDEVICE
Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

RECRUITING

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26681124DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • William O.Neill, MD

    Henry Ford Hospital

    PRINCIPAL INVESTIGATOR

  • Mark Anderson, MD

    Albert Einstein Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2013

First Posted

January 29, 2013

Study Start

May 1, 2013

Primary Completion

December 1, 2015

Study Completion

June 1, 2016

Last Updated

May 14, 2013

Record last verified: 2013-05

Locations

US(2)