NCT03117296

Brief Summary

Implementation of Physical Therapy (PT) and Occupational Therapy (OT) pathway (initiation of services on Post procedure day #1 and continued daily with focus on education and activity progression) for all patients undergoing a transcatheter aortic value repair procedure began on December 2, 2014. Retrospective data was collected from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Aortic Valve Replacement Procedures (STS/ACC TVT, trademark) Registry - National database for Transcatherter Aortic Valve Replacement Procedures and included subjects from March 2012 through July 31, 2015. Patients included: s/p tAVR via transfemoral catheter approach, with or without minor intra or post procedure events (GI bleeds, minor access bleeds, afib, etc); Exclusions: Major events including stroke, pacemaker placement, other cardiovascular (CV) repair or surgery required, etc). Future data analysis will extend subjects to December 31, 2015 and annually.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
189

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 3, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2015

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 7, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 17, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
5.1 years until next milestone

Results Posted

Study results publicly available

January 20, 2023

Completed
Last Updated

January 20, 2023

Status Verified

April 1, 2022

Enrollment Period

8 months

First QC Date

April 7, 2017

Results QC Date

February 15, 2022

Last Update Submit

April 18, 2022

Conditions

Transcatheter Aortic Valve Implantation

Keywords

physical therapyoccupational therapytAVR

Outcome Measures

Primary Outcomes (2)

  • Post Procedure Hospital Length of Stay

    From date of procedure until date of hospital discharge, assessed up to 50 days.

    at discharge

  • Total Hospital Length of Stay

    Days from Hospital admission to Hospital Discharge

    at discharge

Secondary Outcomes (2)

  • Discharge Disposition, Home

    on day of hospital discharge

  • Discharge Destination, Rehab Facility

    on day of hospital discharge

Study Arms (2)

Post procedure routine PT and or OT

Routine PT and or OT

Other: Routine PT or OT

Post Procedure PT and OT pathway

Post procedure day zero nursing mobilization; post procedure day one PT and OT assessment and intervention, daily PT and OT intervention

Other: Post procedure daily PT and OTOther: PT post procedureOther: OT post procedure

Interventions

Post procedure daily PT and OTOTHER

PT evaluation and treatment on post procedure day zero: Nurses mobility patient using egress testing one time

Post Procedure PT and OT pathway
PT post procedureOTHER

post procedure day one: PT and OT assessment, education and intervention.

Post Procedure PT and OT pathway
OT post procedureOTHER

PT and OT Daily until goals met or patient discharge.

Post Procedure PT and OT pathway
Routine PT or OTOTHER

Routine PT or OT consulted by physician when identified discharge disposition of home

Post procedure routine PT and or OT

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Consecutive population sample of patients at Henry Ford Hospital, Detroit, Michigan undergoing transcatheter aortic valve replacement via femoral access in cath lab from March 2012 to present.

You may qualify if:

  • admission to henry ford hospital after March 1, 2012
  • status post transcatheter aortic valve replacement via transfemoral catheter approach, with or without minor intra or post procedure events (GI bleeds, minor access bleeds, afib, etc)

You may not qualify if:

  • Occurrence of major events including stroke, pacemaker placement, other CV repair or surgery required, etc)
  • procedure via appropriate other than femoral access (transapical, transcaval)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Related Publications (3)

  • Babaliaros V, Devireddy C, Lerakis S, Leonardi R, Iturra SA, Mavromatis K, Leshnower BG, Guyton RA, Kanitkar M, Keegan P, Simone A, Stewart JP, Ghasemzadeh N, Block P, Thourani VH. Comparison of transfemoral transcatheter aortic valve replacement performed in the catheterization laboratory (minimalist approach) versus hybrid operating room (standard approach): outcomes and cost analysis. JACC Cardiovasc Interv. 2014 Aug;7(8):898-904. doi: 10.1016/j.jcin.2014.04.005. Epub 2014 Jul 30.

    PMID: 25086843BACKGROUND

  • Marcantuono R, Gutsche J, Burke-Julien M, Anwaruddin S, Augoustides JG, Jones D, Mangino-Blanchard L, Hoke N, Houseman S, Li R, Patel P, Stetson R, Walsh E, Szeto WY, Herrmann HC. Rationale, development, implementation, and initial results of a fast track protocol for transfemoral transcatheter aortic valve replacement (TAVR). Catheter Cardiovasc Interv. 2015 Mar;85(4):648-54. doi: 10.1002/ccd.25749. Epub 2014 Nov 29.

    PMID: 25413312BACKGROUND

  • Reardon MJ, Van Mieghem NM, Popma JJ, Kleiman NS, Sondergaard L, Mumtaz M, Adams DH, Deeb GM, Maini B, Gada H, Chetcuti S, Gleason T, Heiser J, Lange R, Merhi W, Oh JK, Olsen PS, Piazza N, Williams M, Windecker S, Yakubov SJ, Grube E, Makkar R, Lee JS, Conte J, Vang E, Nguyen H, Chang Y, Mugglin AS, Serruys PW, Kappetein AP; SURTAVI Investigators. Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2017 Apr 6;376(14):1321-1331. doi: 10.1056/NEJMoa1700456. Epub 2017 Mar 17.

    PMID: 28304219BACKGROUND

Limitations and Caveats

One hospital in one area. Low subject number.

Results Point of Contact

Title
Adele Myszenski, PT, DPT
Organization
Henry Ford Hospital
amyszen1@hfhs.org
313-916-1334

Study Officials

  • Adele Myszenski, MPT

    Henry Ford Health System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Supervisor, Physical Therapist

Study Record Dates

First Submitted

April 7, 2017

First Posted

April 17, 2017

Study Start

December 3, 2014

Primary Completion

July 31, 2015

Study Completion

December 31, 2017

Last Updated

January 20, 2023

Results First Posted

January 20, 2023

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

IRB was closed March 08-2021 and no plans to share data from this preliminary study

Locations

US(1)