Transcatheter Aortic Valve ImplantationPTOTtAVRNCT03117296
Physical Therapy and Occupational Therapy After Transcatheter Aortic Valve Replacement
An observational study of Transcatheter Aortic Valve Implantation, run by Henry Ford Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Transcatheter Aortic Valve Implantation
- What is being tested?
- Post procedure daily PT and OT, PT post procedure and OT post procedure
- How many people
- 189 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2014to 31 Dec 2017
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Occurrence of major events including stroke, pacemaker placement, other CV repair or surgery required, etc)
- procedure via appropriate other than femoral access (transapical, transcaval)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Rationale: Frequency of transcatheter and other structural heart procedures increased dramatically from 2012 to 2014 and is trending even higher for 2015. Procedures increased from 15 in 2012 to 50 cases in 2013 (233% increase) and to 70 cases in 2014 (40% increase from 2013 to 2014.) -- PT and OT identified a gap in consults and need for specific education targeted for a new surgery population (tAVR) without sternotomy. Often consults were placed on day of discharge to rehab facility or not at all. -- Structural Heart division of CV institute identified increased length of stay (LOS) and decreased activity of their patients in the hospital. -- No literature on this subject found via Henry Ford Hospital Sladen Library PubMed literature review
Aim: • Create a standardized pathway for new transcatheter aortic valve replacement patients in the Structural Heart Division (SHD)
- Improve patient outcomes including increasing the percentage of patients returning to home rather than a rehab facility destination at discharge
- Decrease length of stay
Implementation:
- Plan: PT and OT identified a gap in consults and need for specific education targeted at a new surgeries population (tAVR); Structural Heart division of CV institute identified an increase LOS and decreased activity of their patients in the hospital. In October 2014 planning began to introduce a SHD tAVR pathway that would include post procedure day number 0 nursing requirements and training, post procedure day number 1-3 PT and OT assessment and interventions.
- Do: Implemented pathway in November 2014.
- Check: Order set revision; Patient handouts ; Cardiac Rehab; Weekend criteria; staff training
- Act: February 2015, order sets in place, patient handouts finalized and full pathway finalized for post op tAVR patients.
- Continued checks identified additional SHD procedures and team determined that Mitral Clips and LARIATs were not criteria for tAVR pathway but would receive routine PT and OT consults.
Intervention: • Added PT and OT to Structural Heart Order Set.
- PT and OT assessments completed on post procedure day number day 1.
- PT and OT follow up treatments post procedure day number 2, 3 and beyond as appropriate.
- Patient education handouts individualized for patient population
- Pre-op education handouts individualized for patient population
Outcome measures: Hospital Length of stay, discharge disposition. Data Analysis: Chi-square tests are used to compare proportions between groups, while Wilcoxon two-sample tests are used to compare distributions of continuous variables between groups. This nonparametric test was chosen due to non-Gaussian distribution of the continuous outcomes within groups. Statistical significance was set at p<0.05. All analyses were performed using SAS 9.4 (SAS Institute Inc, Cary, North Carolina, USA).
- Conditions
- Transcatheter Aortic Valve Implantation
- Being tested
- Post procedure daily PT and OT, PT post procedure, OT post procedure, Routine PT or OT
- Keywords
- physical therapy, occupational therapy, tAVR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post procedure daily PT and OTOther
PT evaluation and treatment on post procedure day zero: Nurses mobility patient using egress testing one time
PT post procedureOther
post procedure day one: PT and OT assessment, education and intervention.
OT post procedureOther
PT and OT Daily until goals met or patient discharge.
Routine PT or OTOther
Routine PT or OT consulted by physician when identified discharge disposition of home
| Study group | Role | What they receive |
|---|---|---|
| Post procedure routine PT and or OT | Routine PT and or OT Receives: 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 Receives: Other: Post procedure daily PT and OT; Other: PT post procedure; Other: OT post procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Procedure Hospital Length of Stay
From date of procedure until date of hospital discharge, assessed up to 50 days.
Measured: at discharge
Total Hospital Length of Stay
Days from Hospital admission to Hospital Discharge
Measured: at discharge
Secondary outcomes (2)
Discharge Disposition, Home
Discharge destination at discharge. Home includes those discharge home, Home with assistance or Home with Home care.
Measured: on day of hospital discharge
Discharge Destination, Rehab Facility
At hospital discharge, did the patient return Home or were they discharged to a post-acute care Rehab Facility
Measured: on day of hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2017
- Study start3 Dec 2014
- Primary completion31 Jul 2015
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Transcatheter Aortic Valve ImplantationStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 189 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Henry Ford Hospital
- Responsible party
- Principal investigator, Adele Myszenski, Henry Ford Health System
- Investigators
- Adele Myszenski, MPT, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03117296
- Sponsor's protocol ID
- 10437
- Acronym
- PTOTtAVR
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2017
- Last updated
- 20 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IRB was closed March 08-2021 and no plans to share data from this preliminary study
Publications
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.
PubMed 25086843Marcantuono 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.
PubMed 25413312Reardon 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.
PubMed 28304219
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Therapy and Occupational Therapy After Transcatheter Aortic Valve Replacement
- ClinicalTrials.gov ID
- NCT03117296
- Acronym / sponsor ID
- PTOTtAVR / 10437
- Conditions
- Transcatheter Aortic Valve Implantation
- Keywords
- physical therapy, occupational therapy, tAVR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Collaborators
- Henry Ford Hospital
- Study start
- 3 Dec 2014 (actual)
- Primary completion
- 31 Jul 2015 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 17 Apr 2017 (actual)
- Results
- Posted 20 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: Frequency of transcatheter and other structural heart procedures increased dramatically from 2012 to 2014 and is trending even higher for 2015. Procedures increased from 15 in 2012 to 50 cases in 2013 (233% increase) and to 70 cases in 2014 (40% increase from 2013 to 2014.) -- PT and OT identified a gap in consults and need for specific education targeted for a new surgery population (tAVR) without sternotomy. Often consults were placed on day of discharge to rehab facility or not at all. -- Structural Heart division of CV institute identified increased length of stay (LOS) and decreased activity of their patients in the hospital. -- No literature on this subject found via Henry Ford Hospital Sladen Library PubMed literature review
Aim: • Create a standardized pathway for new transcatheter aortic valve replacement patients in the Structural Heart Division (SHD)
- Improve patient outcomes including increasing the percentage of patients returning to home rather than a rehab facility destination at discharge
- Decrease length of stay
Implementation:
- Plan: PT and OT identified a gap in consults and need for specific education targeted at a new surgeries population (tAVR); Structural Heart division of CV institute identified an increase LOS and decreased activity of their patients in the hospital. In October 2014 planning began to introduce a SHD tAVR pathway that would include post procedure day number 0 nursing requirements and training, post procedure day number 1-3 PT and OT assessment and interventions.
- Do: Implemented pathway in November 2014.
- Check: Order set revision; Patient handouts ; Cardiac Rehab; Weekend criteria; staff training
- Act: February 2015, order sets in place, patient handouts finalized and full pathway finalized for post op tAVR patients.
- Continued checks identified additional SHD procedures and team determined that Mitral Clips and LARIATs were not criteria for tAVR pathway but would receive routine PT and OT consults.
Intervention: • Added PT and OT to Structural Heart Order Set.
- PT and OT assessments completed on post procedure day number day 1.
- PT and OT follow up treatments post procedure day number 2, 3 and beyond as appropriate.
- Patient education handouts individualized for patient population
- Pre-op education handouts individualized for patient population
Outcome measures: Hospital Length of stay, discharge disposition. Data Analysis: Chi-square tests are used to compare proportions between groups, while Wilcoxon two-sample tests are used to compare distributions of continuous variables between groups. This nonparametric test was chosen due to non-Gaussian distribution of the continuous outcomes within groups. Statistical significance was set at p<0.05. All analyses were performed using SAS 9.4 (SAS Institute Inc, Cary, North Carolina, USA).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 30 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post procedure routine PT and or OT | – | Other: Routine PT or OTRoutine PT and or OT |
| Post Procedure PT and OT pathway | – | Other: Post procedure daily PT and OT, Other: PT post procedure, Other: OT post procedurePost procedure day zero nursing mobilization; post procedure day one PT and OT assessment and intervention, daily PT and OT intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (2 listed)
- Occurrence of major events including stroke, pacemaker placement, other CV repair or surgery required, etc)
- procedure via appropriate other than femoral access (transapical, transcaval)
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 |
|---|---|---|
| Post procedure daily PT and OTPT evaluation and treatment on post procedure day zero: Nurses mobility patient using egress testing one time | Other | Post Procedure PT and OT pathway |
| PT post procedurepost procedure day one: PT and OT assessment, education and intervention. | Other | Post Procedure PT and OT pathway |
| OT post procedurePT and OT Daily until goals met or patient discharge. | Other | Post Procedure PT and OT pathway |
| Routine PT or OTRoutine PT or OT consulted by physician when identified discharge disposition of home | Other | Post procedure routine PT and or OT |
Primary outcome
Post Procedure Hospital Length of Stay
Time frame: at discharge
From date of procedure until date of hospital discharge, assessed up to 50 days.
Total Hospital Length of Stay
Time frame: at discharge
Days from Hospital admission to Hospital Discharge
2 secondary outcomes
Discharge Disposition, Home
Time frame: on day of hospital discharge
Discharge Destination, Rehab Facility
Time frame: on day of hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25086843Babaliaros 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.
- Background: PubMed 25413312Marcantuono 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.
- Background: PubMed 28304219Reardon 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.
- Individual participant dataSharing planned: No. IRB was closed March 08-2021 and no plans to share data from this preliminary study
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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.
Adele Myszenski, MPT principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transcatheter Aortic Valve Implantation, run by Henry Ford Health System 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 2 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 20 Jan 2023. 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?
Yes. Results are posted in the registry (first posted 20 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post Procedure Hospital Length of Stay (time frame: at discharge). The study lists 2 primary outcomes in all. 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 NCT03117296, which also lists 3 linked publications.
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 20 Jan 2023.