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Physical Therapy and Occupational Therapy After Transcatheter Aortic Valve Replacement
trial testing Post procedure daily PT and OT in Transcatheter Aortic Valve Implantation in 189 participants. Completed in 31 December 2017.
| Lead sponsor | Henry Ford Health System |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 189 |
| Start date | 3 December 2014 |
| Primary completion | 31 July 2015 |
| Estimated completion | 31 December 2017 |
| Sites | 1 location across United States |
Henry Ford Health System — full company profile →
Eligibility, any sex, with Transcatheter Aortic Valve Implantation. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
From date of procedure until date of hospital discharge, assessed up to 50 days.
| Group | Value | 95% CI |
|---|---|---|
| Control Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway Implementation | 4.8 | ± 2.9 |
| Intervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway Implementation | 3.5 | ± 4.0 |
Days from Hospital admission to Hospital Discharge
| Group | Value | 95% CI |
|---|---|---|
| Control Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway Implementation | 6.9 | ± 5.4 |
| Intervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway Implementation | 4.5 | ± 5.4 |
Discharge destination at discharge. Home includes those discharge home, Home with assistance or Home with Home care.
| Group | Value | 95% CI |
|---|---|---|
| Control Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway Implementation | 57 | |
| Intervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway Implementation | 99 |
At hospital discharge, did the patient return Home or were they discharged to a post-acute care Rehab Facility
| Group | Value | 95% CI |
|---|---|---|
| Control Group (TAVR 3/1/12-11/1/14) Pre PT OT Pathway Implementation | 17 | |
| Intervention Group (TAVR 11/2/14-12/31/15) Post PT OT Pathway Implementation | 16 |
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.
1 peer-reviewed publication reference this trial (live from Europe PMC):
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