Transcatheter Aortic Valve Replacement (TAVR)TAVR-PTNCT02723422
Transcatheter Aortic Valve Replacement (TAVR)-Pilot Trial
A study testing Prehabilitation visit/increased physical therapy post-TAVR in people with Transcatheter Aortic Valve Replacement (TAVR), run by NYU Langone Health.
Trial summary
The primary purpose of this this randomized interventional study is to determine if increased level of home-based rehabilitation coupled with a pre-TAVR consultation visit in transcatheter aortic valve replacement patients will improve functional status and quality of life and will decrease hospital readmission. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Transcatheter Aortic Valve Replacement (TAVR)
- What is being tested?
- Prehabilitation visit/increased physical therapy post-TAVR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2017
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Diagnosis of severe aortic stenosis (AS) as determined by echocardiography, who are deemed eligible for TAVR by the NYULMC Heart Valve Team
Who cannot join
- Decisional impairment as assessed by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)
- Non-English/non-Spanish speaking.
About this study
Official title: Intensive Versus Usual Home-based Physical Therapy to Promote Functional Recovery After Transcatheter Aortic Valve Replacement (TAVR): A Pilot Randomized Trial
The primary purpose of this this randomized interventional study is to determine if increased level of home-based rehabilitation coupled with a pre-TAVR consultation visit in transcatheter aortic valve replacement patients will improve functional status and quality of life and will decrease hospital readmission.
- Being tested
- Prehabilitation visit/increased physical therapy post-TAVR, Standard of Care Arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prehabilitation visit/increased physical therapy post-TAVRProcedure or surgery
Prior to TAVR, patients randomized to the intervention arm will meet with a licensed physical therapist for a 30-minute session in the ambulatory setting. Following TAVR, patients randomized to the intervention arm will receive 4 days per week of home-based physical therapy by a licensed physical therapist working for Revival Home Health Care
Standard of Care ArmProcedure or surgery
Patients randomized to the usual care arm will receive home-based physical therapy for 2 days per week by Revival Home Health Care, which is the current standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation Visit/Increased Physical Therapy post-TAVR | Experimental | Not described Receives: Procedure: Prehabilitation visit/increased physical therapy post-TAVR |
| Control | Active comparator | Standard of care physical therapy post-TAVR Receives: Procedure: Standard of Care Arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in level of Activity measured by activity monitor called the ActiGraph wGT3X-BT.
Measured: Baseline, 2 Weeks
Change in self-perceived physical health
Measured: Baseline, 2 Weeks
Change in Independence in activities of daily living (ADLs).
Measured: Baseline, 2 Weeks
Secondary outcomes (1)
Reduction in hospital readmissions following intensive home-based physical therapy reduces
Measured: Baseline, 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcatheter Aortic Valve Replacement (TAVR)Studies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Dodson, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723422
- Sponsor's protocol ID
- 15-01098
- Acronym
- TAVR-PT
- Status last verified
- Jan 2017
- First submitted
- 9 Mar 2016
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Versus Usual Home-based Physical Therapy to Promote Functional Recovery After Transcatheter Aortic Valve Replacement (TAVR): A Pilot Randomized Trial
- ClinicalTrials.gov ID
- NCT02723422
- Acronym / sponsor ID
- TAVR-PT / 15-01098
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 30 Mar 2016 (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 primary purpose of this this randomized interventional study is to determine if increased level of home-based rehabilitation coupled with a pre-TAVR consultation visit in transcatheter aortic valve replacement patients will improve functional status and quality of life and will decrease hospital readmission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation Visit/Increased Physical Therapy post-TAVR | Experimental | Procedure: Prehabilitation visit/increased physical therapy post-TAVR |
| Control | Active comparator | Procedure: Standard of Care ArmStandard of care physical therapy post-TAVR |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Diagnosis of severe aortic stenosis (AS) as determined by echocardiography, who are deemed eligible for TAVR by the NYULMC Heart Valve Team
Key exclusion criteria (2 listed)
- Decisional impairment as assessed by the University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)
- Non-English/non-Spanish speaking.
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 |
|---|---|---|
| Prehabilitation visit/increased physical therapy post-TAVRPrior to TAVR, patients randomized to the intervention arm will meet with a licensed physical therapist for a 30-minute session in the ambulatory setting. Following TAVR, patients randomized to the intervention arm will receive 4 days per week of home-based physical therapy by a licensed physical therapist working for Revival Home Health Care | Procedure or surgery | Prehabilitation Visit/Increased Physical Therapy post-TAVR |
| Standard of Care ArmPatients randomized to the usual care arm will receive home-based physical therapy for 2 days per week by Revival Home Health Care, which is the current standard of care. | Procedure or surgery | Control |
Primary outcome
Change in level of Activity measured by activity monitor called the ActiGraph wGT3X-BT.
Time frame: Baseline, 2 Weeks
Change in self-perceived physical health
Time frame: Baseline, 2 Weeks
Change in Independence in activities of daily living (ADLs).
Time frame: Baseline, 2 Weeks
1 secondary outcome
Reduction in hospital readmissions following intensive home-based physical therapy reduces
Time frame: Baseline, 2 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
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REVIVE-FR Registry
Bioprosthetic Valve Failure, Prosthetic Heart Valve Dysfunction
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Down Sizing Strategy (HANGZHOU Solution) vs Standard Sizing Strategy TAVR in Bicuspid Aortic Stenosis (Type 0)
Aortic Stenosis With Bicuspid Valve
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Impact of Beta Blockers on TAVI (BETA-TAVI)
Aortic Valve Stenosis
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.
John Dodson, MD principal investigator
New York University Medical School
Questions about this trial
What is this clinical trial studying?
A study testing Prehabilitation visit/increased physical therapy post-TAVR in people with Transcatheter Aortic Valve Replacement (TAVR), run by NYU Langone Health.
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 1 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: withdrawn, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in level of Activity measured by activity monitor called the ActiGraph wGT3X-BT. (time frame: Baseline, 2 Weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2017.