An interventional study of Daily Activity Goal and Resistance Exercises in Aortic Valve Stenosis, sponsored by Vanderbilt University Medical Center. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-01.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment
Among 189 studies in Aortic Valve Stenosis with a site in United States — 44 open to participants now, 68 under way, 3 of them phase 3. Aortic Valve Stenosis · United States.
Among the 189 studies in Aortic Valve Stenosis with a site in United States, this one is the 76th largest by enrollment of the 125 interventional ones that give a count, is one of 8 that started in 2017, is one of 102 with no phase, and was the 96th registered.
1,025 studies on the registry are indexed under Aortic Valve Stenosis; 293 are open to participants now.
Browse Aortic Valve Stenosis studies →44 of the 189 studies in Aortic Valve Stenosis with a site in United States are open now. Recruiting first, the newest first:
American College of Cardiology · Sites in United States
EmStop Inc · Sites in United States
Dermed Diagnostics, Inc. · Sites in United States
Columbia University · Sites in United States
MiRus · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 209 Aortic Valve Stenosis studies recruiting now, 163 (78%) set no upper age limit and 9 (4%) stop at 75 or younger; 25 take children under 18; 14 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
189 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 7 · Phase 3 7 · Phase 4 6
First in 2000; this study’s year is marked. 8 started in 2017.
This study's enrollment of 85 is below the median of 126 across 554 interventional studies indexed under Aortic Valve Stenosis.
Median enrollment 172 across the 125 interventional studies, 102 across the 64 observational. Of the 106 that completed or were terminated, 50 (47%) have results posted.
This tab as a report to print or save as PDF → With an account.
82 of 189 have an industry lead sponsor. The 10 most frequent:
Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 155 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.
Vanderbilt University Medical Center has 2 studies filed under Aortic Valve Stenosis — fewer than ten, so there is no comparison to draw.
13 of the studies in Aortic Valve Stenosis with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06689839EnCompass Technologies, Inc.Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR | 2026-12 |
| NCT05603026University Hospitals Cleveland Medical CenterMRI in Transcatheter Aortic Valve Replacement Patients | 2026-12-30 |
| NCT07827105AccurKardia, Inc.ECG-based AI Screening for Cases of Undiagnosed Moderate-to-Severe Aortic Stenosis in the Primary Care Setting | 2027-02 |
| NCT06077201Vanderbilt University Medical CenterHome-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions | 2027-02-01 |
| NCT06580158Mayo ClinicAI in Outpatient Practice for Diagnosing Aortic Stenosis and Diastolic Dysfunction | 2027-03 |
Among the 189 studies in Aortic Valve Stenosis with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study is being performed in patients who have undergone transcatheter aortic valve replacement (TAVR) for aortic stenosis. The goal is to obtain pilot and feasibility data on a novel post-procedure rehabilitation strategy, including a daily activity goal using a fitness tracking device (Fitbit Alta HR) and in-home resistance training exercises targeting muscles related to activities of daily living. We will evaluate the effect of these interventions on physical performance and several quality of life domains.
The study will be conducted in three phases. Subjects who have been treated commercially with TAVR with a SAPIEN 3 valve and are being discharged to home will be eligible for Phase 1. Once consented prior to discharge, patients will complete the KCCQ, PROMIS Questionnaires, 5m walk, chair stand, and handgrip tests. During phase 1, all subjects will have a Fitbit and answer quality of life questions on the iPad about their activities and quality of life. After 30 days, the subject will return to complete the PROMIS Questionnaires, 5m walk, chair stand, balance tests, and handgrip tests, as well as a KCCQ. If the subject has consistently provided data throughout Phase 1, they will be asked to continue on to Phases 2 and 3 and complete a 6 minute walk test at this baseline visit. For Phase 2, subjects will be randomized to one of two arms. In one arm, they will have a daily activity goal and resistance exercises; in the other arm, there will not be a daily activity goal and no resistance exercises given. After 6 weeks, the subject will return to complete the 5m walk, 6 minute walk test, chair stand, balance tests, and handgrip tests, PROMIS Questionnaires, as well as a KCCQ. Five months after enrollment into Phase 2, subjects will be given a Fitbit to track their daily activity for 1 week (Phase 3). They will also complete a KCCQ, PROMIS Questionnaires, and end of study questionnaire.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Phase 1 - Starts after the TAVR procedure and prior to discharge • Patients treated commercially with TAVR with a SAPIEN 3 valve
Phases 2 and 3 - Starts at 30 day post-TAVR follow-up visit
Exclusion Criteria:
Phase 1 - Starts after the TAVR procedure and prior to discharge
Phases 2 and 3 - Starts at 30 day post-TAVR follow-up visit
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blinded use of Fitbit with no daily activity goal and no resistance exercises
Behavioral: Daily Activity Recording
Unblinded use of Fitbit with a daily activity goal (steps per day) and resistance exercises
Behavioral: Daily Activity Goal · Behavioral: Resistance Exercises · Behavioral: Daily Activity Recording
Patients are given a tailored daily activity goal in terms of steps per day for which to aim.
Also known as: Resistance Exercise and Activity Goal Arm
Patients will instructed to perform 3 different resistance exercises targeting muscles pertinent to activities of daily living on 6 out of 7 days a week.
Also known as: Resistance Exercise and Activity Goal Arm
A Fitbit will be worn by all participants to record daily activity.
Average Daily Steps
Average daily steps over the intervention period
Time frame: Randomization to 6 weeks
Short Physical Performance Battery score
Combination of gait speed, balance test, and chair-to-stand test at the end of the intervention
Time frame: 6 week value, adjusted for baseline value
Quality of Life as measured with the KCCQ Overall Summary Score
KCCQ overall summary score
Time frame: 6 week value, adjusted for baseline value
5 meter gait time at the end of the intervention period
5 meter gait time at the end of the intervention period, adjusted for baseline
Time frame: Randomization to 6 weeks
Chair Sit to Stand Test
Time to complete 5 chair stands
Time frame: 6 week value, adjusted for baseline value
Balance Test Score at the end of the intervention period
Balance Test Score at the end of the intervention period, adjusted for baseline
Time frame: Randomization to 6 weeks
6 minute walk
6 minute walk distance at the end of the intervention period
Time frame: 6 week value, adjusted for baseline value
Handgrip
Handgrip strength
Time frame: 6 week value, adjusted for baseline value
Average number of hours per day with 250 or more steps
Average number of hours per day with 250 or more steps over the intervention period
Time frame: Randomization to 6 weeks
Average Global Physical Health as assessed by the PROMIS Global Health 10 Short Form
Average Global Physical Health as assessed by the PROMIS Global Health 10 Short Form over the intervention period
Time frame: Randomization to 6 weeks
Average Global Mental Health as assessed by the PROMIS Global Health 10 Short Form
Average Global Mental Health as assessed by the PROMIS Global Health 10 Short Form over the intervention period
Time frame: Randomization to 6 weeks
Physical Function as assessed by the NIH PROMIS computerized adaptive test
Physical Function as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline
Time frame: Randomization to 6 weeks
Depression as assessed by the NIH PROMIS computerized adaptive test
Depression as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline
Time frame: Randomization to 6 weeks
Fatigue as assessed by the NIH PROMIS computerized adaptive test
Fatigue as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline
Time frame: Randomization to 6 weeks
Dyspnea as assessed by the NIH PROMIS computerized adaptive test
Dyspnea as assessed by the NIH PROMIS computerized adaptive test, adjusted for baseline
Time frame: Randomization to 6 weeks
Daily Active Minutes (total)
Average daily active minutes (total)
Time frame: Randomization to 6 weeks
Daily Active Minutes of Moderate to High Intensity
Average daily minutes of moderate to high intensity
Time frame: Randomization to 6 weeks
Sedentary Minutes
Average daily sedentary minutes
Time frame: Randomization to 6 weeks
Daily Steps
Average daily steps
Time frame: 6 weeks post baseline to end of study
Daily Active Minutes (total)
Average daily active minutes (total)
Time frame: 6 weeks post baseline to end of study
Daily Active Minutes of Moderate to High Intensity
Average daily active minutes of moderate to high intensity
Time frame: 6 weeks post baseline to end of study
Daily Sedentary Minutes
Average daily sedentary minutes
Time frame: 6 weeks post baseline to end of study
KCCQ Overall Summary Score
KCCQ overall summary score, adjusted for baseline
Time frame: 6 weeks post baseline to end of study
Global Physical Health
Global physical health as assessed by the PROMIS Global Health 10 Short Form, adjusted for baseline
Time frame: 6 weeks post baseline to end of study
Global Mental Health
Global mental health as assessed by the PROMIS Global Health 10 Short Form, adjusted for baseline
Time frame: 6 weeks post baseline to end of study
Plan to share: No
Ran from Nov 2017 to primary completion in Mar 2020, 28 months.
Of 177 non-industry interventional studies with no phase under Aortic Valve Stenosis, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 79. This study's 28 months is below that.
Counting every sponsor, half of 288 studies reached it within 33 months; a quarter within 18 and three quarters within 72.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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