Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT06077201 · ClinicalTrials.gov registry record · NA

Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions

A NA study of Valvular Heart Disease, sponsored by Vanderbilt University Medical Center.

Recruiting
Registry status
NA
Development phase
375
Enrollment target
1
Study location

NCT06077201 is a NA study of Valvular Heart Disease that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 375 participants, below the 1,135-participant average among 8 other Valvular Heart Disease trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT06077201, a NA study of Valvular Heart Disease, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.

RECRUITING
Registry status
NA
Development phase
375 participants
Enrollment target
1
Study location

Study Summary

The vast majority of cardiac rehabilitation eligible individuals do not participate in center based cardiac rehabilitation (CBCR). While steps to encourage participation in CBCR are important, many individuals will still not participate for a variety of reasons. This randomized controlled trial is evaluating a home-based cardiac rehabilitation (HBCR) intervention delivered using a custom app and digital tools in patients undergoing transcatheter heart valve interventions (THVIs). After a brief roll-in period, participants not intending to participate in CBCR are randomized to one of three groups: (1) control, (2) HBCR mobile health intervention with hands-off delivery, and (3) HBCR mobile health intervention with interactive delivery. Participants in the intervention groups (hands-off/interactive delivery) will also be randomized to continue the intervention for 12 weeks or 24 weeks. The intervention targets key health behaviors and includes traditional cardiac rehabilitation components. The study will assess the effect of the intervention on clinical events, physical activity, quality of life, and other outcomes. Those who intend to participate in CBCR will be followed in a registry.

Conditions Studied

Valvular Heart Disease

Interventions

  • OTHER HBCR hands-off
  • OTHER HBCR interactive

Study Locations (1)

Tennessee

  • Vanderbilt University Medical Center - Nashville

Trial Details

FieldValue
Enrollment Target 375 participants
Start Date 2023-12-15
Est. Completion 2026-10-01
Phase NA

Sponsor

Vanderbilt University Medical Center

677 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06077201

The ClinicalTrials.gov registry entry for NCT06077201 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 375 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,135-participant average among 8 other Valvular Heart Disease trials with a reported enrollment target (67% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Valvular Heart Disease appearing as the primary indexed condition, and to 2 interventions - of which HBCR hands-off is the first listed.

NCT06077201 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.

Frequently Asked Questions

What is clinical trial NCT06077201 about?

NCT06077201 is a clinical study titled "Home-Based Cardiac Rehabilitation Using a Novel Mobile Health Exercise Regimen Following Transcatheter Heart Valve Interventions". The vast majority of cardiac rehabilitation eligible individuals do not participate in center based cardiac rehabilitation (CBCR). While steps to encourage participation in CBCR are important, many individuals will still not participate for a variety of reasons. This randomized controlled trial is e...

What is the current status of trial NCT06077201?

This trial is currently recruiting. It is a NA study. The enrollment target is 375 participants. The study started on 2023-12-15. Estimated completion is 2026-10-01.

What conditions does trial NCT06077201 study?

This clinical trial studies the following conditions: Valvular Heart Disease.

What interventions are being tested in trial NCT06077201?

The interventions under investigation include: HBCR hands-off (OTHER), HBCR interactive (OTHER).

Who is sponsoring clinical trial NCT06077201?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06077201 being conducted?

This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Valvular Heart Disease

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Valvular Heart Disease

All registered trials for this condition

Tennessee

All trials with a study site in Tennessee

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.