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NCT06938412 · ClinicalTrials.gov registry record · NA
Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation
A NA study of Cardiovascular Diseases and Atrial Fibrillation, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- NA
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT06938412: Recruiting NA study of Cardiovascular Diseases and Atrial Fibrillation, sponsored by Icahn School of Medicine at Mount Sinai.
NCT06938412 is a NA study of Cardiovascular Diseases and Atrial Fibrillation that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 120 participants, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06938412, a NA study of Cardiovascular Diseases and Atrial Fibrillation, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study Summary
Atrial fibrillation (AF) affects 1 in 4 individuals during their lifetime and continues to increase in frequency and impact. Exercise intervention has established benefits to improve AF symptoms and burden in clinical studies. However, lack of access to exercise programs has limited therapeutic adoption. The growth of technology-driven health care and diagnostics, recognized as an emerging priority by the American Heart Association, offers an opportunity for a pragmatic and patient-centered approach to meet this need. EASE-AF is a prospective, interventional study with a sequential run-in control to evaluate if a digital health-driven, patient-centered exercise intervention improves AF symptoms and burden. The research team will enroll 120 patients with symptomatic, paroxysmal AF. The main impact of this study will be the establishment of evidence for a novel, pragmatic paradigm for a patient-centered, digital technology-driven personalized exercise intervention for patients with AF.
Primary Outcome
The Symptom Severity domain (Part C) of the validated Atrial Fibrillation Severity Scale (AFSS) questions patients regarding the severity of 7 AF-related symptoms (on scale of 0-5 per question, 5 denoting a great deal of symptom and 0 with no symptom) over the preceding 4-week period. Total scores range 0-35 on the Symptom Severity Domain of the Atrial Fibrillation Severity Scale (AFSS), higher score denotes more severe AF-related symptoms.
Conditions Studied
Interventions
- DEVICE Physical Activity Intervention Using FitBit Wearable Device
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-10 |
| Est. Completion | 2027-03-31 |
| Phase | NA |
What NCT06938412 shows while recruiting
NCT06938412 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 26,974-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (100% lower).
The record links to 3 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 1 intervention - of which Physical Activity Intervention Using FitBit Wearable Device is the first listed.
NCT06938412 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06938412 about?
NCT06938412 is a clinical study titled "Exercise Activity Intervention With Sensor-Based Engagement in Patients With Atrial Fibrillation". Atrial fibrillation (AF) affects 1 in 4 individuals during their lifetime and continues to increase in frequency and impact. Exercise intervention has established benefits to improve AF symptoms and burden in clinical studies. However, lack of access to exercise programs has limited therapeutic adop...
What is the current status of trial NCT06938412?
This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2025-10. Estimated completion is 2027-03-31.
What conditions does trial NCT06938412 study?
This clinical trial studies the following conditions: Cardiovascular Diseases, Atrial Fibrillation, Arrhythmias, Cardiac.
What interventions are being tested in trial NCT06938412?
The interventions under investigation include: Physical Activity Intervention Using FitBit Wearable Device (DEVICE).
Who is sponsoring clinical trial NCT06938412?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06938412 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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.
Where NCT06938412's enrollment target sits among peer trials
120 181st of 300 higher than 116 of 300 other Cardiovascular Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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