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Published on: February 26, 2013
Pandemic-proof recruitment and engagement in a fully decentralized trial in atrial fibrillation patients (DeTAP)
Ashish Sarraju1,2, Clark Seninger2, Vijaya Parameswaran1
1Division of Cardiovascular Medicine & Cardiovascular Institute, Stanford University School of Medicine, Palo Alto, California, USA.
Abstract:
The Coronavirus Disease 2019 (COVID-19) pandemic curtailed clinical trial activity. Decentralized clinical trials (DCTs) can expand trial access and reduce exposure risk but their feasibility remains uncertain. We evaluated DCT feasibility for atrial fibrillation (AF) patients on oral anticoagulation (OAC). DeTAP (Decentralized Trial in Afib Patients, NCT04471623) was a 6-month, single-arm, 100% virtual study of 100 AF patients on OAC aged >55 years, recruited traditionally and through social media. Participants enrolled and participated virtually using a mobile application and remote blood pressure (BP) and six-lead electrocardiogram (ECG) sensors. Four engagement-based primary endpoints included changes in pre- versus end-of-study OAC adherence (OACA), and % completion of televisits, surveys, and ECG and BP measurements. Secondary endpoints included survey-based nuisance bleeding and patient feedback. 100 subjects (mean age 70 years, 44% women, 90% White) were recruited in 28 days (traditional: 6 pts; social media: 94 pts in 12 days with >300 waitlisted). Study engagement was high: 91% televisits, 85% surveys, and 99% ECG and 99% BP measurement completion. OACA was unchanged at 6 months (baseline: 97 ± 9%, 6 months: 96 ± 15%, p = 0.39). In patients with low baseline OACA (<90%), there was significant 6-month improvement (85 ± 16% to 96 ± 6%, p < 0.01). 86% of respondents (69/80) expressed willingness to continue in a longer trial. The DeTAP study demonstrated rapid recruitment, high engagement, and physiologic reporting via the integration of digital technologies and dedicated study coordination. These findings may inform DCT designs for future cardiovascular trials.
Insights
Decentralized clinical trials (DCTs) show feasibility in atrial fibrillation patients on oral anticoagulation (OAC). The DeTAP study demonstrated rapid recruitment and high patient engagement, supporting DCTs for cardiovascular research.
Area of Science:
- Cardiology
- Clinical Trial Design
- Digital Health
Background:
- The COVID-19 pandemic disrupted traditional clinical trials.
- Decentralized clinical trials (DCTs) offer potential solutions for access and safety.
- Feasibility of DCTs for specific patient populations, like those with atrial fibrillation (AF) on oral anticoagulation (OAC), requires evaluation.
Purpose of the Study:
- To assess the feasibility of a 100% virtual decentralized clinical trial (DCT) for patients with atrial fibrillation (AF) on oral anticoagulation (OAC).
- To evaluate rapid recruitment strategies and high patient engagement in a DCT setting.
- To examine oral anticoagulation adherence (OACA) and physiologic data collection via remote sensors.
Main Methods:
- The DeTAP study (NCT04471623) was a 6-month, single-arm, virtual trial involving 100 AF patients (>55 years) on OAC.
- Participants were recruited via traditional methods and social media, enrolling and engaging through a mobile app and remote monitoring devices (BP, ECG).
- Primary endpoints focused on engagement metrics: OAC adherence (OACA), televisits, surveys, and remote measurements; secondary endpoints included bleeding and patient feedback.
Main Results:
- Recruitment was rapid, with 100 patients enrolled in 28 days, primarily through social media (94 patients in 12 days).
- High study engagement was observed: 91% televisit completion, 85% survey completion, 99% ECG, and 99% BP measurement completion.
- Oral anticoagulation adherence (OACA) remained stable overall (97% to 96%), but significantly improved in patients with low baseline adherence (<90%).
Conclusions:
- The DeTAP study successfully demonstrated the feasibility of a fully virtual DCT for AF patients on OAC.
- Integration of digital technologies and remote monitoring facilitated rapid recruitment and sustained high patient engagement.
- Findings support the use of DCT models for future cardiovascular clinical trials, enhancing accessibility and efficiency.
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