Atrial Fibrillation study: AFSW Guided DOAC vs Continuous DOAC therapy
Official title The Rhythm Evaluation for AntiCoagulaTion With Continuous Monitoring of Atrial Fibrillation
ClinicalTrials.gov ID: NCT05836987
What this study is testing
What is Continuous DOAC therapy?
An investigational oral anticoagulant therapy being studied as a potential treatment for atrial fibrillation. DOACs are designed to inhibit specific clotting factors to reduce blood clot formation.
Also referred to as Oral Anticoagulation therapy.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if using a smartwatch that detects atrial fibrillation can safely guide a short‑term blood‑thinner treatment compared with the usual continuous treatment.
- Who it's for
- Adults who have paroxysmal or persistent atrial fibrillation and a low‑to‑moderate risk of stroke.
- What's involved
- Participants are randomly assigned to either keep taking a daily anticoagulant pill (standard care) or wear an AF‑sensing smartwatch and take the pill for one month when the watch signals irregular rhythm; they will have regular check‑ups and tests.
- Time commitment
- Participants will be followed for several months with periodic clinic visits and monitoring.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 85
You may be able to join if
- 22-85 years of age.
- English speaking participants. Spanish-only speakers may be included in the future at select sites appropriately translated.
- History of non-permanent atrial fibrillation.
- CHA2DS2-VASC score of 1-5 for men and 2-5 for women without prior stroke or Transient Ischemic Attack (TIA), The CHA2DS2-VASc score is a point-based...
- The participant is on a DOAC at the time of screening and willing to stay on DOAC for duration of study.
You likely can't join if
- Valvular or permanent atrial fibrillation.
- Current treatment with warfarin and unwilling or unable to take a DOAC.
- The participant is a woman who is pregnant or nursing.
- The participant is being treated with chronic daily oral NSAIDs and is unwilling or unable to discontinue use for the study duration.
- Existing cardiac rhythm device or indication for a permanent pacemaker, Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization...
- Known or suspected symptomatic or asymptomatic atrial fibrillation lasting ≥ 1 hour/month over the last 3 months.
See the full eligibility criteria
- 22-85 years of age.
- English speaking participants. Spanish-only speakers may be included in the future at select sites appropriately translated.
- History of non-permanent atrial fibrillation.
- CHA2DS2-VASC score of 1-5 for men and 2-5 for women without prior stroke or Transient Ischemic Attack (TIA), The CHA2DS2-VASc score is a point-based system used to stratify the risk of stroke in Atrial Fibrillation (AF)...
- The participant is on a DOAC at the time of screening and willing to stay on DOAC for duration of study.
- Possession of a smart watch-compatible smart phone (iPhone that supports the latest shipping iOS) with a cellular service plan
- Be willing to wear the smart watch for the suggested minimum of 14 hours a day
- Expected to be within cellular service range at least 80% of the time
- Willing and able to discontinue DOAC
- The participant is willing and able to provide informed consent.
- Valvular or permanent atrial fibrillation.
- Current treatment with warfarin and unwilling or unable to take a DOAC.
- The participant is a woman who is pregnant or nursing.
- The participant is being treated with chronic daily oral NSAIDs and is unwilling or unable to discontinue use for the study duration. Use of low-dose aspirin is permitted.
- Existing cardiac rhythm device or indication for a permanent pacemaker, Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT) device or planned insertable cardiac monitor.
- Known or suspected symptomatic or asymptomatic atrial fibrillation lasting ≥ 1 hour/month over the last 3 months.
- Any documented single AF episode lasting ≥ 1 hour on a cardiac monitor performed within 90 days prior to randomization.
- Ablation for AF within the last 2 months.
- Prior or anticipated left atrial appendage occlusion or ligation.
- Mechanical prosthetic valve(s) or severe valve disease.
- Hypertrophic cardiomyopathy.
- Participant needs DOAC for reasons other than preventing stroke or arterial embolism resulting from AF (i.e., preventing Deep Vein Thrombosis (DVT) or PE) or needs permanent OAC (i.e., congenital heart defects...
- Participants deemed high risk for non-cardioembolic stroke (i.e., significant carotid artery disease defined as stenosis \> 75%) based on the investigator's discretion.
- The participant is enrolled, has participated within the last 30 days, or is planning to participate in a concurrent drug and/or device study during the course of this clinical trial.
- The participant has a tattoo, birthmark, or surgical scar over the dorsal wrist area on the ipsilateral side that the AFSW may be worn.
- The participant has a tremor on their ipsilateral side that the AFSW may be worn.
- Any concomitant condition that, in the investigator's opinion, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).
- Known hypersensitivity or contraindication to direct oral anticoagulants.
- Documented prior stroke (ischemic or hemorrhagic) or transient ischemic attack.
- Reversible causes of AF (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism). AF ablation does not constitute reversible AF.
- \> 5% burden of premature atrial or ventricular depolarizations on pre-enrollment cardiac monitoring.
- History of ECG-documented, sustained atrial flutter that has not been treated with ablation (participants with atrial flutter who have been ablated are eligible for enrollment)
- Stage 4 or 5 chronic kidney disease.
- Major surgery in the previous month
- Planned surgery or intervention in the next three months that would require cessation of anticoagulation \> 2 weeks.
- History of intracranial, intraocular, spinal, retroperitoneal, or atraumatic intra- articular bleeding
- Gastrointestinal hemorrhage within the past year unless the cause has been permanently eliminated (e.g., by surgery)
- Symptomatic or endoscopically documented gastroduodenal ulcer disease in the previous 30 days
- Hemorrhagic disorder or bleeding diathesis
- Need for anticoagulant treatment for disorders other than AF
- Uncontrolled hypertension (Systolic Blood Pressure \>180 mmHg and/or Diastolic Blood Pressure \>100 mmHg)
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- Stanford, California, United States
- Aurora, Colorado, United States
- Littleton, Colorado, United States
- Clearwater, Florida, United States
- Gainesville, Florida, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Winter Haven, Florida, United States
- Atlanta, Georgia, United States
- Warner Robins, Georgia, United States
- Chicago, Illinois, United States
- Elk Grove Village, Illinois, United States
- Evanston, Illinois, United States
- Naperville, Illinois, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
+ 43 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Los Angeles, California, United States; Sacramento, California, United States; San Diego, California, United States; Stanford, California, United States; Aurora, Colorado, United States and 57 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.