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New treatment option for Atrial Fibrillation (AF)
Official title Discontinuation of Anticoagulations After Successful Catheter Ablation of Atrial Fibrillation
ClinicalTrials.gov ID: NCT06615596
What this study is testing
What is Anticoagulant drugs?
Anticoagulant drugs is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for atrial fibrillation (af).
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 DESTINATION Study investigates whether anticoagulation therapy is necessary after successful catheter ablation (CA) for atrial fibrillation (AF). Current guidelines recommend continued anticoagulation based on stroke risk scores, even post-ablation, potentially exposing patients to unnecessary bleeding risks.
- Phase 1: an early, usually small safety 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 18 and older
You may be able to join if
- Age ≥18 years
- Diagnosed paroxysmal, persistent, or longstanding persistent AF
- Successful procedure (defined as restoration of sinus rhythm after PV isolation for paroxysmal AF, restoration of sinus rhythm after PV isolation and...
- No periprocedural complications
- Signed informed consent
You likely can't join if
- Valvular AF (moderate- severe mitral insufficiency; relevant mitral stenosis with a mean pressure gradient \>5mmHg)
- Reversible AF (e.g. uncontrolled hyperthyroidism)
- Prior AF ablation (including surgical ablation)
- History of left atrial appendage occlusion/ligation/excision
- Concomitant surgical ablation
- Left atrial diameter \>50 mm
See the full eligibility criteria
- Age ≥18 years
- Diagnosed paroxysmal, persistent, or longstanding persistent AF
- Successful procedure (defined as restoration of sinus rhythm after PV isolation for paroxysmal AF, restoration of sinus rhythm after PV isolation and completion of additional ablation for persistent AF, according to...
- No periprocedural complications
- Signed informed consent
- Male with CHA2DS2-VASC score ≥1, female with score ≥2.
- Valvular AF (moderate- severe mitral insufficiency; relevant mitral stenosis with a mean pressure gradient \>5mmHg)
- Reversible AF (e.g. uncontrolled hyperthyroidism)
- Prior AF ablation (including surgical ablation)
- History of left atrial appendage occlusion/ligation/excision
- Concomitant surgical ablation
- Left atrial diameter \>50 mm
- Left atrial or LAA thrombus
- Pregnancy/breast feeding
- Women of childbearing age who refuse to use a highly effective and medically acceptable form of contraception throughout the study
- Patient has a non-arrhythmic condition necessitating long-term oral anticoagulation (i.e. PE, ventricular thrombus, peripheral thrombosis, etc)
- Recent myocardial infarction, NYHA class IV heart failure, patent foramen ovale, recent trauma or other prothrombotic conditions
- Patient with special risk factors for stroke unrelated to AF, specifically known thrombophilia/ hypercoagulability, uncontrolled hypertension (systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>100...
- Patient has bleeding contra-indication to oral anticoagulation (such as bleeding diathesis, hemorrhagic disorder, significant gastrointestinal bleeding within 6 months, intracranial/intraocular/ atraumatic bleeding...
- Patient has other contraindication to oral anticoagulation or treatment with antiplatelet agent
- Patient has been on strong CYP3A inducers (such as rifampicin, phenytoin, phenobarbital, or carbamazepine) or strong CYP3A inhibitors (such as ketoconazole or protease inhibitors) within 4 days of enrolment
- Structural congenital heart disease
- Recent stroke or intracranial hemorrhage within 6 months
- Inability to adequately understand nature, significance, implications and risks of study precipitation and to comply with follow-up (i.e. bipolar disorders, severe depression, suicidal tendencies, among others) as...
- Patients who are \> 85 years of age
- Patients who are critically ill or who have a life expectancy \<3 years
- Patient is unable or unwilling to provide informed consent
- Patient is included in another assigned by chance clinical trial or a clinical trial requiring an insurance
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- Beijing, Beijing Municipality, China
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
- Zhengzhou, Henan, China
- Wuhan, Hubei, China
- Shanghai, Shanghai Municipality, China
- Taiyuan, Shanxi, China
- Chengdu, Sichuan, China
- Kunming, Yunnan, China
- Hangzhou, Zhejiang, China
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 - 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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; Beijing, Beijing Municipality, China; Guangzhou, Guangdong, China; Shenzhen, Guangdong, China; Zhengzhou, Henan, China; Wuhan, Hubei, China and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.