AzTrials
AzTrials

Atrial Fibrillation (AF)Early Phase 1DESTINATIONNCT06615596

Discontinuation of Anticoagulations After Successful Catheter Ablation of Atrial Fibrillation

A Early Phase 1 study testing discontinue anticoagulation therapy, Anticoagulant drugs and Catheter Ablation in people with Atrial Fibrillation (AF), run by China National Center for Cardiovascular Diseases at 12 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Atrial Fibrillation (AF)
What is being tested?
discontinue anticoagulation therapy, Anticoagulant drugs and Catheter Ablation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,160 participants
Where
12 sitesin 2 countries
Study dates
5 Aug 2025to 31 Dec 2029
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation) and no recurrence within 3 months of ablation, using a cooled tip RF-, laser- or cryo-balloon-catheter
  • No periprocedural complications
  • Signed informed consent
  • Male with CHA2DS2-VASC score ≥1, female with score ≥2.

Who cannot join

  • 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
Show all 22Show fewer
  • 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 mmHg within 4 days of enrollment), untreated familial hyperlipidemia, known vascular anomaly (intracranial aneurysm/ arteriovenous malformation or chronic vascular dissection), or known severe carotid disease.
  • Patient has bleeding contra-indication to oral anticoagulation (such as bleeding diathesis, hemorrhagic disorder, significant gastrointestinal bleeding within 6 months, intracranial/intraocular/ atraumatic bleeding history, fibrinolysis within 48 hours of enrollment).
  • 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 judged by the local physician, ongoing drug or alcohol addiction (\> 8 drinks/week)
  • 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 randomized clinical trial or a clinical trial requiring an insurance

Trial locations and contacts

12 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Yan Yao, PhD contact

13901121319

ianyao@263.net.cn

Lingmin Wu, Phd contact

wulingmin@fuwai.com

12 sites in 2 countries

China11 sites, 11 recruiting
  • Beijing Anzhen Hospital

    Beijing, Beijing Municipality, 100011

    Yunlong Wang, PhD, 13937193530, Yunlong76818@126.com

    Not yet recruiting
  • Fuwai Hospital

    Beijing, Beijing Municipality, 100037

    Ligang Ding, Phd, 18610561552, dlgang101@163.com

    Ligang Ding, dlgang101@163.com

    Recruiting
  • West China Hospital, Sichuan University

    Chengdu, Sichuan

    Hua Fu, PhD, 13908042335, fuhua0108@qq.com

    Not yet recruiting
  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

    Jiangui He, PhD, 18902233622, hejiangui@163.com

    Not yet recruiting
  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Chenyang Cheng, PhD, 13857190051, jiangchenyang@hotmail.com

    Recruiting
  • Yunnan Fuwai Cardiovascular Hospital

    Kunming, Yunnan

    Jinrui Guo, Phd, 17801013903, Sailor2k@163.com

    Not yet recruiting
  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality

    Xu Liu, PhD, 15026921131, xkliuxu@126.com

    Not yet recruiting
  • Fuwai Hospital Chinese Academy of Medical Sciences, Shenzhen

    Shenzhen, Guangdong

    Yan Yao, Phd, 13901121319, ianyao@263.net.cn

    Zhongpeng Du, Phd, 18819045381

    Recruiting
  • Shanxi Cardiovascular Hospital (Shanxi Cardiovascular Research Institute)

    Taiyuan, Shanxi

    Haixiong Wang, PhD, 15003433600, cz1976whx@126.com

    Not yet recruiting
  • Wuhan Asia Heart Hospital

    Wuhan, Hubei

    Jinlin Zhang, PhD, 15972226949, zjl1974@yeah.net

    Recruiting
  • Fuwai Central China Cardiovascular Hospital

    Zhengzhou, Henan

    Xianqing Wang, PhD, 13937193530, 13937193530@139.com

    Not yet recruiting

Other trials in China

United States1 site, 1 recruiting
  • Brigham and Women Hospital

    Boston, Massachusetts, 02115

    Paul Zei, PhD, +1 (650) 521-2173, pzei@bwh.harvard.edu

    Paul Zei, PhD

    Not yet recruiting

Other trials in United States

About this study

Official title: Discontinuation of Anticoagulations After Successful Catheter Ablation of Atrial Fibrillation: DESTINATION Study

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. This international, multicenter, randomized controlled trial aims to compare thromboembolic and bleeding event risks between patients who continue and discontinue anticoagulation after ablation. The study involves 3,160 AF patients, all free of AF recurrence within 6 months to 1 year after ablation. Smart wearable monitors will track recurrence, and patients are followed for 24 months to assess event rates. Findings may reshape anticoagulation guidelines, improving clinical practice for AF patients worldwide.

Read the detailed description

This prospective, international, multicenter randomized controlled trial (RCT) investigates the safety and necessity of continuing anticoagulation therapy after successful catheter ablation of atrial fibrillation. The study will enroll 3,160 patients who underwent catheter ablation for AF and achieved no recurrence within 6 months to 1 year post-procedure. Participants will be randomly assigned to either continue or discontinue anticoagulation therapy. Smart wearable devices will monitor AF recurrence every 3 months, detecting both symptomatic and asymptomatic events. The study\'s primary endpoint is a composite of ischemic stroke, systemic embolism, and major bleeding at a 24-month follow-up. Secondary outcomes include AF recurrence rates, re-ablation needs, and quality of life measures. Participants are monitored through follow-up visits at 3, 6, 12, 18, and 24 months, and data from wearable devices will be transmitted to the research team. This study is significant due to the diversity of the population, with sites in China and the US, allowing for results that are generalizable across ethnic and geographic lines. The trial\'s findings aim to provide high-quality evidence to inform future guideline recommendations regarding post-ablation anticoagulation therapy, potentially reducing unnecessary bleeding risks and optimizing treatment outcomes. The inclusion of smart wearable monitors enhances the detection of asymptomatic recurrences and provides continuous, reliable data on patient health during the follow-up period.

Being tested
discontinue anticoagulation therapy, Anticoagulant drugs, Catheter Ablation
Keywords
Atrial Fibrillation, Catheter Ablation, Anticoagulation Discontinuation, Post-Ablation Monitoring, Randomized Controlled Trial, Thromboembolic Risk, Smart Wearable Devices, AF Recurrence Detection
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • discontinue anticoagulation therapyBehavioural

    Participants in the discontinuation arm will cease anticoagulation therapy following randomization. Smart wearable devices will monitor for AF recurrence, and patients will be followed for 24 months, with primary endpoints including thromboembolic and bleeding events.

  • Anticoagulant drugsDrug

    Participants in the continuation arm will receive oral anticoagulant drugs such as dabigatran, rivaroxaban, apixaban, warfarin, etc. tailored to their specific risk profiles. The discontinuation arm will cease anticoagulation therapy following randomization. Smart wearable devices will monitor for AF recurrence, and patients will be followed for 24 months, with primary endpoints including thromboembolic and bleeding events.

  • Catheter AblationProcedure or surgery

    Catheter ablation is a medical procedure used to treat atrial fibrillation (AF) by targeting and destroying small areas of heart tissue that cause irregular heartbeats. Using a specialized catheter, radiofrequency energy, cryotherapy, or pulsed field ablation (PFA) is applied to isolate the pulmonary veins or ablate other specific heart areas. The goal is to restore normal heart rhythm by electrically isolating problematic areas responsible for AF. This FDA-regulated procedure is minimally invasive and requires follow-up monitoring for AF recurrence and other potential complications. No specific ablation technique is mandated, allowing flexibility for operators to choose based on their expertise and center practices. The ablation strategy may include pulmonary vein isolation or additional procedures based on the type of AF. This approach distinguishes the study by providing real-world applicability, reflecting the diversity of ablation methods used in clinical practice.

Study groups in NCT06615596
Study groupRoleWhat they receive
on-OACActive comparatorIn the cohort assigned to the "on-OAC" arm, which entails the continuation of Oral Anticoagulant (OAC) therapy, patients were prescribed Non-Vitamin K Antagonist Oral Anticoagulants (NOACs), specifically dabigatran, rivaroxaban, or apixaban, for a duration of 24 months following randomization. The dosing regimen was as follows: (1) Standard dosage included rivaroxaban at 20mg daily, apixaban at 5mg twice daily, and dabigatran at 150mg twice daily. (2) Reduced dosage was administered in cases where patients were aged over 75 years, had a body weight less than 50kg, or exhibited creatinine clearance below 50ml/min.
Receives: Drug: Anticoagulant drugs; Procedure: Catheter Ablation
off-OACExperimentalIn the off-OAC, involving the discontinuation of OAC therapy, patients had their OAC treatment terminated post-randomization, and no placebo medication was administered as a substitute.
Receives: Behavioral: discontinue anticoagulation therapy; Procedure: Catheter Ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Composite outcome consisting of thromboembolic events and clinically significant bleeding events

    The primary endpoint of this study comprises a composite outcome consisting of thromboembolic events and clinically significant bleeding events. Specifically, it encompasses the following components:

    1. Incidence of ischemic stroke and systemic thromboembolism within the 2-year post-ablation period in each respective study group.
    2. Incidence of clinically significant bleeding within the 2-year post-ablation period in each respective study group.

    Unit of Measure: Number of events (strokes, systemic embolism, major bleeding episodes).

    Measured: 24 month

Secondary outcomes (6)
  1. AF Recurrence Rate

    Percentage of patients with documented AF recurrence at 2 years.

    Measured: 24 month

  2. Repeat Ablation Proportion

    Percentage of patients undergoing repeat ablation within each group

    Measured: 24 month

  3. Thromboembolic/Bleeding Event Rates after repeat procedure

    Percentage of patients with Thromboembolic and Bleeding events after repeat ablation in each group

    Measured: 24 month

  4. Thromboembolic/Bleeding Event Rates after recurrence in off-OAC

    Percentage of patients with thromboembolic and bleeding event rates in patients resuming anticoagulation therapy due to AF recurrence in the no anticoagulation group

    Measured: 24 month

  5. Major Adverse Cardiovascular Events (MACE)

    Number of MACE events including acute coronary syndrome, acute myocardial infarction (MI), serious arrhythmias, heart failure, cardiovascular mortality, and all-cause mortality in each group

    Measured: 24 month

  6. Complication rates

    Incidence rates of complications include bleeding, cardiac tamponade, vascular damage, pulmonary vein stenosis, stroke or thromboembolism, heart block, esophageal injury, infection, etc. based on different ablation method

    Measured: 24 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2024
  2. Study start5 Aug 2025
  3. Primary completion1 Jan 2029 (estimated)
  4. Study completion31 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
The intervention in this study involves two arms: patients either continue or discontinue anticoagulation therapy after successful catheter ablation for atrial fibrillation (AF). Participants in the continuation arm will receive non-vitamin K antagonist oral anticoagulants (NOACs) such as dabigatran, rivaroxaban, apixaban, etc or warfarin tailored to their specific risk profiles. The discontinuation arm will cease anticoagulation therapy following randomization. Smart wearable devices will monitor for AF recurrence, and patients will be followed for 24 months, with primary endpoints including thromboembolic and bleeding events.
Masking
None (open label)
Enrolment
3,160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06615596
Sponsor's protocol ID
NCRCSZ-2023-011
Acronym
DESTINATION
Status last verified
Jun 2026
First submitted
22 Sep 2024
Last updated
4 Jun 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing discontinue anticoagulation therapy, Anticoagulant drugs and Catheter Ablation in people with Atrial Fibrillation (AF), run by China National Center for Cardiovascular Diseases at 12 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in China, United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yan Yao, PhD (13901121319, ianyao@263.net.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Composite outcome consisting of thromboembolic events and clinically significant bleeding events (time frame: 24 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in