Discontinuation of Anticoagulation With Intensive Rhythm Monitoring in Post-ablation Patients With Atrial Fibrillation

NCT06871228 | Recruiting DMC

• 1 other identifier: 2025KLS09
• Study Type: interventional
• Target: 4,100
• Locations: 1 country
• Sites: 22

Brief Summary

DIAMOND-AF is a multicenter, randomized, open-label trial evaluating whether discontinuing oral anticoagulation after successful atrial fibrillation ablation can reduce bleeding risk without increasing death or thromboembolism risks. Adults aged 18-80 years, 60-365 days post-ablation, with CHA2DS2-VA ≥2, no prior stroke/TIA/systemic embolism, continuous NOAC use, and no documented atrial tachyarrhythmia recurrence will be randomized 1:1 to stop NOACs immediately or to continue NOAC therapy. All participants use intensified rhythm surveillance including smartwatch ECG and Holter/patch monitoring (at least every 6 months; every 2 months encouraged) to detect recurrence. Co-primary endpoints are (1) non-inferiority for the composite of all-cause death, ischemic stroke, or systemic embolism and (2) superiority for the composite of ISTH major bleeding or ISTH clinically relevant non-major bleeding. The planned sample size is 4,100 participants.

Conditions

Atrial Fibrillation (AF)

Keywords

atrial fibrillation; catheter ablation; smartwatch; anticoagulation; thromboembolism; bleeding

Outcome Measures

Primary Outcomes (2)

• A composite of all-cause death, ischemic stroke, or systemic embolism

  The primary effectiveness outcome is to determine whether NOAC discontinuation with intensified rhythm monitoring is non-inferior to continued NOAC therapy for the composite of all-cause death, ischemic stroke, or systematic embolism. Ischemic stroke is defined as an acute focal dysfunction from CNS infarction lasting ≥24h, with potential hemorrhagic transformation. Systemic embolism refers to arterial embolism or thrombosis (excluding stroke or TIA).

  48 months

• ISTH major bleeding or ISTH clinically relevant non-major bleeding

  The primary safety outcome is to determine whether NOAC discontinuation is superior to continued NOAC therapy in reducing the composite of ISTH major bleeding or ISTH clinically relevant non-major bleeding (CRNMB). ISTH major bleeding and CRNMB are defined per ISTH criteria (e.g., fatal bleeding; critical-site bleeding; hemoglobin drop ≥20 g/L or transfusion ≥2 units for major bleeding; and medically attended, hospitalization-escalating, or unplanned-visit bleeding for CRNMB).

  48 months

Secondary Outcomes (11)

• All-cause death

  48 months

• Ischemic stroke

  48 months

• Systemic embolism

  48 months

• Major bleeding

  48 months

• Clinically relevant non-major bleeding

  48 months

Study Arms (2)

Discontinuation of NOACs

EXPERIMENTAL

Participants randomized to the experimental arm will stop oral anticoagulation (NOACs) immediately after randomization. All participants in this trial (including this arm) will undergo intensified rhythm surveillance using a smartwatch capable of single-lead ECG plus scheduled Holter or single-lead ECG patch monitoring (at least every 6 months; every 2 months encouraged), with symptom-triggered and opportunistic ECGs. AF recurrence is defined as ECG-documented AF/AFL/atrial tachycardia lasting ≥30 seconds.

Drug: NOAC discontinuation; Device: Smartwatch single-lead ECG monitoring

Continuation of NOACs

ACTIVE COMPARATOR

Participants randomized to the control arm will continue NOAC therapy after randomization. The same intensified rhythm monitoring approach (smartwatch ECG plus scheduled Holter/patch and symptom/opportunistic ECG confirmation) applies.

Drug: NOAC continuation; Device: Smartwatch single-lead ECG monitoring

Interventions

NOAC discontinuation DRUG

Stop NOACs immediately after randomization (experimental arm)

Discontinuation of NOACs

NOAC continuation DRUG

Continue guideline-recommended NOAC therapy after randomization (control arm)

Continuation of NOACs

Smartwatch single-lead ECG monitoring DEVICE

Continuous AF screening with a smartwatch capable of recording single-lead ECG, with ECG confirmation required for diagnosis (PPG abnormalities alone are not diagnostic).

Continuation of NOACs; Discontinuation of NOACs

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria:
• Age 18 to 80 years.
• ±15 to 365±15 days after atrial fibrillation/atrial flutter (AF/AFL) ablation.
• CHA2DS2-VA score ≥2.
• No history of stroke, transient ischemic attack (TIA), or systemic embolism.
• Continuous use of a NOAC since AF/AFL ablation.
• No documented atrial tachyarrhythmia recurrence since ablation.
• No antiarrhythmic drug (AAD) use within the past 2 months.
• Able and willing to provide written informed consent.
• Able and willing to comply with study procedures and follow-up.

You may not qualify if:

• Participants will be excluded if any of the following criteria are present:
• High risk of post-ablation recurrence (e.g. including premature atrial contraction burden \>3% on any ambulatory ECG/Holter recording).
• Moderate-to-severe mitral stenosis (mitral valve area ≤2.0 cm²) or mechanical heart valve.
• Increased bleeding risk, including any of the following:
• Current ISTH major bleeding or clinically relevant non-major bleeding (CRNMB).
• History of non-traumatic major bleeding (e.g., intracranial, intraocular, spinal, retroperitoneal, gastrointestinal, or intra-articular) unless the reversible cause has been permanently eliminated.
• Unresolved intracranial aneurysm/vascular malformation, or active/unhealed gastric or duodenal ulcer.
• General anesthesia surgery within the past 3 months.
• Planned surgery within the next 3 months.
• Known bleeding diathesis (e.g., hemophilia).
• Uncontrolled hypertension (SBP \>180 mmHg and/or DBP \>110 mmHg).
• Hemoglobin \<90 g/L or blood transfusion within 4 weeks prior to enrollment.
• Platelet count \<50 × 10⁹/L.
• End-stage kidney disease (eGFR \<15 mL/min/1.73 m²) or on dialysis.
• Severe liver disease (e.g., esophageal variceal bleeding, ascites, hepatic encephalopathy, or jaundice).

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (22)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, 230022, China

NOT YET RECRUITING

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510080, China

NOT YET RECRUITING

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050000, China

NOT YET RECRUITING

The First Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

NOT YET RECRUITING

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150085, China

NOT YET RECRUITING

Luohe Central Hospital

Luohe, Henan, 462003, China

NOT YET RECRUITING

Henan Provincial Chest Hospital

Zhengzhou, Henan, 450003, China

NOT YET RECRUITING

Wuhan Asia Heart Hospital

Wuhan, Hubei, 430022, China

NOT YET RECRUITING

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

NOT YET RECRUITING

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210036, China

NOT YET RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221002, China

NOT YET RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

NOT YET RECRUITING

First Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, 116023, China

NOT YET RECRUITING

Shengjing Hospital Affiliated to China Medical University

Shenyang, Liaoning, 110004, China

NOT YET RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

NOT YET RECRUITING

Liaocheng People's Hospital

Liaocheng, Shandong, 252000, China

NOT YET RECRUITING

Liaocheng Heart Hospital

Liaocheng, Shandong, 252299, China

NOT YET RECRUITING

Chengdu Fifth People's Hospital

Chengdu, Sichuan, 611130, China

NOT YET RECRUITING

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

NOT YET RECRUITING

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

NOT YET RECRUITING

Ningbo No.2 Hospital

Ningbo, Zhejiang, 315000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Thromboembolism; Hemorrhage

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Embolism and Thrombosis; Vascular Diseases

Study Officials

• Changsheng Ma, MD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

• Caihua Sang

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liu He, PhD

CONTACT

13810720787; theliu@139.com

Caihua Sang, MD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 11, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (22)