NCT04185142

Brief Summary

Cryoablation combined with left atrial appendage closure is a novel strategy for atrial fibrillation patients. Through long-term follow-up, the investigators aimed to observe the safety and efficacy of the combined procedure in Chinese population.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2015

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2024

Completed
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

8.1 years

First QC Date

November 25, 2019

Last Update Submit

September 29, 2022

Conditions

Atrial Fibrillation

Keywords

Combined procedureCryoballoon ablationLeft atrial appendage closureChinese

Outcome Measures

Primary Outcomes (2)

  • Recurrence of atrial arrhythmia

    The proportion of patients have recurrent atrial arrhythmia, including atrial tachycardia lasting longer than 30 seconds, atrial flutter, and atrial fibrillation. Detected by either ECG or 24 Holter monitor.

    since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.

  • Incidence of stroke

    the proportion of patients have either hemorrhagic or ischemic stroke confirmed by CT or MRI.

    since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.

Secondary Outcomes (13)

  • All-cause death

    since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.

  • Cardiovascular death

    since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.

  • Major hemorrhagic events

    since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.

  • Myocardial infarction

    since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.

  • Peripheral vascular embolism

    since the start of the procedure, third, sixth, twelfth month, and every year after, up to 5 years.

  • +8 more secondary outcomes

Study Arms (1)

combined procedure group

patients underwent cryoballoon ablation and left atrial appendage closure

Combination Product: cryoballoon ablation combining with left atrial appendage closure

Interventions

cryoballoon ablation combining with left atrial appendage closureCOMBINATION_PRODUCT

cryoballoon ablation using either 1st or 2nd generation of cryoballoon and left atrial appendage closure using devices including WATCHMAN, Lefort and Lacbes.

combined procedure group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chinese with documented non-valvular atrial fibrillation who meet the inclusion criteria while without any of the exclusion criteria.

You may qualify if:

  • CHA2DS2-VASc score≥2 or HAS-BLED score≥3,
  • having contraindications to long-term oral anticoagulants (OACs),
  • refuse OAC therapy despite explanation.

You may not qualify if:

  • thrombus in left atrium (LA) or left atrial appendage (LAA) presented and confirmed by transoesophageal echocardiograph (TEE),
  • oversized LA (LA diameter\>65mm by TTE) or LAA (LAA opening\>35mm) through TEE,
  • pericardial effusion (≥4mm by TTE or TEE),
  • hemodynamic unstable patients,
  • patients with active hemorrhagic diseases,
  • ischemic or hemorrhagic stroke within 30 days.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

Related Publications (1)

  • Ren Z, Zheng Y, Zhang J, Yang H, Wu J, Li H, Guo R, Meng W, Zhang J, Sun H, Xu Y, Zhao D. Patients With Larger Left Atrial Appendage Orifice Presented Worse Prognosis Contributed by Acute Heart Failure After Left Atrial Appendage Closure. J Am Heart Assoc. 2022 Sep 20;11(18):e026309. doi: 10.1161/JAHA.122.026309. Epub 2022 Sep 14.

    PMID: 36102232DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Left Atrial Appendage Closure

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cardiac CatheterizationCatheterizationTherapeuticsInvestigative Techniques

Study Officials

  • Yawei Xu, MD, PhD

    Department of Cardiology, Shanghai Tenth People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhongyuan Ren, MD

CONTACT

+86 18862186450cloudyrzy@gmail.com

Dongdong Zhao, MD, PhD

CONTACT

249620601@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief physician

Study Record Dates

First Submitted

November 25, 2019

First Posted

December 4, 2019

Study Start

October 16, 2015

Primary Completion

November 16, 2023

Study Completion

November 16, 2024

Last Updated

October 3, 2022

Record last verified: 2022-09

Locations

CN(1)