Left Atrial Appendage Closure in Combination With Catheter Ablation (LAACablation)

January 17, 2023 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

The Efficacy and Safety of Left Atrial Appendage Closure in Combination With Catheter Ablation in Patients With Atrial Fibrillation

This study is a prospective cohort study aimed at investigating the efficacy and safety of left atrial appendage closure in combination with catheter ablation in patients with atrial fibrillation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a prospective cohort investigating the efficacy and safety of catheter ablation in combination with left atrial appendage closure in patients with atrial fibrillation.

This study will be conducted in accordance with the following procedures:

  1. Screen out patients in accordance with the inclusion and exclusion criteria. The following assessments should be made: demographic data, medical history, physical examination, vital signs data, the height and body weight, laboratory parameters, ECG examination, assessment for medication and evaluation for inclusion/exclusion criteria.
  2. Participants receive radiofrequency ablation in combination with left atrial appendage closure. Participants will be assessed and observed carefully during and after the operation.
  3. The participants will be followed-up in the third, ninth and twelfth months after the treatments. The main follow-up includes the review of ECG, 24h Holter monitoring, echocardiography, transesophageal echocardiography, coronary CT et al. and AFEQT questionnaire, and brain CT or MRI if necessary. Participants' medication and symptoms will also be observed and recorded. The incidence of stroke, systemic embolism, transient ischemic attack, major bleeding and all-cause death; the rate of patients maintaining sinus rhythm, hospitalization due to heart failure, and perioperative complications such as pericardial tamponade, wound hematoma and long-term surgery-related complications will be recorded. Adverse events during the trial will also be assessed and recorded.

Study Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Recruiting
        • Xinhua Hospital, Shanghai Jiao Tong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  1. History of paroxysmal/persistent/longstanding persistent atrial fibrillation
  2. Refractory to at least one antiarrhythmic drug or unwilling to receive long-term antiarrhythmic drugs;
  3. With contraindication of longterm anticoagulation or unwilling to receive longterm anticoagulation
  4. CHA2DS2-VASc score ≥ 2 and/or HAS-BLED score ≥ 3
  5. Provide informed consent to participate in the study;
  6. Between 18-90 years

Description

Inclusion Criteria:

  1. History of paroxysmal/persistent/longstanding persistent atrial fibrillation
  2. Refractory to at least one antiarrhythmic drug or unwilling to receive long-term antiarrhythmic drugs;
  3. With contraindication of longterm anticoagulation or unwilling to receive longterm anticoagulation
  4. CHA2DS2-VASc score ≥ 2 and/or HAS-BLED score ≥ 3
  5. Provide informed consent to participate in the study;
  6. Between 18-90 years

Exclusion Criteria:

  1. myocardial infarction within 3 months
  2. Stroke or systemic embolism within 3 months
  3. Plan to receive heart transplantation;
  4. Life expectancy less than 1 year;
  5. Severe bleeding diseases that cannot be treated with short-term anticoagulants;
  6. With left atrial or left atrial appendage thrombus;
  7. With uncontrolled malignant tumor ;
  8. Obvious liver and kidney dysfunction (ALT, AST more than 2 times the upper limit of normal, or CCr <50%);
  9. Women who are pregnant, or breastfeeding.
  10. Other conditions not suitable to the combined procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LAAC plus Catheter ablation
Patients will receive both left atrial appendage closure and catheter ablation of atrial fibrillation for treatment.
Procedure: left atrial appendage closure and catheter ablation

Left atrial appendage closure (LAAC) is a treatment strategy to reduce the risk of left atrial appendage blood clots from entering the bloodstream and causing a stroke in patients with non-valvular atrial fibrillation (AF).

Catheter ablation is a procedure used to remove or terminate a faulty electrical pathway or pathological sites from sections of the hearts of those who are prone to developing cardiac arrhythmias such as atrial fibrillation, atrial flutter, supraventricular tachycardias (SVT) and Wolff-Parkinson-White syndrome (WPW syndrome). The ablation procedure can be classified by energy source: radiofrequency ablation and cryoablation.

Other Names:
  • left atrial appendage occlusion; radiofrequency ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stroke/TIA/systemic embolism
Time Frame: long-term after the procedure.
The incidence of stroke/TIA events in the participants will be reported. Participants with clinical manifestations of stroke/TIA will undergo neurological examination and CT scans for diagnosis.
long-term after the procedure.
Major bleeding
Time Frame: long-term after the procedure.
The incidence of major bleeding in the participants will be reported.
long-term after the procedure.
Death
Time Frame: long-term after the procedure.
all-cause death
long-term after the procedure.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
maintenance of sinus rhythm
Time Frame: after the procedure outside the 3-month blanking period
This refers to the percentage of patients who maintain sinus rhythm after catheter ablation or catheter ablation in combination with left atrial appendage closure. Electrocardiogram can be used to diagnose sinus rhythm or arrhythmias.
after the procedure outside the 3-month blanking period
procedure-related complications
Time Frame: after the procedure.
These are usually refer to perioperative complications such as cardiac tamponade, lesion hematoma and pseudoaneurysm et al. which are related to the manipulation of operator. Diagnostic ultrasound imaging can efficiently identify these complications.
after the procedure.
Heart failure rehospitalization
Time Frame: after the procedure.
acute heart failure leading to hospitalization
after the procedure.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Atrial fibrillation effects on quality-of-life (AFEQT) scores
Time Frame: at baseline and after the procedure
At baseline and at the 1-year follow-up visit, patients were required to complete a 20-item questionnaire based on the AF effects on quality-of-life (QoL) (AFEQT, http://www.afeqt.org) measure. The 20-item AFEQT survey evaluated 4 domains regarding the QoL assessment and the perception of treatment, i.e., symptoms, daily activities, treatment-related concerns, and treatment satisfaction. The first three domains constituted the global score. The scores of each individual domain and the global score ranged between 0 and 100, with "100" representing the best health status and "0" being the worst health status possible. A validated culturally and linguistically translated version of the AFEQT for China was used.
at baseline and after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigators

  • Principal Investigator: Yi-Gang Li, Dr., Xinhua Hospital, Shanghai Jiaotong University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

December 17, 2018

First Submitted That Met QC Criteria

December 24, 2018

First Posted (Actual)

December 28, 2018

Study Record Updates

Last Update Posted (Actual)

January 19, 2023

Last Update Submitted That Met QC Criteria

January 17, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-18-015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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