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Left Atrial Appendage Closure in Combination With Catheter Ablation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03788941
Recruitment Status : Not yet recruiting
First Posted : December 28, 2018
Last Update Posted : December 28, 2018
Sponsor:
Information provided by (Responsible Party):
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief Summary:

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.

Patients diagnosed with paroxysmal or persistent atrial fibrillation with an age between 18 and 80 years will be enrolled in this study. After enrollment, patients will be divided nonrandomly into two cohorts. In the first cohort, patients will only receive atrial fibrillation ablation. In the other cohort, patients will receive both standard ablation procedure as well as left atrial appendage closure("one-stop" treatment). For each cohort, 180 patients will be included, with an estimated total number of 360 participants in this clinical study. After the procedure, the patients will be followed with a duration of 12 months. During the follow-up, events of atrial arrhythmias, events of stroke/TIA and systematic embolism, bleeding, hospitalization due to heart failure et al. will be identified and recorded. Patients will be followed-up in the 3rd, 9th, 12th months after the ablation procedure or"one-stop" therapy. Items including 12-leads ECG, 24h Holter ECG, transesophageal echocardiography and transthoracic echocardiography will be performed accordingly. Head computed tomography or MRI will also be conducted if necessary. The investigators will only harvest whole blood to determine the biomarkers including NT-proBNP and inflammatory cytokines. Statistics analysis will be performed to compare the differences between the two cohorts in the events of primary and secondary endpoints. The investigators hypothesize that "one-stop" treatment will be superior to catheter ablation alone.


Condition or disease Intervention/treatment
Atrial Fibrillation Procedure: left atrial appendage closure and catheter ablation

Detailed Description:

This study is a prospective and observational clinical trial investigating the efficacy and safety of catheter ablation in combination with left atrial appendage closure in treating patients with atrial fibrillation. The investigators and sponsors will work together to develop research protocols, case report forms, research medical records, and informed consent in accordance with the Declaration of Helsinki. Research related materials will be reported to the Medical Ethics Committee for review and approval. All included patients will sign the informed consent form and followed-up regularly for clinical outcomes and adverse events.

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

  1. Screen out 360 patients in accordance with the inclusion and exclusion criteria. The screening period begins with the subject signing the informed consent form and until the subject begins receiving treatment. Usually, the subject's written informed consent must be obtained prior to any trial-related procedures. If the subject has received physical examinations and laboratory tests within 2 weeks prior to screening after admission, the participants may also sign informed consent and use the results as screening data. After obtaining informed consent, the subject's basic information is recorded in the "subject screening form." The following screening 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. After enrollment, participants will be nonrandomly divided into two cohorts according to patients' medical conditions and willingness to the therapeutic approaches, receiving radiofrequency ablation and the radiofrequency ablation in combination with left atrial appendage closure respectively. 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, echocardiography, transesophageal echocardiography, coronary CT et al., and brain CT or MRI if necessary. participants' medication and symptoms will also be observed and recorded. The incidence of stroke, systemic embolism, and cardiovascular 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.
  4. Collect research data and perform the statistical analysis. For Statistical analysis, the sample size calculation is based on the overall incidence of stroke, systemic embolism, and cardiovascular death events. The study included multiple endpoint tests that would use a 5% significance level with a test efficacy of 90%. Assume that 10% of patients have withdrawn from the middle and 10% have lost follow-up. According to the literature and most experts, the total proportion of stroke, systemic embolism, and cardiovascular death in patients with atrial fibrillation is 6.3/100 person-years. The investigators estimate that with the use of radiofrequency ablation in combination with left atrial appendage closure, the proportion of events is 2.0/100 person-years. According to the sample size estimation formula, the number of trials should be 360 patients (180 in each group).

The overall timing of the trial: patients' enrollment and treatment will be completed from January 2019 to December 2020. The last participants will be followed-up for 1 year after completion of the treatment. It is expected that the trial will be completed in a total of 36 months by December 2021.

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Study Type : Observational
Estimated Enrollment : 360 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Efficacy and Safety of Left Atrial Appendage Closure in Combination With Catheter Ablation in Patients With Atrial Fibrillation
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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 Name: left atrial appendage occlusion; radiofrequency ablation

Catheter ablation
Patients will only receive catheter ablation of atrial fibrillation for treatment.



Primary Outcome Measures :
  1. The incidence of stroke/TIA events as assessed by CT scans [ Time Frame: 12 months 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.

  2. The incidence of systemic embolism events as assessed by CT scans [ Time Frame: 12 months after the procedure. ]
    The incidence of systemic embolism events in the participants will be reported. Systemic embolism usually refers to pulmonary artery embolism and embolism in the arteries of other organs like kidney, spleen and mesentery et al.. CT scans are effective in diagnosing an artery embolism.


Secondary Outcome Measures :
  1. Rate of maintenance of sinus rhythm as assessed by electrocardiogram [ Time Frame: 12 months after the procedure. ]
    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.

  2. Number of participants with early-term complications [ Time Frame: 12 months 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.


Biospecimen Retention:   Samples Without DNA
The investigators will only harvest whole blood to determine the biomarkers of heart failure and inflammation in the plasma. The investigators will not retain any tissue or other specimens or extract DNA from tissues or plasma.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
  1. History of paroxysmal/sustained atrial fibrillation (evidence includes any of the following: Holter or 12-lead ECG recorder to atrial fibrillation);
  2. One or more drug treatments are ineffective or patients unwilling to be treated with long-term drugs;
  3. Unable to tolerate drug treatment or with contraindications
  4. CHA2DS2-VASc score ≥ 2 and/or HAS-BLED score ≥ 3
  5. Provide informed consent to participate in the study, follow-up trials and assessment procedures;
  6. with an age between 18-80 years
Criteria

Inclusion Criteria:

  1. History of paroxysmal/sustained atrial fibrillation (evidence includes any of the following: Holter or 12-lead ECG recorder to atrial fibrillation);
  2. One or more drug treatments are ineffective or patients unwilling to be treated with long-term drugs;
  3. Unable to tolerate drug treatment or with contraindications
  4. CHA2DS2-VASc score ≥ 2 and/or HAS-BLED score ≥ 3
  5. Provide informed consent to participate in the study, follow-up trials and assessment procedures;
  6. with an age between 18-80 years

Exclusion Criteria:

  1. There are acute lesions, such as acute phase after myocardial infarction (within 3 months), acute heart attack or 3 months after new cerebral infarction;
  2. On the list of a heart transplant;
  3. Life expectancy is less than 1 year;
  4. There are other bleeding diseases that cannot be treated with anticoagulation;
  5. With left atrial thrombus;
  6. Patients with uncontrolled cancer ;
  7. Obvious liver and kidney dysfunction (and/or ALT, AST is more than 1 times the upper limit of normal, CCr <50%);
  8. previous radiofrequency ablation of atrial fibrillation or cardiac surgery;
  9. Women who are pregnant, breastfeeding or of childbearing age who do not adopt reliable methods of contraception.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788941


Contacts
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Contact: Zhi-Quan Wang, Dr. 86 021 25077275 wangzhiquan@xinhuamed.com.cn

Sponsors and Collaborators
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Yi-Gang Li, Dr. Xinhua Hospital, Shanghai Jiaotong University School of Medicine

Publications of Results:

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Responsible Party: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT03788941    
Other Study ID Numbers: XH-18-015
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: December 28, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes