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Completed

NCT Number: NCT03033134

A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Using BSJ003W

The purpose of this study is to confirm the safety and effectiveness of the BSJ003W in Japanese patients with non-valvular atrial fibrillation at increased risk of thromboembolism in Japanese Clinical environment

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Key information

Conditions

Atrial Fibrillation Non-Rheumatic

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kokura Memorial Hospital, Kitakyushu, Fukuoka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject is Japanese, over 20 years old and provides written informed consent to participate in the trial
  • The subject has documented paroxysmal, persistent or permanent non-valvular atrial fibrillation
  • The subject has a calculated CHA2DS2-VASc score of 2 or greater and is recommended for long-term oral anti-coagulation therapy
  • The subject is deemed by their physicians to be suitable for anticoagulant therapy and have an appropriate rationale to seek a non-pharmacologic alternative to warfarin
  • The subject is eligible to come off warfarin therapy if the LAA (left atrial appendage) is sealed (i.e. the subject has no other conditions that would require warfarin therapy).

Exclusion criteria

  • The subject has a prior stroke (ischemic or hemorrhagic) or transient ischemic attack within the 90 days prior to consent
  • The subject has had a myocardial infarction either non-ST elevation or ST elevation myocardial infarction within 90 days prior to consent with or without intervention
  • The subject had or is planning to have any cardiac (e.g. cardioversion, coronary angiogram, percutaneous coronary intervention, cardiac ablation, etc.) or non-cardiac invasive or surgical procedure (e.g. cataract surgery, endoscopy, etc.) within 30 days prior or 45 days after the BSJ003W implant
  • The subject has a history of atrial septal repair or has an atrial septal defect/persistent foramen ovale device
  • The subject has an implanted mechanical valve prosthesis in any position
  • The subject currently New York Heart Association class IV congestive heart failure
  • The subject is contraindicated to aspirin
  • The subject is contraindicated or seriously allergic to thienopyridine
  • The subject is of childbearing potential and is, or plans to become pregnant during the time of the study
  • The subject is not able and willing to return for required follow-up visits and examinations
  • Subjects who are currently enrolled in another investigational study (of which primary endpoint follow-up have not been completed yet).
  • The subject has other reason not to be eligible for this study per investigators' discretion.

Treatment and study plan

BSJ003W

Device

BSJ003W implant

Primary outcomes

  1. Number of Participants With Complications; One of the Following Events

    Time frame: Between the time of implant and within 7 days following the procedure or by hospital discharge, whichever is later

    All-cause death, ischemic stroke, systemic embolism, or device- or procedure- related events requiring open cardiac surgery or major endovascular intervention such as pseudoaneurysm repair, arteriolar-venular fistula repair, or other major endovascular repair.

  2. Number of Participants With One of the Following Events: Stroke (All/ Ischemic/ Hemorrhagic), Systemic Embolism and Cardiovascular(CV) Death (Including Unexplained Cause)

    Time frame: 24-month

    The occurrence of composite events including stroke (all/ ischemic/ hemorrhagic), systemic embolism and cardiovascular death (including unexplained cause) till 6-month post implant

  3. The Rate of Effective Left Atrial Appendage (LAA) Closure

    Time frame: 45-day, 6-month, 12-month

    The effective LAA closure is defined as peri-device flow <= 5mm demonstrated by TEE.

    TEE measurements will be assessed by an independent Core Laboratory.

Secondary outcomes

  1. Number of Participants With Major Bleeding

    Time frame: 24-month

    Major bleeding is defined as per BARC bleeding definition type 3 or 5.

    Type 3 Type 3a: Overt bleeding plus hemoglobin drop of 3 to 5 g/dL* (provided hemoglobin drop is related to bleed), Any transfusion with overt bleeding

    Type 3b: Overt bleeding plus hemoglobin drop 5 g/dL* (provided hemoglobin drop is related to bleed) Cardiac tamponade, Bleeding requiring surgical intervention for control (excluding dental/nasal/skin/hemorrhoid), Bleeding requiring intravenous vasoactive agents

    Type 3c: Intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal), Subcategories confirmed by autopsy or imaging or lumbar puncture Intraocular bleed compromising vision

    Type 5: fatal bleeding Type 5a: Probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious Type 5b: Definite fatal bleeding; overt bleeding or autopsy or imaging confirmation

  2. Number of Participants With Clinically Overt Non-fatal Bleeding

    Time frame: 24-month

    Clinically overt non-fatal bleeding is defined as per BARC bleeding definition type 2.

    Type 2: any overt, actionable sign of hemorrhage (eg, more bleeding than would be expected for a clinical circumstance, including bleeding found by imaging alone) that does not fit the criteria for type 3, 4, or 5 but does meet at least one of the following criteria: (1) requiring nonsurgical, medical intervention by a healthcare professional, (2) leading to hospitalization or increased level of care, or (3) prompting evaluation

  3. Number of Participants With Ischemic Stroke or Systemic Embolism

    Time frame: 24-month

    The occurrence of ischemic stroke or systemic embolism (excluding 7 days after implanting or day after hospital discharge whichever is the later)

Other outcomes

  1. Technical Success Rate

    Time frame: Implant Day

    Technical Success defined as successful delivery and release of BSJ003W into the LAA including successful recapture and retrieval if necessary.

  2. Warfarin Discontinuation Rate

    Time frame: 45-day, 6-month, 12-month

    Warfarin discontinuation rate per protocol. If the TEE shows adequate seal of the LAA with a jet around the device <= 5mm, warfarin therapy should be discontinued.

    Some patients restarted warfarin therapy due to the reasons other than the status of LAA closure.

Sponsors and collaborators

Lead sponsor

Boston Scientific Japan K.K.

Industry

Registry information

Official study title

A Study to Evaluate the Safety and Effectiveness of the Left Atrial Appendage Closure Therapy Using BSJ003W for Patients With Non-valvular Atrial Fibrillation at Increased Risk of ThromboEmbolism in Japanese Medical Environment (SALUTE)

Acronym: SALUTE

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Jan 26, 2017
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.