LUX-Dx TRENDS Evaluates Diagnostics Sensors in Heart Failure Patients Receiving Boston Scientific's Investigational ICM System.
|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: NCT04790344|
Recruitment Status : Recruiting
First Posted : March 10, 2021
Last Update Posted : May 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: Investigational LUX-Dx ICM Implant||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||415 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Physiologic Sensor data will be blinded to participants and care providers. LUX-Dx ICM commercial features will be Open Label.|
|Official Title:||LUX-Dx Heart Failure Sensors in an Insertable Cardiac Monitor System Clinical Study (LUX-Dx TRENDS)|
|Actual Study Start Date :||March 20, 2021|
|Estimated Primary Completion Date :||September 2025|
|Estimated Study Completion Date :||September 2025|
Experimental: Treatment Arm
All study subjects belong to Treatment Arm, which is receiving investigational LUX-Dx ICM device.
Device: Investigational LUX-Dx ICM Implant
All subject will receive an investigational version of the LUX-Dx ICM device.
- Heart Failure Event Related Data will be assessed in all subjects through collection of reportable events and subsequent adjudication by the CEC. [ Time Frame: Through study completion of approximately 4.5 year ]
Heart Failure (HF) event is defined as:
- HF Hospitalization: subject is admitted with a calendar date change with signs/symptoms of congestive heart failure (CHF) and receives unscheduled augmented HF therapy with oral or intravenous medications, ultrafiltration therapy or other parenteral therapy.
- HF Outpatient Visit: subject has signs/symptoms of CHF, and receives unscheduled intravenous decongestive therapy in a setting that does not involve a hospitalization with a calendar date change (e.g.: ER visit, HF clinic, primary care clinic, etc.).
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): NCT04790344
|Contact: Alysia Rosnerfirstname.lastname@example.org|
|Contact: Ming Duanmoemail@example.com|
|Principal Investigator:||Scott Solomon, MD||Brigham and Women's Hospital|
|Principal Investigator:||Elaine Wan, MD||Columbia University|