ECG Belt for CRT Response
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03504020|
Recruitment Status : Completed
First Posted : April 20, 2018
Last Update Posted : July 11, 2022
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: ECG Belt Research System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||498 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||ECG Belt for CRT Response|
|Actual Study Start Date :||July 13, 2018|
|Actual Primary Completion Date :||January 7, 2022|
|Actual Study Completion Date :||April 20, 2022|
Experimental: ECG Belt
The ECG Belt arm will utilize the ECG Belt Research System at implant and all follow up visits.
Device: ECG Belt Research System
The ECG Belt Research System is used to identify the best vector and programming parameters.
No Intervention: Control Arm
Standard CRT through 6 months follow-up.
- Change in left ventricular end systolic volume (LVESV) from baseline to 6 months post-implant. [ Time Frame: baseline to 6 months ]
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): NCT03504020
|Study Chair:||ECG Belt for CRT Response Clinical Research Specialist||Medtronic|