Extended ECG Monitoring in HCM Patients (EXAMINE-HCM)
|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: NCT04056715|
Recruitment Status : Not yet recruiting
First Posted : August 14, 2019
Last Update Posted : August 19, 2019
|Condition or disease||Intervention/treatment|
|Hypertrophic Cardiomyopathy Nonsustained Ventricular Tachycardia Ventricular Tachycardia Atrial Fibrillation Arrhythmia||Device: Zio XT|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Extended Ambulatory Monitoring With iRhythm Zio XT Improves Care of Patients With Hypertrophic Cardiomyopathy|
|Estimated Study Start Date :||September 8, 2019|
|Estimated Primary Completion Date :||October 1, 2021|
|Estimated Study Completion Date :||November 1, 2022|
Eligible HCM subjects will be monitored for arrhythmias with a 2-week ECG patch.
Device: Zio XT
ambulatory cardiac monitoring device
- Total number of nsVT runs through 14 days of ambulatory cardiac monitoring, as compared to the first 48 hours. [ Time Frame: 14 days ]Compare the number of nsVT runs detected between the first 48 hours vs 2 weeks of ambulatory cardiac monitoring.
- Total number of atrial fibrillation runs through 14 days of ambulatory cardiac monitoring, as compared to the first 48 hours. [ Time Frame: 14 days ]Compare the number of AF runs detected between the first 48 hours vs 2 weeks of ambulatory cardiac monitoring.
- Number of clinical management decisions based on 14 days of ambulatory cardiac monitoring, as compared to the first 48 hours ambulatory cardiac monitoring. [ Time Frame: 14 days ]Compare the number clinical decisions based on the first 48 hours vs 14 days of ambulatory cardiac monitoring.
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): NCT04056715
|Contact: Daniel Higginsemail@example.com|
|Contact: Gaurav Dasfirstname.lastname@example.org|
|United States, Massachusetts|
|Tufts Medical Center||Not yet recruiting|
|Boston, Massachusetts, United States, 02111|
|Contact: Martin Maron, MD|
|Principal Investigator:||Martin Maron, MD||Tufts Medical Center|