Cardiac MRI for Optimal Heart Failure Outcomes With CRT Upgrades
|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: NCT03504891|
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : May 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Systolic Heart Failure Paroxysmal VT||Diagnostic Test: MRI prior to CRT Upgrade Diagnostic Test: MRI prior to de novo CRT||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients will have cardiac MRI prior to CRT.|
|Masking:||None (Open Label)|
|Official Title:||Cardiac MRI for Optimal Heart Failure Outcomes With CRT Upgrades|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||January 1, 2020|
|Estimated Study Completion Date :||January 1, 2020|
Experimental: MRI Prior to CRT for Upgrades
MRI will be performed prior to CRT upgrade.
Diagnostic Test: MRI prior to CRT Upgrade
We will perform MRI prior to CRT to inform the optimal CRT implantation strategy in patients with existing devices undergoing upgrades versus those with de novo CRT implants. We will compare outcomes in the two groups.
Active Comparator: MRI Prior to de novo CRT Implants
MRI will be performed prior to de novo CRT implants.
Diagnostic Test: MRI prior to de novo CRT
We will perform MRI prior to de novo CRT implants as the comparison group.
- CRT Response [ Time Frame: 6 months ]CRT Response Based on Change in LVESV After CRT
- Improvement in Peak Oxygen Consumption [ Time Frame: 6 months ]Peak VO2
- Improvement in Short Form (36) Health Survey [ Time Frame: 6 months ]Assesses disability associated with heart failure. We will use the total score, which has a range of 0-100. Lower scores indicate greater disability.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504891
|Contact: Kenneth C Bilchick, MDemail@example.com|
|United States, Virginia|
|University of Virginia Health System||Recruiting|
|Charlottesville, Virginia, United States, 22901|
|Contact: Kenneth C Bilchick, MD 434-924-2465 firstname.lastname@example.org|
|Principal Investigator:||Kenneth C Bilchick, MD||University of Virginia|