Status:
TERMINATED
Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement
Lead Sponsor:
Stern Cardiovascular Foundation, Inc.
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
IMPROVE RESPONSE is a physician initiated research study. It is a prospective, non-randomized, multi-center, post-market, U.S. Cardiac Resynchronization Therapy (CRT) in heart failure (HF) observation...
Eligibility Criteria
Inclusion
- Normal AV conduction (SAV\<220 ms or PAV\<270 MS)
- Left Bundle Branch Block (defined as \> or = to 140 ms (male) or \> or = 130 (female), QR or rS in leads V1 and V2, and Mid QRS notching or slurring in v 2 of leads V1, V2, V5, V6 and I and aVL.)
- Patient and/or physician assessment or unchanged or worsened heart failure status at the time of recommended replacement time (RRT) for previous CRT device.
- Sinus Rhythm at the time of enrollment
Exclusion
- Moderate to severe Aortic Stenosis
- Moderate to severe Mitral Regurgitation
- Patient age \<18 years old
- AF burden \>15%
- Severe pulmonary disease requiring supplemental oxygen use
- ESRD
- System Modification at RRT Generator Changeout
- AdaptivCRT prior to enrollment
- Expected patient longevity \< 1 year
- Persistant or chronic atrial fibriliation
- Women who are pregnant or who plan to become pregnant during the clinical trial
Key Trial Info
Start Date :
June 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2018
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03305393
Start Date
June 11 2017
End Date
July 3 2018
Last Update
September 19 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stern Cardiovascular Foundation
Germantown, Tennessee, United States, 38138