Back to resultsImplementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement
Primary Purpose
Heart Failure
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adaptiv CRT
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, CRT, Cardiac Recynchronization Therapy, left bundle branch block, atrio-ventricular conduction
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Stern Cardiovascular Foundation
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Adaptiv CRT
Arm Description
Adaptiv CRT algorithm in Medtronic FDA approved CRT devices to be programmed as ON at 6 month follow-up visit
Outcomes
Primary Outcome Measures
Ejection fraction
Change in ejection fraction as determined by echocardiography 6 months following the addition of adaptive CRT as compared to the same end points following patient management optimization
NYHA functional class
Change in NYHA functional class 6 months following the addition of adaptive CRT as compared to the same end points following patient management optimization
Secondary Outcome Measures
Atrial fibrillation burden
Atrial fibrillation burden and/or progression to permanent atrial fibrillation as determined by device interrogation and review
Heart failure hospitalizations
Amount and severity of heart failure hospitalizations and health care utilization as reported by subjects
Left ventricular end systolic volume
As determined by echocardiographic evidence
Time to first appropriate therapy for VT and/or VF
Time determined by device interrogation from sensing to response
Percentage of RV synchronized LV pacing
Percentage determined by device interrogation and compared to clinical outcomes
Full Information
NCT ID
NCT03305393
First Posted
August 15, 2017
Last Updated
September 17, 2019
Sponsor
Stern Cardiovascular Foundation, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03305393
Brief Title
Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement
Official Title
Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
Only one subject was enrolled and that subject was Lost to Follow Up. Decision was made to terminate the study.
Study Start Date
June 11, 2017 (Actual)
Primary Completion Date
July 3, 2018 (Actual)
Study Completion Date
July 3, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stern Cardiovascular Foundation, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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) observational study. The purpose of this clinical study is to test the hypothesis that market-released CRT devices, which contain the AdaptivCRT (aCRT) algorithm have an incremental benefit in improving CRT response in a chronic CRT non responder population with left bundle branch block (LBBB) and normal atrio-ventricular (AV) condition compared to CRT devices with traditional biventricular pacing delivery methods at generator replacement.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart Failure, CRT, Cardiac Recynchronization Therapy, left bundle branch block, atrio-ventricular conduction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adaptiv CRT
Arm Type
Other
Arm Description
Adaptiv CRT algorithm in Medtronic FDA approved CRT devices to be programmed as ON at 6 month follow-up visit
Intervention Type
Device
Intervention Name(s)
Adaptiv CRT
Intervention Description
Adaptiv CRT algorithm to be programmed to ON in CRT devices of study patients at 6 month follow-up visit
Primary Outcome Measure Information:
Title
Ejection fraction
Description
Change in ejection fraction as determined by echocardiography 6 months following the addition of adaptive CRT as compared to the same end points following patient management optimization
Time Frame
12 Months
Title
NYHA functional class
Description
Change in NYHA functional class 6 months following the addition of adaptive CRT as compared to the same end points following patient management optimization
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Atrial fibrillation burden
Description
Atrial fibrillation burden and/or progression to permanent atrial fibrillation as determined by device interrogation and review
Time Frame
12 Months
Title
Heart failure hospitalizations
Description
Amount and severity of heart failure hospitalizations and health care utilization as reported by subjects
Time Frame
12 months
Title
Left ventricular end systolic volume
Description
As determined by echocardiographic evidence
Time Frame
12 months
Title
Time to first appropriate therapy for VT and/or VF
Description
Time determined by device interrogation from sensing to response
Time Frame
12 months
Title
Percentage of RV synchronized LV pacing
Description
Percentage determined by device interrogation and compared to clinical outcomes
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Facility Information:
Facility Name
Stern Cardiovascular Foundation
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement
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