Implementation of a Protocol Utilizing Adaptive CRT in a Normal AV Conduction, CRT Non-Response Population at Generator Replacement

Not Applicable

Terminated

• Conditions: Heart Failure

• Registration Number: NCT03305393
• Lead Sponsor: Stern Cardiovascular Foundation, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-11
• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-10-03
• Study First Posted: 2017-10-10
• Primary Completion: 2018-07-03
• Study Completion: 2018-07-03
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-17
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Ejection fraction	12 Months	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	12 months	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

Name	Time	Method
Left ventricular end systolic volume	12 months	As determined by echocardiographic evidence
Atrial fibrillation burden	12 Months	Atrial fibrillation burden and/or progression to permanent atrial fibrillation as determined by device interrogation and review
Heart failure hospitalizations	12 months	Amount and severity of heart failure hospitalizations and health care utilization as reported by subjects
Time to first appropriate therapy for VT and/or VF	12 months	Time determined by device interrogation from sensing to response
Percentage of RV synchronized LV pacing	12 months	Percentage determined by device interrogation and compared to clinical outcomes

Trial Locations

Locations (1)

Stern Cardiovascular Foundation; 🇺🇸 Germantown, Tennessee, United States