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

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.

Study Overview

• Status: Terminated
• Conditions: Heart Failure
• Intervention / Treatment: Device: Adaptiv CRT

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Stern Cardiovascular Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Adaptiv CRT; Adaptiv CRT algorithm in Medtronic FDA approved CRT devices to be programmed as ON at 6 month follow-up visit	Device: Adaptiv CRT; Adaptiv CRT algorithm to be programmed to ON in CRT devices of study patients at 6 month follow-up visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 Months
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	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Stern Cardiovascular Foundation, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2017
• Primary Completion (Actual): July 3, 2018
• Study Completion (Actual): July 3, 2018

Study Registration Dates

• First Submitted: August 15, 2017
• First Submitted That Met QC Criteria: October 3, 2017
• First Posted (Actual): October 10, 2017

Study Record Updates

• Last Update Posted (Actual): September 19, 2019
• Last Update Submitted That Met QC Criteria: September 17, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Heart Failure; CRT; Cardiac Recynchronization Therapy; left bundle branch block; atrio-ventricular conduction
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: IMPROVE RESPONSE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes