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

NCT03305393 | Terminated FDA Device

• 1 other identifier: IMPROVE RESPONSE
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

Heart Failure; CRT; Cardiac Recynchronization Therapy; left bundle branch block; atrio-ventricular conduction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Atrial fibrillation burden

  12 Months

• Heart failure hospitalizations

  12 months

• Left ventricular end systolic volume

  12 months

• Time to first appropriate therapy for VT and/or VF

  12 months

• Percentage of RV synchronized LV pacing

  12 months

Study Arms (1)

Adaptiv CRT

OTHER

Adaptiv CRT algorithm in Medtronic FDA approved CRT devices to be programmed as ON at 6 month follow-up visit

Device: Adaptiv CRT

Interventions

Adaptiv CRT DEVICE

Adaptiv CRT algorithm to be programmed to ON in CRT devices of study patients at 6 month follow-up visit

Adaptiv CRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stern Cardiovascular Foundation, Inc.: lead

Study Sites (1)

Stern Cardiovascular Foundation

Germantown, Tennessee, 38138, United States

Location

MeSH Terms

Conditions

Heart Failure; Bundle-Branch Block

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Heart Block; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2017
• First Posted: October 10, 2017
• Study Start: June 11, 2017
• Primary Completion: July 3, 2018
• Study Completion: July 3, 2018
• Last Updated: September 19, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)