Implementation of a Protocol Utilizing Adaptive CRT in a... | NCT03305393

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

NCT03305393

Sponsor

Stern Cardiovascular Foundation, Inc.

Status

Terminated

Last Update Posted

Sep 19, 2019Actual

Enrollment

1Actual

Phase

Not Applicable

Conditions

Heart Failure

Interventions

Adaptiv CRT

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Only one subject was enrolled and that subject was Lost to Follow Up. Decision was made to terminate the study.

Expanded Access Info

Start Date

Jun 11, 2017Actual

Primary Completion Date

Jul 3, 2018Actual

Completion Date

Jul 3, 2018Actual

First Submitted Date

Aug 15, 2017

First Submission Date that Met QC Criteria

Oct 3, 2017

First Posted Date

Oct 10, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2019

Last Update Posted Date

Sep 19, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stern Cardiovascular Foundation		Germantown	Tennessee	38138	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006333	Heart Failure
D002037	Bundle-Branch Block

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D006327	Heart Block
D001145	Arrhythmias, Cardiac

Browse Leaves

Not provided

Browse Branches

Not provided