Autonomic Regulation Therapy in Heart Failure With Preser... | NCT03163030

Studies
Autonomic Regulation Therapy in Heart Failure With Preserved Ejection Fraction

NCT03163030

Sponsor

Cyberonics, Inc.

Status

Completed

Last Update Posted

May 6, 2023Actual

Enrollment

52Actual

Phase

Not Applicable

Conditions

Congestive Heart Failure

Interventions

Vagus Nerve Stimulation (VNS)

Countries

India

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

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014Actual

Primary Completion Date

Dec 2019Actual

Completion Date

Dec 2021Actual

First Submitted Date

May 19, 2017

First Submission Date that Met QC Criteria

May 19, 2017

First Posted Date

May 22, 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

May 2, 2023

Last Update Posted Date

May 6, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

The ANTHEM-HFpEF Study is designed to demonstrate the safety and efficacy of vagus nerve stimulation (VNS) with the Cyberonics VNS Therapy System for the treatment of subjects with symptomatic heart failure with preserved and mid-range ejection fraction.

Detailed Description

Heart failure patients will be enrolled and implanted with a cervical VNS system on the right side. After a 2-week post-implantation recovery period and a 10-week stimulation titration period, continuous periodic stimulation will be performed for 12 months, with data collection at 3, 6, 9, and 12 months.

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

52Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Therapy	Experimental	Right Cervical Vagus Nerve Stimulation (VNS)	Device: Vagus Nerve Stimulation (VNS)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vagus Nerve Stimulation (VNS)	Device	Electrical Stimulation of the Vagus Nerve	Therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse Events	Incidence of procedure and device-related complications	12 months

Secondary Outcomes

Measure	Description	Time Frame
Cardiac Size (LAVI)	Left atrial volume index	12 months
Functional Status (6MWD)	6-minute walk distance	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with symptomatic heart failure, New York Heart Association (NYHA) class II/III with preserved and mid-range EF (≥40%).

Exclusion Criteria:

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

Name	Affiliation	Role
Imad Libbus, Ph.D	Cyberonics, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Krishna Institute of Medical Science		Secunderabad			India

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36934987	Result	Kumar HU, Nearing BD, Mittal S, Premchand RK, Libbus I, DiCarlo LA, Amurthur B, KenKnight BH, Anand IS, Verrier RL. Autonomic regulation therapy in chronic heart failure with preserved/mildly reduced ejection fraction: ANTHEM-HFpEF study results. Int J Cardiol. 2023 Jun 15;381:37-44. doi: 10.1016/j.ijcard.2023.03.030. Epub 2023 Mar 17.

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases

ID	Term
D004599	Electric Stimulation Therapy
D013812	Therapeutics