Prospective WCD Post CABG Registry (CABG Registry) | NCT06570902

Studies
Prospective WCD Post CABG Registry (CABG Registry)

NCT06570902

Sponsor

Zoll Medical Corporation

Status

Recruiting

Last Update Posted

Nov 4, 2024Actual

Enrollment

910Estimated

Phase

Not provided

Conditions

Cardiomyopathy Ischemic
Cardiomyopathies
Cardiovascular Diseases
Heart Disease, Ischemic

Interventions

Countries

Germany

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

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 23, 2024Actual

Primary Completion Date

Nov 2029Estimated

Completion Date

May 2030Estimated

First Submitted Date

Jul 28, 2024

First Submission Date that Met QC Criteria

Aug 22, 2024

First Posted Date

Aug 26, 2024Actual

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

Oct 31, 2024

Last Update Posted Date

Nov 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The primary objective is to observe the rate of recovery of ventricular function (EF>35%) after first-time coronary artery bypass graft surgery in patients who were prescribed the wearable cardioverter defibrillator (WCD) post-surgery prior to being discharged after hospitalization as part of standard clinical care.

Detailed Description

The primary objective of this study is to determine the rate of recovery of ventricular function (EF>35%) in patients with ischemic heart failure with reduced ejection fraction (EF ≤35%) after undergoing first time, coronary artery bypass grafting (CABG) procedure while being treated with guideline-directed medical therapy (GDMT). It is anticipated that more patients will have EF recovery as compared to a retrospective register where 54% of isolated CABG patients had EF recovery by end of WCD use (Kuehn et al., 2022), mostly driven by the modern improved usage of GDMT drugs.

This study is designed as a multi-center prospective observational study of patients who underwent first time coronary artery bypass grafting procedure with HFrEF at hospital discharge to test the hypothesis that EF recovery will be improved by end of WCD wear due to increased usage of GDMT. The study will target 20% female enrollment and recruitment will be adjusted if the percentage of female subjects enrolled are far from 20%.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

12 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

910Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
WCD	Device	An FDA-approved, CE marked WCD will be prescribed for up to 3 months of use after hospital discharge, with the option for longer use under physician discretion

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
EF recovery	EF recovery at end of WCD use, usually after 90days of wear. End of WCD use will be determined by the prescribing physician. For this study, EF>35% will be considered as EF recovery.	Enrollment till WCD End of Use

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life (KCCQ	Quality of Life (QoL) information will be collected using the following questionnaires: - Kansas City Cardiomyopathy Questionnaire short form (KCCQ-12)	Enrollment till WCD End of Use, usually up to three month
Quality of Life EQ

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria

Patient underwent first-time CABG surgery <10 days before enrollment.
Patient is prescribed WCD for a primary reason of HF with reduced EF < 35% measured after surgery but before hospital discharge.
Patient is ≥18 years old

Exclusion Criteria:

Patients having combination CABG surgery with heart valve repair.
Patients with prior CABG.
Patients who have an active unipolar pacemaker.
Patients with a physical or mental condition that could impair their ability to properly interact with the WCD.

Patients currently participating in an interventional clinical study. Patients with any skin condition that would prevent wearing the device. Patients with an advanced directive prohibiting resuscitation.

Accepts Healthy Volunteers

Not provided

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

Patients who were prescribed the wearable cardioverter defibrillator (WCD) post-surgery prior to being discharged after hospitalization as part of standard clinical care

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lars Weber, M.Sc.	Contact	015161140498		lweber@zoll.com
Horst-O. Esser	Contact			hesser@zoll.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kerckhoff Klinik	Not yet recruiting	Bad Nauheim	Hesse	61231	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009202	Cardiomyopathies
D002318	Cardiovascular Diseases
D017202	Myocardial Ischemia

Ancestor Terms

ID	Term
D006331	Heart Diseases
D014652	Vascular Diseases

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Browse Branches

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