HeartLogic Diagnostic for Heart Failure

(Heartlogic ISR Trial)

Not yet recruiting at 1 trial location

Overseen By Robert Pickett, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Robert Pickett

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this trial is to determine if the addition of the Heart Logic diagnostic alerts to standard of care therapies will lessen hospitalizations and improve quality of life in patients with heart failure.

Who Is on the Research Team?

Robert Pickett, MD

Principal Investigator

Ascension Health

Are You a Good Fit for This Trial?

Inclusion Criteria

EF </=35%

HeartLogic capable ICD or CRT-D (Patients with HeartLogic capable ICD or CRT-D can be enrolled at time of de novo implantation or generator change out or at the time of the 2 week wound check. Prior Heart logic capable ICF or CRT-D implants can be enrolled if heart failure hospitalization shows decompensation within six months (prior implants must have at least 1 year battery life)

Age 18 years or older

Exclusion Criteria

Documented noncompliance that limits medication use

Refuse to give consent

Have Life expectancy of less than one-year

What Are the Treatments Tested in This Trial?

Interventions

• HeartLogic Diagnostic

How Is the Trial Designed?

Group I: Active Treatment Arm Active Control 1 Intervention

Heart Logic threshold set to 10 (from 16) will trigger a treatment algorithm, which includes up titration of GDMT

Group II: Control Arm Placebo Group 1 Intervention

Heart Logic transmission of 16 or greater may be reported to the appropriate device clinic staff by Latitude transmission and then referred to the appropriate treating provider. Medication changes will be based upon physician preference/standards. Repeat transmissions, follow-up, laboratory studies will be per physician preference.

Who Is Running the Clinical Trial?

Robert Pickett

Lead Sponsor

Ascension Health

Industry Sponsor

Trials

28

Recruited

543,000+

Boston Scientific Corporation

Industry Sponsor

Trials

758

Recruited

867,000+

Michael F. Mahoney

Boston Scientific Corporation

Chief Executive Officer since 2016

MBA from Wake Forest University, BBA in Finance from the University of Iowa

Kenneth Stein

Boston Scientific Corporation

Chief Medical Officer since 2020

MD from Harvard Medical School, MMSc in Clinical Investigation from Harvard-MIT Division of Health Sciences and Technology