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Assessment of Combined CCM and ICD Device in HFrEF (INTEGRA-D)

Primary Purpose

Heart Failure, Heart Failure With Reduced Ejection Fraction, Implantable Defibrillator User

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OPTIMIZER® Integra CCM-D System (Treatment Arm)
Sponsored by
Impulse Dynamics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, HFrEF, Stage C Heart Failure, Stage D Heart Failure, Defibrillation Efficacy Testing, Induced Ventricular Fibrillation, Ventricular fibrillation, Ventricular tachycardia, Implantable cardioverter defibrillator, Sudden cardiac arrest

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Individuals must meet all the following: Patient is aged 18 years or older; Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure ; Patient has HFrEF (LVEF ≤40%); Patient is on GDMT for heart failure; Patient has a Class I or Class II indication for an ICD Patient has a reasonable expectation of meaningful survival of > 1 year; Patient has either non-ischemic cardiomyopathy or ischemic cardiomyopathy and is at least 40 days post-MI, if an MI occurred; Patient is willing to give informed consent, available for scheduled study follow-up visits, and able to complete all testing described in the study protocol at the investigational site location. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: Patients should not have severe AI or AS, and should not have MS; additionally, patients undergoing DE testing should not have severe MR; Patients who have undergone mitral valve repair or clip within 90 days prior to study consent; Cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent; Prior heart transplant or ventricular assist device; Implanted mechanical tricuspid valve; PR interval greater than 375ms or advanced AV block; In situ S-ICD, pacemaker, or CRT device; Indicated for CRT; End stage renal disease, currently on dialysis, or with other major medical disorder (e.g. liver failure, terminal cancer); Indicated for permanent bradyarrhythmia pacing; Unstable angina pectoris within 30 days prior to study consent; Pregnant or planning to become pregnant during the study; Participating in another cardiac investigational device or drug study at the same time (or within 30 days prior to study consent); Note: Registries and other observational studies are acceptable. Other criteria that preclude Optimizer INTEGRA CCM-D implantation and/or CCM therapy, as determined by Investigator.

Sites / Locations

  • CardioVascular Associates of MesaRecruiting
  • Chan Heart Rhythm InstituteRecruiting
  • CVC Cardiovascular ConsultantsRecruiting
  • Honor HealthRecruiting
  • Baptist Health South FloridaRecruiting
  • Advent Health OrlandoRecruiting
  • University of Kansas Medical CenterRecruiting
  • Massachusetts General HospitalRecruiting
  • VirtuaRecruiting
  • Cleveland ClinicRecruiting
  • The Ohio State University Wexner Medical CenterRecruiting
  • Lancaster General HospitalRecruiting
  • Temple UniversityRecruiting
  • Allegheny General HospitalRecruiting
  • Christus Trinity ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CCM-D Implant

Arm Description

The subject is implanted with the CCM-D device.

Outcomes

Primary Outcome Measures

Device Effectiveness in Converting Induced Ventricular Fibrillation (Primary Efficacy Objective)
Evaluate the device effectiveness in converting induced VF at the time of implantation.
Device-related Complications (Primary Safety Objective)
Evaluate device-related complications through 6-months (excluding lead-related complications).

Secondary Outcome Measures

Inappropriate Shock Rate out to 6-months (Secondary Safety Objective)
Evaluate the incidence of inappropriate ICD shocks through the time when the last subject enrolled completes the 6-month visit.

Full Information

First Posted
May 3, 2023
Last Updated
October 24, 2023
Sponsor
Impulse Dynamics
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1. Study Identification

Unique Protocol Identification Number
NCT05855135
Brief Title
Assessment of Combined CCM and ICD Device in HFrEF
Acronym
INTEGRA-D
Official Title
Assessment of the Safety and Efficacy of a Combined Cardiac Contractility Modulation and Implantable Cardioverter Defibrillator Device for Subjects With Heart Failure and Reduced Ejection Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 17, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Impulse Dynamics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of this clinical trial is to demonstrate that the OPTIMIZER® Integra CCM-D System (the "CCM-D System") can safely and effective convert induced ventricular fibrillation (VF) and spontaneous ventricular tachycardia and/or ventricular fibrillation (VT/VF) episodes in subjects with Stage C or D heart failure who remain symptomatic despite being on guideline-directed medical therapy (GDMT), are not indicated for cardiac resynchronization therapy (CRT), and have heart failure with reduced left ventricular ejection fraction (LVEF ≤40%). Eligible subjects will be implanted with the CCM-D System. A subset of subjects will be induced into ventricular fibrillation "on the table" in the implant procedure room. During the follow-up period, inappropriate shock rate and device-related complications will be evaluated. The follow-up period is expected to last at least two years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Heart Failure With Reduced Ejection Fraction, Implantable Defibrillator User, CCM Therapy, Non-ischemic Cardiomyopathy, Ischemic Cardiomyopathy, Sudden Cardiac Arrest, Arrhythmias, Cardiac, Ventricular Tachycardia, Ventricular Fibrillation
Keywords
Heart Failure, HFrEF, Stage C Heart Failure, Stage D Heart Failure, Defibrillation Efficacy Testing, Induced Ventricular Fibrillation, Ventricular fibrillation, Ventricular tachycardia, Implantable cardioverter defibrillator, Sudden cardiac arrest

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm, prospective, multicenter study of 300 subjects that will establish that the device can appropriately sense and convert episodes of induced VF "on the table" in the implant procedure room, spontaneous episodes of VT/VF that occur during the study follow-up period, and ensure that the inappropriate shock rate is not unacceptably high.
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CCM-D Implant
Arm Type
Experimental
Arm Description
The subject is implanted with the CCM-D device.
Intervention Type
Device
Intervention Name(s)
OPTIMIZER® Integra CCM-D System (Treatment Arm)
Intervention Description
The CCM-D System is an implantable cardiac device system that combines cardiac contractility modulation and implantable cardioverter defibrillator (ICD) modules into one device. CCM-D is also known as a "Cardiac Contractility Modulation - Defibrillator". All 300 subjects will be implanted with the CCM-D System and followed for a period of at least two years.
Primary Outcome Measure Information:
Title
Device Effectiveness in Converting Induced Ventricular Fibrillation (Primary Efficacy Objective)
Description
Evaluate the device effectiveness in converting induced VF at the time of implantation.
Time Frame
Implant
Title
Device-related Complications (Primary Safety Objective)
Description
Evaluate device-related complications through 6-months (excluding lead-related complications).
Time Frame
Implant to 6 months
Secondary Outcome Measure Information:
Title
Inappropriate Shock Rate out to 6-months (Secondary Safety Objective)
Description
Evaluate the incidence of inappropriate ICD shocks through the time when the last subject enrolled completes the 6-month visit.
Time Frame
Implant to 6 months
Other Pre-specified Outcome Measures:
Title
Inappropriate Shock Rate out to 2-years
Description
Evaluate the device effectiveness in converting spontaneous VT/VF through the time when the last subject enrolled completes the 6-month visit. Each subject will be followed for 2-years after implant to capture additional spontaneous episodes that may occur.
Time Frame
Implant to 2 years
Title
Charging non-compliance
Description
Evaluate subject charging non-compliance defined as >14 days between interval charging sessions, overall and frequency of non-compliance in the same subject.
Time Frame
Implant to 2 years
Title
Longitudinal levels of activity
Description
Track longitudinal levels of activity weekly via OPTIhome (when available) and identification of trends.
Time Frame
Implant to 2 years
Title
Battery degradation and longevity
Description
Assess battery degradation and longevity either remotely or during an in-person follow-up at 2 years (+/- 60 days) by recording QHR battery voltage as measured by the Integra CCM-D IPG. The measurement under nominal conditions is expected to be 2.85V or higher, consistent with a 20-year device longevity.
Time Frame
Implant to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals must meet all the following: Patient is aged 18 years or older; Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure ; Patient has HFrEF (LVEF ≤40%); Patient is on GDMT for heart failure; Patient has a Class I or Class II indication for an ICD Patient has a reasonable expectation of meaningful survival of > 1 year; Patient has either non-ischemic cardiomyopathy or ischemic cardiomyopathy and is at least 40 days post-MI, if an MI occurred; Patient is willing to give informed consent, available for scheduled study follow-up visits, and able to complete all testing described in the study protocol at the investigational site location. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: Patients should not have severe AI or AS, and should not have MS; additionally, patients undergoing DE testing should not have severe MR; Patients who have undergone mitral valve repair or clip within 90 days prior to study consent; Cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent; Prior heart transplant or ventricular assist device; Implanted mechanical tricuspid valve; PR interval greater than 375ms or advanced AV block; In situ S-ICD, pacemaker, or CRT device; Indicated for CRT; End stage renal disease, currently on dialysis, or with other major medical disorder (e.g. liver failure, terminal cancer); Indicated for permanent bradyarrhythmia pacing; Unstable angina pectoris within 30 days prior to study consent; Pregnant or planning to become pregnant during the study; Participating in another cardiac investigational device or drug study at the same time (or within 30 days prior to study consent); Note: Registries and other observational studies are acceptable. Other criteria that preclude Optimizer INTEGRA CCM-D implantation and/or CCM therapy, as determined by Investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Shaji
Phone
(856) 434-7957
Email
eshaji@impulsedynamics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jozef Murar
Email
jmurar@impulsedynamics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niraj Varma, MD, PhD
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nir Uriel, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CardioVascular Associates of Mesa
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Gitkin
Email
agitkin2@cvam.com
First Name & Middle Initial & Last Name & Degree
Ambrose Panico, DO
Facility Name
Chan Heart Rhythm Institute
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85206
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olivia Rivera
Email
olivia@chanheartrhythm.com
First Name & Middle Initial & Last Name & Degree
Rodrigo Chan, MD
Facility Name
CVC Cardiovascular Consultants
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen Foughi
Email
hfoughi@insightmedr.com
First Name & Middle Initial & Last Name & Degree
Ashish Gupta, MD
First Name & Middle Initial & Last Name & Degree
Yoaav Krauthammer, MD
Facility Name
Honor Health
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Stone
Email
kestone@honorhealth.com
First Name & Middle Initial & Last Name & Degree
Rahul Doshi, MD
Facility Name
Baptist Health South Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ruben Dominguez
Email
ruben.dominguez@baptisthealth.net
First Name & Middle Initial & Last Name & Degree
Mario Pascual, MD
Facility Name
Advent Health Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chantie Garvey
Email
chantie.garvey@adventhealth.com
First Name & Middle Initial & Last Name & Degree
Usman Siddiqui, MD
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kartik Munshi
Email
kmunshi@kumc.edu
First Name & Middle Initial & Last Name & Degree
Rhea Pimentel, MD
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Azzam
Email
cazzam@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Theofanie Mela, MD
Facility Name
Virtua
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08034
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marisa Brown
Email
mbrown3@virtua.org
First Name & Middle Initial & Last Name & Degree
Heath Saltzman, MD
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raquel Rozich
Email
rozichr@ccf.org
First Name & Middle Initial & Last Name & Degree
Bruce Wilkoff, MD
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrianne Miller
Email
adrianne.miller3@osumc.edu
First Name & Middle Initial & Last Name & Degree
Salvatore Savona, MD
Facility Name
Lancaster General Hospital
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Stuart
Email
Sarah.Stuart@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name & Degree
Sandeep Bansal, MD
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianli Hu
Email
jianli.hu@temple.edu
First Name & Middle Initial & Last Name & Degree
Edmond Cronin, MD
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caitlin Phalunas
Email
Caitlin.Phalunas@ahn.org
First Name & Middle Initial & Last Name & Degree
George Shaw, MD
Facility Name
Christus Trinity Clinic
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrian Maples
Email
adrian.maples@christushealth.org
First Name & Middle Initial & Last Name & Degree
Stanislav Weiner, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessment of Combined CCM and ICD Device in HFrEF

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