Assessment of Combined CCM and ICD Device in HFrEF

Heart Failure Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05855135
• Other study ID #: RG_PRO_345
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2023
• Est. completion date: December 2025

Study information

• Verified date: June 2024
• Source: Impulse Dynamics
• Contact: Elizabeth Shaji
• Phone: (856) 434-7957
• Email: eshaji[@]impulsedynamics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Individuals must meet all the following:

1. Patient is aged 18 years or older;

2. Patient meets the Stage C or D criteria of the Universal Definition of Heart Failure ;

3. Patient has HFrEF (LVEF =40%);

4. Patient is on GDMT for heart failure;

5. Patient has a Class I or Class II indication for an ICD

6. Patient has a reasonable expectation of meaningful survival of > 1 year;

7. Patient has either non-ischemic cardiomyopathy or ischemic cardiomyopathy and is at least 40 days post-MI, if an MI occurred;

8. 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:

1. Patients should not have severe AI or AS, and should not have MS; additionally, patients undergoing DE testing should not have severe MR;

2. Patients who have undergone mitral valve repair or clip within 90 days prior to study consent;

3. Cardiac surgery within 90 days or a PCI procedure within 30 days prior to study consent;

4. Prior heart transplant or ventricular assist device;

5. Implanted mechanical tricuspid valve;

6. PR interval greater than 375ms or advanced AV block;

7. In situ S-ICD, pacemaker, or CRT device;

8. Indicated for CRT;

9. End stage renal disease, currently on dialysis, or with other major medical disorder (e.g. liver failure, terminal cancer);

10. Indicated for permanent bradyarrhythmia pacing;

11. Unstable angina pectoris within 30 days prior to study consent;

12. Pregnant or planning to become pregnant during the study;

13. 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.

14. Other criteria that preclude Optimizer INTEGRA CCM-D implantation and/or CCM therapy, as determined by Investigator.

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Cardiomyopathies
• Death, Sudden, Cardiac
• Heart Arrest
• Heart Failure
• Heart Failure With Reduced Ejection Fraction
• Implantable Defibrillator User
• Ischemic Cardiomyopathy
• Non-ischemic Cardiomyopathy
• Sudden Cardiac Arrest
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Fibrillation
• Ventricular Tachycardia

Intervention

Device:
• OPTIMIZER® Integra CCM-D System (Treatment Arm)
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.

Locations

Country	Name	City	State
United States	Texas Cardiac Arrhythmia Research Foundation	Austin	Texas
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Bryn Mawr Medical Specialists Association	Bryn Mawr	Pennsylvania
United States	Virtua	Cherry Hill	New Jersey
United States	Cleveland Clinic	Cleveland	Ohio
United States	The Ohio State University Wexner Medical Center	Columbus	Ohio
United States	Medical City Dallas	Dallas	Texas
United States	Broward Health Medical Center	Fort Lauderdale	Florida
United States	The Heart House - Cardiovascular Associates of the Delaware Valley	Haddon Heights	New Jersey
United States	Saint Luke's Hospital	Kansas City	Missouri
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Lancaster General Hospital	Lancaster	Pennsylvania
United States	Baptist Health Lexington	Lexington	Kentucky
United States	University of Southern California	Los Angeles	California
United States	Centra Health	Lynchburg	Virginia
United States	CardioVascular Associates of Mesa	Mesa	Arizona
United States	Chan Heart Rhythm Institute	Mesa	Arizona
United States	Baptist Health South Florida	Miami	Florida
United States	Columbia University Medical Center / NewYork-Presbyterian	New York	New York
United States	Mount Sinai New York	New York	New York
United States	Advent Health Orlando	Orlando	Florida
United States	Penn Presbyterian	Philadelphia	Pennsylvania
United States	Temple University	Philadelphia	Pennsylvania
United States	CVC Cardiovascular Consultants	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Chippenham Hospital	Richmond	Virginia
United States	Honor Health	Scottsdale	Arizona
United States	Christus Trinity Clinic	Tyler	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Impulse Dynamics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Inappropriate Shock Rate out to 2-years	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.	Implant to 2 years
Other	Charging non-compliance	Evaluate subject charging non-compliance defined as >14 days between interval charging sessions, overall and frequency of non-compliance in the same subject.	Implant to 2 years
Other	Longitudinal levels of activity	Track longitudinal levels of activity weekly via OPTIhome (when available) and identification of trends.	Implant to 2 years
Other	Battery degradation and longevity	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.	Implant to 2 years
Primary	Device Effectiveness in Converting Induced Ventricular Fibrillation (Primary Efficacy Objective)	Evaluate the device effectiveness in converting induced VF at the time of implantation.	Implant
Primary	Device-related Complications (Primary Safety Objective)	Evaluate device-related complications through 6-months (excluding lead-related complications).	Implant to 6 months
Secondary	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.	Implant to 6 months