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

• ClinicalTrials.gov Identifier: NCT05855135
• Recruitment Status: Recruiting
• First Posted: May 11, 2023
• Last Update Posted: January 23, 2024
• Sponsor: Impulse Dynamics
• Information provided by (Responsible Party): Impulse Dynamics

Tracking Information

• First Submitted Date: May 3, 2023
• First Posted Date: May 11, 2023
• Last Update Posted Date: January 23, 2024
• Actual Study Start Date: May 17, 2023
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 3, 2023)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 3, 2023)

Inappropriate Shock Rate out to 6-months (Secondary Safety Objective) [ Time Frame: Implant to 6 months ]

Evaluate the incidence of inappropriate ICD shocks through the time when the last subject enrolled completes the 6-month visit.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: May 3, 2023)

• Inappropriate Shock Rate out to 2-years [ Time Frame: Implant 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.
• Charging non-compliance [ Time Frame: Implant to 2 years ]
  Evaluate subject charging non-compliance defined as >14 days between interval charging sessions, overall and frequency of non-compliance in the same subject.
• Longitudinal levels of activity [ Time Frame: Implant to 2 years ]
  Track longitudinal levels of activity weekly via OPTIhome (when available) and identification of trends.
• Battery degradation and longevity [ Time Frame: Implant to 2 years ]
  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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Assessment of Combined CCM and ICD Device in HFrEF
• 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Treatment

Condition

• 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

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.

Study Arms

Experimental: CCM-D Implant

The subject is implanted with the CCM-D device.

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 3, 2023): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2025
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Elizabeth Shaji; (856) 434-7957; eshaji@impulsedynamics.com

Contact: Jozef Murar; jmurar@impulsedynamics.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05855135
• Other Study ID Numbers: RG_PRO_345
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Impulse Dynamics
• Original Responsible Party: Same as current
• Current Study Sponsor: Impulse Dynamics
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Niraj Varma, MD, PhD; The Cleveland Clinic
• Principal Investigator: Nir Uriel, MD; Columbia University

• PRS Account: Impulse Dynamics
• Verification Date: January 2024