Arrythmia, Atrial Fibrillation
Conditions
Keywords
Impulse Dynamics Optimizer Device, Heart failure, Cardiovascular implantable electronic device, Atrial Fibrillation, Reduced ejection fraction, Internal cardioverter defibrillator, Permanent pacemaker, Arrythmia, Cardiac Contractility Modulation
Brief summary
The Impulse Dynamics Optimizer Device is a Food and Drug Administration (FDA) approved; commercially available device indicated for patients with heart failure with reduced ejection fraction (HFrEF). Many candidates of this device have a previously implanted cardiovascular implantable electronic device (CIED)- internal cardioverter defibrillator (ICD) or permanent pacemaker (PM). Patients with heart failure are at high risk for both atrial and ventricular cardiac arrhythmias. The aim of this study is to evaluate patients for Atrial fibrillation (AF) burden episode data obtained from interrogation of their CIED 8 months or greater after Optimizer implant and compare arrhythmia burden 6 months before Optimizer Cardiac Contractility Modulation (CCM) device insertion to 8 months or greater after Optimizer insertion (after 2 month blanking period).
Interventions
DEVICEImpulse Dynamics Optimizer Device
The Impulse Dynamics Optimizer is indicated for patients with New York Heart Association (NYHA) class III congestive heart failure (CHF) with left ventricular ejection fraction (LVEF) between 25 and 45% who are not candidates for cardiac resynchronization therapy. The Optimizer device requires a minimally invasive implant by a cardiac electrophysiologist with two transvenous pacemaker wires implanted into the right ventricular septum and attached to a generator in an infraclavicular region, much like a pacemaker. The Optimizer device provides CCM through improved calcium handling and has been shown to reverse the negative remodeling of the left ventricle seen in HFrEF and improve left ventricular contractile strength.
Sponsors
Impulse Dynamics
Hackensack Meridian Health
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 1%≤AF burden≤99% in the 6 month period prior to Optimizer implant as documented the patient's CIED 2. 18 years of age or older on day of signing consent 3. Any gender 4. Functional pacemaker or ICD and using remote follow-up for their CEID 5. Not scheduled for planned catheter ablation or cardioversion 6. Ability to sign consent in English or Spanish
Exclusion criteria
1. Permanent atrial fibrillation 2. Pregnancy (in prospective arm only) 3. Expected survival \<1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Atrial Fibrillation (AF) Burden | 8 months post optimizer implantation | Compare the AF burden noted 6 months pre Optimizer implant to 6 post Optimizer months (post Optimizer months 3-8), after 2 month blanking period |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Retrospective Patients with available data for 6 months before the implantation of the Optimizer implantation and at least 8 months after the implantation of the optimizer at the time the study is initiated and patients with available data for 6 months before the implantation of the Optimizer implantation, but less than 8 months of follow up after Optimizer implantation at the time of the study initiation. | 2 |
| Total | 2 |
Baseline characteristics
| Characteristic | Retrospective |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 80 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 1 Participants |
| Region of Enrollment United States | 2 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Change in Atrial Fibrillation (AF) Burden
Compare the AF burden noted 6 months pre Optimizer implant to 6 post Optimizer months (post Optimizer months 3-8), after 2 month blanking period
Time frame: 8 months post optimizer implantation
Population: AF burden was defined as the average minutes of AF/day. Outcome is reported at the pre implantation (pre-ccm) and at 6 months post (post ccm),
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Retrospective | Change in Atrial Fibrillation (AF) Burden | pre ccm | 19.5 average minutes of AF/day |
| Retrospective | Change in Atrial Fibrillation (AF) Burden | post ccm | 10.2 average minutes of AF/day |