INNOVATING FOR ACCESS AND AFFORDABILITY

It is well known that in the United States and other parts of the world, women and people of diverse ethnic and cultural backgrounds are disproportionally impacted by cardiovascular disease and are considerably underrepresented in the clinical trials process.² This limits access to the most advanced treatments and worsens the challenges around health care equity and prevents us from understanding how different groups may respond to different treatments and therapies. Regulatory bodies like the U.S. FDA have developed guidance for sponsors of clinical trials to enroll patient populations that reflect the population needing the treatment or therapy.³ Abbott is doing its part to transform care by intentionally designing access and affordability into our life-changing technologies.⁴ For this study, Abbott has developed some tools and resources designed to make it easier for you to participate in this clinical trial.

Key Inclusion Criteria*

1.     Subject must have at least one of the clinical indications before device implant in adherence with current dual-chamber pacing guidelines

2.     Subject is ≥ 18 years of age or age of legal consent, whichever age is greater

3.     Subject has a life expectancy of at least 1 year

Key Exclusion Criteria*

1.     Subject is currently participating in another clinical investigation that may confound the results of this study as determined by the Sponsor

2.     Subject is pregnant or nursing and those who plan pregnancy during the clinical investigation follow-up period

3.     Subject has a known allergy or hypersensitivity to < 1 mg of dexamethasone sodium phosphate or any blood-or tissue-contacting material listed in the IFU

4.     Subject has an implanted vena cava filter or mechanical tricuspid valve prosthesis

5.     Subject has pre-existing, permanent endocardial pacing or defibrillation leads (does not include lead fragments)

6.     Subject has current implantation of either conventional or subcutaneous implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device

7.     Subject has an implanted leadless cardiac pacemaker (except for an Aveir ventricular LP)

8.     Subject is implanted with an electrically active implantable medical device with stimulation capabilities (such as neurological or cardiac stimulators)**

9.     Subject is unable to read or write

What to Expect if you Participate in the Trial?

Screening

Before you are enrolled, you will assessed to make sure you qualify for this study. Your screening will include:

1. An in-person visit with a heart rhythm specialist (electrophysiologist)

2. An electrocardiogram (EKG)

3. A review of your medical history

Implant

If the screening process shows you are the right candidate for the trial and you agree to participate in the study, you will receive an Aveir DR Leadless Pacemaker System.

Follow-up 

Is this Study Right for Me?

You may be eligible for the Avier DR i2i trial if:

• Your physician has told you that a dual-chamber pacemaker may help your slow or irregular heartbeat
  
• You are 18 years of age or older
  
• You have a life expectancy of at least one year
  
• You understand the nature of the study, are able and willing to comply with the clinical investigation procedures and agree to return to the clinic for all required tests, exams, and follow-up visits
  
• You have been provided with a signed written informed consent on a legal document that is approved by the Institutional Review Board/Ethics Committee