Circulatory System Chronotropic Incompetence
Conditions
Interventions
Implant of Ingenio or Advantio pacemaker device
Sponsors
Dr MT Mpe
Retrasol
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants 18 years of age or older Participants suffering from chronotropic incompetence Participants able and willing to sign informed consent Participants qualifying to receive a Boston Scientific Ingenio or Advantio device with the Minute Ventilation , Accelerometer or Blended Sensor (both combined) features Patients who remain in the clinical care of the enrolling physician
Exclusion criteria
Exclusion criteria: Patients whose previous pacemaker had a minute ventilation sensor Patients in whom a symptom-limited exercise protocol is thought to be dangerous because of coronary artery disease or other cardiac disease Uncontrolled arrhythmias (e.g., chronic atrial fibrillation, frequent/persistent atrial fibrillation, ventricular arrhythmias, or patients with ablate and pace whose arrhythmia continues to be uncontrolled) Patients whose medical condition is expected to preclude the use of the protocol-required primary pacing mode Patients whose life expectancy is less than 12-months due to other medical conditions Patients who have or who are indicated for an implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy-defibrillator (CRT-D) Patients who have active chronic leads that are either single-pass VDD, unipolar ventricular and atrial, non-IS-1, and non-3.2mm UNLESS the leads are replaced with bipolar leads that are IS-1/3.2mm compatible Patients who are currently enrolled in another investigational study that would directly impact the treatment or outcome of the current study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To demonstrate the benefit of Minute Ventilation or Blended (minute ventilation in combination with accelerometer) Sensors in participants suffering from Chronotropic Incompetence. | — |
Countries
South Africa
Contacts
Public ContactElsabe de Kock
Public Enquiries
Outcome results
None listed