Bradyarrhythmia
Conditions
Interventions
Optimised implantation process group:Optimisation of the implantation process
Conventional implantation process group:Routine implantation process
Sponsors
Shanghai Chest Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients with indications for leadless pacemaker implantation 2. Age>=18 years 3. Patients who voluntarily participate in this trial and sign the informed consent form
Exclusion criteria
Exclusion criteria: 1. Has a tricuspid mechanical valve; 2. Has inferior vena cava filter; 3. There are transvenous pacing leads in the heart chamber; 4. Patients with severe cardiomyopathy and valvular disease 5. Patients with contrast agent allergy and other patients who are not suitable for implantation of leadless pacemakers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A combination of adequate capture threshold and sensing amplitude at 6 months;Volume of contrast agent used during procedure (ml); | — |
Secondary
| Measure | Time frame |
|---|---|
| A combination of adequate capture threshold and sensing amplitude at 6 months for different pacing sites;Procedural duration;Fluoroscopy duration;Device-related serious adverse events; | — |
Countries
China
Contacts
Public ContactLi Ruogu
Shanghai Chest Hospital
Outcome results
None listed