Atrial Fibrillation (AF), AV Block, Bradycardia Sinus
Conditions
Brief summary
The goal of this observational study is to assess inter-/intra- ventricular synchrony and ECG characteristics in relation to Micra tip location. The secondary objective is (1) to identify an optimal Micra pacing location to improve LV function, (2) to investigate the correlation between Micra tip location and tricuspid regurgitation, and (3) to investigate whether Micra location would impact AV synchrony. Patients with pacing indications who plan to receive Micra AV implantation will be recruited.
Interventions
OTHERObservational
It is a observational study and patients with pacing indications who plan to receive Micra AV implantation will be recruited. No intervention procedure will be performed.
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged above 18 years old * Patients who are willing to provide Informed Consent * Patients with Class I or II indications who plan to receive a leadless pacemaker, including SSS, AVB, AF with bradycardia, etc. * Patients who plan to conduct a cardiac CT scan after implantation
Exclusion criteria
* Patients with lead retention * Patients had heart valve replacement * Patients diagnosed with ischemic heart diseases * Patients who are allergic to or refuse to use contrast in CT scans * Patients who are pregnant or have a plan for pregnancy during the study * Patients with medical conditions that would limit study participation * Patients already enrolled in another clinical trial which would impact participation of this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of ECG characteristics in relation to Micra tip location | Within 6 months after the surgery. | Patients' ECG will be measured to see whether there is difference in ECG characteristics between Micra tip locations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac functional changes | Within 6 months after the surgery. | LVEF, RV length and quantity of tricuspid regurgitation will be measured. |
| To investigate whether Micra location would impact AV synchrony | Within 6 months after the surgery. | Percentage of AV synchrony will be measured. |
Countries
China
Outcome results
None listed