Heart failure
Conditions
Interventions
Group with 3D pringted heart model:Preoperative 3D printed heart guided CRT implantation
Routine treatment group (control group):Routine treatment
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1: Age = 18 years. 2: Indications for CRT implantation in accordance with current guidelines: patients with a New York Heart Association (NYHA) = Class II, LVEF = 35%, and QRSd = 130 ms after optimal drug therapy 3: or patients with indications for permanent pacemaker implantation, LVEF 40% or high AV block or patients with symptomatic atrial fibrillation with poor ventricular rate control, LVEF 36-40%, and indications for atrioventricular node ablation. Translated with www.DeepL.com/Translator (free version) 4: Voluntary participation in the study and signing of the informed consent form, good compliance, and cooperation in completing follow-up visits.
Exclusion criteria
Exclusion criteria: 1: Patients with previously implanted CRT systems or newly implanted or upgraded to tethered systems. 2: History of serious cardiovascular events (unstable angina, acute myocardial infarction, coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI), etc., cerebral infarction, traumatic brain injury, cerebral hemorrhage, etc.) within the last 3 months. 3: Patients with a history of mechanical right heart valves or transplants 4: Severe hepatic or renal impairment (hepatic or renal impairment: the presence of clinically significant abnormal results in the subject's renal function tests as assessed by the investigator). 5: Involved in other clinical studies currently. 6: Expected survival <1 year. 7: Patients who are pregnant or planning to become pregnant. 8: History of malignant tumors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Procedure time;Fluoroscopy time (number of times);Contrast dose; | — |
Secondary
| Measure | Time frame |
|---|---|
| Left ventricular ejection fraction;Left ventricular end-systolic volume;Left ventricular end-diastolic volume;Left atrial anterior-posterior diameter;New York Heart Association;6-Minute walk test;Minnesota heart failure quality of life scale score; | — |
Countries
China
Contacts
Public ContactPeng Xiaoping
The First Affiliated Hospital of Nanchang University
Outcome results
None listed