Pacing and cardiomyopathy
Conditions
Interventions
The second phase :None
Sponsors
The First People's Hospital of Yunnan Province
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Enrollment Criteria for Phase I of this Study: 1. Aged 18-80 (inclusive) and 80 years old; 2. Implantation of a single-chamber or dual-chamber permanent pacemaker in our hospital in the past. 3. Meet the diagnostic criteria for pacing-mediated cardiomyopathy: (1) Baseline left ventricular ejection fraction (LVEF) >=50%, and LVEF =10% during the postoperative follow-up period; (3) Regardless of baseline LVEF, the absolute value of LVEF decreased by >=10% during the postoperative follow-up period; 4. Willing to participate in this study and have signed an informed consent form. Enrollment criteria for Phase II of this study: 1. Aged 18-80 (inclusive) and 80 years old; 2. Meet the indications for permanent pacemaker implantation; 3. According to the risk prediction score model and pathogenic genes that have been constructed in the first phase of this study, high-risk patients with pacing-mediated cardiomyopathy will be screened in patients who are to be implanted with permanent pacemakers in our hospital; 4. Have decided to implant a permanent cardiac pacemaker, and have signed the informed consent form for surgery and the informed consent form for this study.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for Phase I of this Study: (1) Expected survival < 1 year; (2) Suffering from serious infection, psychiatric and tumor diseases; (3) Women who are pregnant, planning to become pregnant, or breastfeeding; (4) Have a history of heart transplantation; (5) The patient participated in other clinical studies at the same time, which may confound the results of this study; (6) Other reasons that the investigator considers unsuitable to participate in this study. Exclusion Criteria for Phase II of this Study: (1) Those who have an expected survival of < 1 year or are unable to complete the follow-up as planned due to other reasons; (2) Suffering from serious infection, psychiatric and tumor diseases; (3) Women who are pregnant, planning to become pregnant, or breastfeeding; (4) Have a history of heart transplantation; (5) The patient participated in other clinical studies at the same time, which may confound the results of this study; (6) The patient had a history of unstable angina, acute myocardial infarction, coronary artery bypass surgery and coronary stent implantation within 3 months; (7) The patient has undergone any heart valve surgery or any other cardiac surgery, such as TAVI and ventricular septal myocardial resection and ablation within 3 months; (8) ICD, CRT or CRTD with exact indications, unless the doctor and patient fully communicate and decide to choose a single-chamber or dual-chamber pacemaker, and have signed the informed consent form; (9) Pacemaker replacement, pacemaker upgrade, pacemaker pouch infection and re-implantation; (10) Patients and their families resolutely choose traditional pacing or physiological pacing, and are unwilling to carry out randomization; (11) Other reasons that the investigator considers unsuitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pacemaker follow-up data;Gene sequencing; | — |
Countries
China
Contacts
Public ContactFan Jie
The First People's Hospital of Yunnan Province
Outcome results
None listed