Quality of Life in Patients Treated With Leadless Pacemakers

Fudan University

Status: Not yet enrolling

Conditions: Quality of Life; Leadless Micra Transcatheter Pacemaker

Treatments: Device: pacemaker

Study type: Observational

Funder types: Other

Identifiers

NCT05958836

MicraQL

Details and patient eligibility

About

The study aims to carry out a domestic multi-center, prospective, non-randomized, non-blinded post-approval study to assess health-related QoL between Micra TPS and conventional PM implantation. Meanwhile, pocket and leads related complications would also be evaluated between these two strategies.

Enrollment: 246 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• With an age arranged from 18 to 80 years old;
• Conforming to indication of a pacemaker implantation;
• Life expectancy>1 year;
• Normal cardiac function with preserved LVEF;
• Adequate self-care ability or self-help skills before pacemaker implantation;
• Mentally healthy so as to participate in the quality-of-life assessments;
• Willing to participate in study through consent and willing to undergo study specific required procedures with expectancy of geographically stable for follow up duration.

Exclusion criteria

• Subject with indication for ICD/ CRT-P/CRT-D;
• Subject with persistent symptomatic sinus bradycardia;
• Subject has an existing or prior pacemaker, ICD or CRT device implant;
• Subject has unstable angina pectoris or has an acute myocardial infarction (AMI) in the 30 days prior to eligibility assessment;
• Subjects with a mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (LVAD);
• Subjects with a life expectancy of less than 12-months;
• Subjects with medical condition which precludes patient from participation in the opinion of the investigator, such as arthritis, lung disease or previous stroke, renal dysfunction, recent major surgery within six months, clinically overt congestive heart failure;
• Pregnant women or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth regulation method or abstinence;
• Psychological disorders unable to participate in the quality-of-life assessments.

Trial design

246 participants in 2 patient groups

Micra TPS group

Treatment:

Device: pacemaker

Traditional PM group