Quality of Life in Patients Treated With Leadless Pacemakers

NCT ID: NCT05958836

Last Updated: 2023-07-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 246 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2026-06-30

Brief Summary

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.

Conditions

Leadless Micra Transcatheter Pacemaker; Quality of Life

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Micra TPS group

pacemaker

Intervention Type: DEVICE

Micra TPS or traditional PM group

Traditional PM group

No interventions assigned to this group

Interventions

pacemaker

Micra TPS or traditional PM group

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

MicraQL

Identifier Type: -

Identifier Source: org_study_id