Quality of Life in Patients Treated With Leadless Pacemakers

Not yet recruiting

• Conditions: Quality of Life; Leadless Micra Transcatheter Pacemaker
• Interventions: Device: pacemaker

• Registration Number: NCT05958836
• Lead Sponsor: Shanghai Zhongshan Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-07
• Study Start: 2023-07
• Study First Submitted: 2023-07-12
• Study First Submitted QC: 2023-07-24
• Last Update Submitted: 2023-07-24
• Study First Posted: 2023-07-25
• Last Update Posted: 2023-07-25
• Primary Completion: 2025-12
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 246

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Micra TPS group	pacemaker	-

Primary Outcome Measures

Name	Time	Method
Health-related quality of life measured by NHP (Nottingham Health Profile)	6 Months post implant	The NHP results shall be collected during study follow up visits
Health-related quality of life measured by EQ-5D-5L	6 Months post implant	The EQ-5D-5L results shall be collected during study follow up visits