Quality of Life in Patients Treated With Leadless Pacemakers

NCT05958836 | Not Yet Recruiting

• 1 other identifier: MicraQL
• Study Type: observational
• Target: 246
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• Health-related quality of life measured by EQ-5D-5L

  The EQ-5D-5L results shall be collected during study follow up visits

  6 Months post implant

• Health-related quality of life measured by NHP (Nottingham Health Profile)

  The NHP results shall be collected during study follow up visits

  6 Months post implant

Study Arms (2)

Micra TPS group

Device: pacemaker

Traditional PM group

Interventions

pacemaker DEVICE

Micra TPS or traditional PM group

Micra TPS group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients are eligible if they meet the indication of a single or dual chamber permanent pacemaker. All subjects should fit the following inclusion criteria and disagree with the exclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: July 25, 2023
• Study Start: July 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share