Quality of Life in Patients Treated With Leadless Pacemakers

Quality of Life Clinical Trial

Official title:

Quality of Life and Clinical Outcomes in Patients Treated With Leadless Micra Transcatheter Pacemakers as Compared With Traditional Transvenous Pacemakers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05958836
• Other study ID #: MicraQL
• Status: Not yet recruiting
• Start date: July 2023
• Est. completion date: June 2026

Study information

• Verified date: July 2023
• Source: Shanghai Zhongshan Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 246
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Quality of Life

Intervention

Device:
• pacemaker
Micra TPS or traditional PM group

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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