Quality of Life in Patients Treated With Leadless Pacemakers

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Leadless Micra Transcatheter Pacemaker
• Intervention / Treatment: Device: pacemaker

• Study Type: Observational
• Enrollment (Estimated): 246

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Micra TPS group	Device: pacemaker; Micra TPS or traditional PM group
Traditional PM group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: July 12, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): July 25, 2023

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: MicraQL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No