Clincosm LogoSign in Get a demo

Quality of Life in Patients Treated With Leadless Pacemakers

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05958836
Collaborator
(none)
246
Enrollment
35
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: pacemaker

Study Design

Study Type:
Observational
Anticipated Enrollment :
246 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Quality of Life and Clinical Outcomes in Patients Treated With Leadless Micra Transcatheter Pacemakers as Compared With Traditional Transvenous Pacemakers
Anticipated Study Start Date :
Jul 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Jun 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Micra TPS group

Device: pacemaker
Micra TPS or traditional PM group
Traditional PM group

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shanghai Zhongshan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT05958836
Other Study ID Numbers:
  • MicraQL
First Posted:
Jul 25, 2023
Last Update Posted:
Jul 25, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 25, 2023