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Placement Of Cardiac PacemaKer Trial (POCKET)-RCT

NCT02931760 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2016-10-13

No results posted yet for this study

Summary

Aim: To compare patient satisfaction with intramuscular placement of a pacemaker pocket to subcutaneous placement.

Patients will be randomized (approximately half i each group) to receive the pacemaker device either subcutaneously (current practise) or intramuscular)

Conditions

  • Pacemaker Ddd

Interventions

DEVICE

subcutaneous pacemaker

During implant of a pacemaker the device is either implanted subcutaneously or intramuscular

DEVICE

intramuscular pacemaker

During implant of a pacemaker the device is either implanted subcutaneously or intramuscular

Sponsors & Collaborators

  • Region Gävleborg

    lead OTHER

Principal Investigators

  • Per Liv, Ph.D · Centre for Research and Development Gavleborg/Uppsala University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2017-12-31
Completion
2019-06-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02931760 on ClinicalTrials.gov