Placement Of Cardiac PacemaKer Trial (POCKET)-RCT

NCT02931760 | Unknown

• 1 other identifier: 2016371
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• patient overall satisfaction

  Is there a different in patient overall satisfaction (on a VAS-scale between 0-10) with the pocket between patients with intramuscular placement of a pacemaker pocket and patients with subcutaneous placement at 24 months after implant?

  24 months

Secondary Outcomes (8)

• complications due to pacemaker procedure

  24 months

• pain problems due to pacemaker device

  24 months

• discomfort due to pacemaker device

  24 months

• Patient own judgement of degree of unsightly look due to pacemaker device

  24 months

• movement problems due to device

  24 months

Study Arms (2)

subcutaneous pacemaker

ACTIVE COMPARATOR

The patients who are randomized to receive a subcutaneously implanted pacemaker

Device: subcutaneous pacemaker

intramuscular pacemaker

ACTIVE COMPARATOR

The patients who are randomized to receive an intramuscular implanted pacemaker

Device: intramuscular pacemaker

Interventions

subcutaneous pacemaker DEVICE

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

subcutaneous pacemaker

intramuscular pacemaker DEVICE

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

intramuscular pacemaker

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication of a bradycardia pacemaker (DDDR, VVIR).

You may not qualify if:

• CRTP, CRTD, ICD.
• Very skinny patient deemed as such by implanting physician to clearly benefit from intramuscular implant.

Sponsors & Collaborators

• Region Gävleborg: lead

Study Sites (1)

Region Gavleborg

Gävle, Gävle, 80325, Sweden

RECRUITING

Related Publications (7)

• Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P, Boriani G, Breithardt OA, Cleland J, Deharo JC, Delgado V, Elliott PM, Gorenek B, Israel CW, Leclercq C, Linde C, Mont L, Padeletti L, Sutton R, Vardas PE; ESC Committee for Practice Guidelines (CPG); Zamorano JL, Achenbach S, Baumgartner H, Bax JJ, Bueno H, Dean V, Deaton C, Erol C, Fagard R, Ferrari R, Hasdai D, Hoes AW, Kirchhof P, Knuuti J, Kolh P, Lancellotti P, Linhart A, Nihoyannopoulos P, Piepoli MF, Ponikowski P, Sirnes PA, Tamargo JL, Tendera M, Torbicki A, Wijns W, Windecker S; Document Reviewers; Kirchhof P, Blomstrom-Lundqvist C, Badano LP, Aliyev F, Bansch D, Baumgartner H, Bsata W, Buser P, Charron P, Daubert JC, Dobreanu D, Faerestrand S, Hasdai D, Hoes AW, Le Heuzey JY, Mavrakis H, McDonagh T, Merino JL, Nawar MM, Nielsen JC, Pieske B, Poposka L, Ruschitzka F, Tendera M, Van Gelder IC, Wilson CM. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J. 2013 Aug;34(29):2281-329. doi: 10.1093/eurheartj/eht150. Epub 2013 Jun 24. No abstract available.

  PMID: 23801822 BACKGROUND

• Gadler F, Valzania C, Linde C. Current use of implantable electrical devices in Sweden: data from the Swedish pacemaker and implantable cardioverter-defibrillator registry. Europace. 2015 Jan;17(1):69-77. doi: 10.1093/europace/euu233. Epub 2014 Oct 21.

  PMID: 25336667 BACKGROUND

• Rajappan K. Permanent pacemaker implantation technique: part II. Heart. 2009 Feb;95(4):334-42. doi: 10.1136/hrt.2008.156372. No abstract available.

  PMID: 19176569 BACKGROUND

• Rajappan K. Permanent pacemaker implantation technique: part I: arrhythmias. Heart. 2009 Mar;95(3):259-64. doi: 10.1136/hrt.2007.132753. No abstract available.

  PMID: 19144885 BACKGROUND

• Kirkfeldt RE, Johansen JB, Nohr EA, Jorgensen OD, Nielsen JC. Complications after cardiac implantable electronic device implantations: an analysis of a complete, nationwide cohort in Denmark. Eur Heart J. 2014 May;35(18):1186-94. doi: 10.1093/eurheartj/eht511. Epub 2013 Dec 17.

  PMID: 24347317 BACKGROUND

• Kistler PM, Fynn SP, Mond HG, Eizenberg N. The subpectoral pacemaker implant: it isn't what it seems! Pacing Clin Electrophysiol. 2004 Mar;27(3):361-4. doi: 10.1111/j.1540-8159.2004.00442.x.

  PMID: 15009864 BACKGROUND

• Gold MR, Peters RW, Johnson JW, Shorofsky SR. Complications associated with pectoral implantation of cardioverter defibrillators. World-Wide Jewel Investigators. Pacing Clin Electrophysiol. 1997 Jan;20(1 Pt 2):208-11. doi: 10.1111/j.1540-8159.1997.tb04844.x.

  PMID: 9121991 BACKGROUND

Study Officials

• Per Liv, Ph.D

  Centre for Research and Development Gavleborg/Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter M Magnusson, M.D.

CONTACT

+46 705 089407; peter.magnusson@regionagavleborg.se

Leo Wennstrom, M.D.

CONTACT

+462615400; leo.wennstrom@regiongavleborg.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Cardiologist

Study Record Dates

• First Submitted: October 1, 2016
• First Posted: October 13, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2019
• Last Updated: October 13, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)