Pacemaker Ddd Clinical Trial
— POCKET-RCTOfficial title:
Placement Of Cardiac PacemaKer Trial (POCKET)-RCT
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)
Status | Recruiting |
Enrollment | 200 |
Est. completion date | June 2019 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Indication of a bradycardia pacemaker (DDDR, VVIR). Exclusion Criteria: - CRTP, CRTD, ICD. - Very skinny patient deemed as such by implanting physician to clearly benefit from intramuscular implant. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Region Gavleborg | Gävle |
Lead Sponsor | Collaborator |
---|---|
Region Gävleborg |
Sweden,
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, Bänsch 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. — View Citation
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. — View Citation
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. — View Citation
Kirkfeldt RE, Johansen JB, Nohr EA, Jørgensen 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. — View Citation
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. — View Citation
Rajappan K. Permanent pacemaker implantation technique: part I: arrhythmias. Heart. 2009 Mar;95(3):259-64. doi: 10.1136/hrt.2007.132753. — View Citation
Rajappan K. Permanent pacemaker implantation technique: part II. Heart. 2009 Feb;95(4):334-42. doi: 10.1136/hrt.2008.156372. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | complications due to pacemaker procedure | Complications (revision of pocket, dislodgement, hematoma requiring surgery, infection (local/systemic). Measurement: number of each event (n) | 24 months | No |
Secondary | pain problems due to pacemaker device | Patient reported pain at 1, 12 and 24 months on a VAS-scale 0-10. | 24 months | No |
Secondary | discomfort due to pacemaker device | Patient reported discomfort at 1, 12, 24 months on a VAS-scale 0-10. | 24 months | No |
Secondary | Patient own judgement of degree of unsightly look due to pacemaker device | Patient reported satisfaction at 1, 12, 24 months on a VAS-scale 0-10. | 24 months | No |
Secondary | movement problems due to device | Patient reported satisfaction at 1, 12, 24 months on a VAS-scale 0-10. | 24 months | No |
Secondary | sleep problems due to device | Patient reported satisfaction at 1, 12, 24 months on a VAS-scale 0-10. | 24 months | No |
Secondary | Pacemaker nurse judgement of unsightly look of the pacemaker pocket | Pacemaker nurse judgement of unsightly look of the pacemaker pocket (month 1, 12, and 24) on a VAS-scale 0-10. | 24 months | No |
Secondary | Picture of pocket | Picture of pocket (1, 12, 24 months) judged by an experienced implanting physician who is blinded to the group allocation and has not operated on the patient on a VAS-scale 0-10. | 24 months | No |
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