A Clinical Study Evaluating a Novel Leaf-Spring Pocket Compression Device

A Multicenter, Exploratory, Open-Label, Randomized Controlled Trial Comparing the Clinical Effects of a Leaf-Spring Pocket Compressor and Conventional Compression Bandaging After Transvenous Pacemaker Implantation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs042250188

Enrollment

440

Registered

2026-02-26

Start date

2026-02-26

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Sick sinus syndrome 2. Advanced atrioventricular block 3. Bradycardic atrial fibrillation pacemaker implantation, pocket hematoma

Interventions

In this study, postoperative pocket compression methods after pacemaker implantation will be compared between a leaf-spring pocket compression device and a standard compression bandage. In the interve

Leaf-spring pocket compression device, Compression bandage

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria will be eligible: 1. Scheduled to undergo de novo implantation of a single-chamber or dual-chamber transvenous pacemaker. 2. Planned creation of a left subclavian pacemaker pocket. 3. Aged 18 years or older at the time of consent and capable of providing written informed consent personally.

Exclusion criteria

Exclusion criteria: Patients who meet any of the following criteria will be excluded: 1. Known allergy to adhesive tapes or polyurethane, or markedly fragile skin. 2. Body weight >=90 kg or <40 kg. 3. Severe kyphosis. 4. Difficulty in temporarily discontinuing preoperative antiplatelet or anticoagulant therapy, or current treatment with warfarin. 5. Severe dementia. 6. Pregnancy. 7. Judged by the principal investigator or sub-investigator to be unsuitable for participation in this study.

Design outcomes

Primary

Measure	Time frame
Clinically significant pocket hematoma	—

Secondary

Measure	Time frame
1. Clinically significant skin injury 2. Early discontinuation of the assigned compression method 3. Analgesic use within 24 hours after surgery 4. Device or bandage malfunction requiring correction 5. Patient satisfaction score	—

Contacts

Public ContactAkinori Sairaku

NHO Higashihiroshima Medical Center

rjrgw059@ybb.ne.jp+81-82-423-2176

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026