NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	1. Sick sinus syndrome 2. Advanced atrioventricular block 3. Bradycardic atrial fibrillation
Date of first enrollment	26/02/2026
Target sample size	440
Countries of recruitment
Study type	Interventional
Intervention(s)	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 intervention group, the leaf-spring device is applied directly over the pocket in an appropriate position and fixed to the chest wall to provide localized compression. In the control group, a gauze bolster is placed over the pocket, and the conventional compression bandage using elastic adhesive tape is applied to the anterior chest. In both groups, compression is initiated within 15 minutes after pocket closure, maintained for 24 hours in principle, and monitored for hematoma, skin injury, pain, and device or bandage malfunction at 8-hour intervals.

Outcome(s)

Primary Outcome	Clinically significant pocket hematoma
Secondary Outcome	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

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Both
Include 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.
Exclude 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.