Peak Plasma Blade in comparison with electro cauterisation during aggregate replacement of implantable cardioverter defibrillators an pacemakers

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00006182

Enrollment

Registered

2014-05-26

Start date

2014-04-29

Completion date

Unknown

Last updated

2026-04-27

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

Conditions

planned aggregate replacement of implantable cardioverter defibrillators I50

Interventions

Group 1: Aggregate replacement operations of implantable cardioverter defibrillators and pacemakers by Peak PlasmaBlade Group 2: Aggregate replacement operations of implantable cardioverter defibrilla

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Planned aggregate replacement of an implanted cardiac defibrillator or pacemaker - Patient age = 18 years - Presence of an oral and written patient informed consent

Exclusion criteria

Exclusion criteria: - Patients with a primary indication for the application of one of the two investigated surgical instruments - Pregnancy - Patients who stand under legal or medical supervision - Participation in another interventional study

Design outcomes

Primary

Measure	Time frame
Surgical preparation duration (from skin incision to aggregate exposure)	—

Secondary

Measure	Time frame
- Total procedure duration (from skin incision to skin suture) - Changes in electrical lead values (pacing threshold, impedance, sensing) - Lead isolation injuries - Wound infections - Aggregate pocket hematoma - Wound healing deficits	—

Countries

Germany

Contacts

Public ContactMartin Huemer

Medizinische Klinik m.S. KardiologieCharité Campus Virchow Klinikum

martin.huemer@charite.de030 450665411

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: May 1, 2026