Primarily, this study aims to investigate (i) the feasibility and safety of a novel temporary epicardial pacing wire placement using two unipolar pacing electrodes embedded in a gelatin sponge and (ii) the stability of electrical performance of the…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. feasibility and ease of novel implant technique (feasibility assessment
based on "failure rate" (i.e., lead dislodgement)); 2. acute and chronic safety
of implant technique; 3. electrical performance of the new leads; 4. force
needed to extract the lead out of pace patch; 5. complications upon withdrawal
of the lead.
Secondary outcome
NA
Background summary
Temporary epicardial leads are often placed after cardiac surgery for treatment
of arrhythmia*s. Usually, these leads are implanted for several days up to a
week in the postoperative course. Epicardial leads are usually placed by
stabbing through the myocardium. Pacing leads may contain a coil at the
electrode end to secure the lead and prevent accidental dislodgement out of the
myocardium. Although used commonly, temporary pacing leads are associated with
complications. At implant, bleeding may occur due to the needle stabbing or the
presence of a coil at the electrode tip. This, in turn, may require additional
sutures to stop bleeding. In addition, extraction of the lead in the
postoperative course may cause disruption of coronary anastomoses, atrial and
ventricular lacerations, resulting in hemorrhage and cardiac tamponade. Other
complications include arrhythmia*s or migration of retained wire.
Study objective
Primarily, this study aims to investigate (i) the feasibility and safety of a
novel temporary epicardial pacing wire placement using two unipolar pacing
electrodes embedded in a gelatin sponge and (ii) the stability of electrical
performance of the pace patch, both in comparison to conventional leads.
Complications upon lead extraction (bleeding) serves as a secondary objective.
Study design
Interventional study without control group.
Intervention
Novel temporary pacing lead is placed with conventional back-up lead.
Study burden and risks
Patients with need for postoperative pacing may be the first ones to benefit
from this innovation in the future. The technique may enable easier and less
invasive lead placement and extraction, which may lead to less (bleeding)
complications. Patients receive standard treatment. The patch in which the lead
is embedded is biodegradable and already used in the field of cardiac surgery
(used for hemostasis). We investigated in animal studies that novel lead
placement does not carry surplus risk over conventional treatment. For safety
reasons, a conventional back-up lead is placed. Hereby, we guarantee that
patients can be paced under all circumstances, when necessary.
P. Debyelaan 25
6229 HX Maastricht
Nederland
P. Debyelaan 25
6229 HX Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
All will-competent patients of either sex and above the age of 18 undergoing open chest surgery for the first time in their life for coronary artery bypass grafting (CABG) and/or heart valve surgery are potential candidates for this study.
Exclusion criteria
Exclusion criteria include will-incompetency, age below 18, and prior cardiac surgery.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL25905.068.08 |