The objective of the pilotstudy is feasibility and safety.
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Success of the transseptal puncture (yes/no), duration of this part of the
procedure, and possible complications.
Secondary outcome
Technical issues that may have to be improved.
Background summary
This pilotstudy is intended to demonstrate feasibility of the new flexible
puncturewire. In animal studies, this wire functioned perfectly well without
any problems despite the fact the cardiologists had little experience with the
anatomy of the pig that differs from humans. Production of the wire in the UMC
Utrecht is standardized and destructive tests before and after ethylene oxide
sterilization have shown that the connection of the tiny needle at the distal
end of a standard guidewire is sufficiently strong. If the pilotstudy runs
smoothly then we will apply for a larger prospective randomized study were we
will compare the new and old method.
Study objective
The objective of the pilotstudy is feasibility and safety.
Study design
In 10 patients, we the feasibility and safety of a new flexible transseptal
puncturewire will be investigated.
Intervention
The intervention is a slight modification of the present technique of
transseptal puncture. Instead of a long stiff needle we will use a flexible
guidewire with a tiny needle mounted on its distal end.
Study burden and risks
The burden for the participating patients is absent or minimal. We expect that
the transseptal puncture procedure will lead to less complications and go
faster.
Heidelberglaan 100
3584 CX
Nederland
Heidelberglaan 100
3584 CX
Nederland
Listed location countries
Age
Inclusion criteria
All patients that have to undergo a transseptal puncture for catheter ablation of atrial fibrillation or of an accessory left sided atrio-ventricular connection.
Exclusion criteria
Patients who have undergone an earlier transseptal puncture.
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 | NL22240.041.08 |