To assess the feasibility of implantation of CRT devices via a combined transvenous and epicardial procedure in patients with an unfavourable coronary venous anatomy. In addition, the safety of the procedure will be assessed in preparation for a…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Number of succesful device implantations.
The procedure is considerd succesfol when implantation of a CRT device succeeds
in all study patients through the procedure described above.
Secondary outcome
1. Safety.
The procedure is considerd safe when no procedure related deaths occur and
procedure related complications occur in three patients or less.
2. Conversion to minithoracotomy.
Background summary
At least thirty percent of patients undergoing transvenous implantation of a
device for cardiac resynchronization therapy (CRT) do not respond to therapy.
Possible causes include failure of left ventricular lead placement due to an
inaccessible coronary sinus and suboptimal left ventricular lead position or
dislocation. These problems can be overcome by epicardial implantation of the
left ventricular lead using video-assisted thoracic surgery (VATS).
Study objective
To assess the feasibility of implantation of CRT devices via a combined
transvenous and epicardial procedure in patients with an unfavourable coronary
venous anatomy. In addition, the safety of the procedure will be assessed in
preparation for a larger randomized study.
Study design
Single centre, prospective cohort feasibility study, not placebo controlled.
Intervention
All patients undergo implantation of a CRT device via a combined transvenous
and epicardial approach.
Study burden and risks
CRT implantation already has a class IA indication in the selected study
population. When effective, symptoms and prognosis improve significantly. The
implantation of the right atrial and right ventricular leads will be performed
via the transvenous route according to standard procedure. No additional risks
or benefits accompany this part of the procedure. The left ventricular lead
will be implanted epicardially using VATS through a standardized procedure
already used in 70 patients in which transvenous placement of the left
ventricular lead failed. Benefits are a 100% chance of success of adequate left
ventricular lead placement with a 0% lead failure rate (current status in the
UMCG), reduced radiation exposure, smaller risk of cardiac tamponade, shorter
procedure time, no risk of coronary sinus rupture and reduced need for
re-intervention. Associated burdens are the necessity to undergo general
anesthesia, chest tube drainage for at least a day, a greater need for
postprocedural pain medication and longer hospital stay (a few days). VATS
associated complications include lung trauma, pneumothorax, peri- and
postprocedural bleeding and infection. However, pneumothorax, bleeding and
infection are also complications of transvenous lead placement. Both epicardial
and transvenous lead placement carry a risk of ventricular arrhythmias.
Hanzeplein 1
Groningen 9700RB
NL
Hanzeplein 1
Groningen 9700RB
NL
Listed location countries
Age
Inclusion criteria
1. Left ventricular ejection fraction < 36%.
2. Intraventricular conduction delay >119 ms of >129 ms and presence of left bundle branch block.
3. On optimal medical therapy for heart failure.
4. No sidebranch of the coronary sinus near the posterolateral wall of the left ventricle and/or presence of a Thebesian valve which reduces coronary sinus diameter 50% or more (corresponding to a decrease in cross sectional area of 75% or more).
5. Signed informed consent.
Exclusion criteria
1. Previous intrathoracic surgery
2. Coronary ischemia or recent myocardial infarction (< 6 months)
3. Suspected presence of a non-compliant left lung.
Design
Recruitment
Medical products/devices used
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 | NL46451.042.13 |