Feasibility and Outcomes Registry of Lumenless dEfibrillation Leads for Conduction System Pacing
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Caen
About this trial
The recent development and market introduction of small diameter implantable defibrillation leads able to deliver left bundle branch area pacing (LBBAP) has opened the possibility of achieving cardiac resynchronization therapy (CRT) using a single- or dual-chamber implantable-cardioverter defibrillator (ICD). This approach may reduce the number of intracardiac leads required and, consequently, has the potential to lower both procedural and long-term complication rates. However, the integration of these leads into currently recommended CRT strategies remains hypothetical. The FORGE CSP registry will prospectively enroll patients with an indication for CRT in whom implantation of a LBBAP ICD lead is attempted.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age > 18-year-old
indication for CRT according to current ESC/EHRA guidelines
first-line LBBAP ICD lead implantation attempted
national insurance coverage
Disqualifiers
pregnancy
Trial population
Consecutive patients with a validated CRT indication for whom the implantation of a LBBAP ICD lead in attempted as a first-line strategy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
LBBAP ICD lead CRT efficacy
Proportion of patients with an effective CRT (defined by LBBAP validated ECG criteria) using solely the LBBAP ICD lead (plus right atrial lead if appropriate).
Time frame
0 - 3 MonthsSecondary outcomes
1
LBBAP ICD lead implantation feasibility
Incidence of successful LBBAP ICD lead implantation (defined by LBBAP ECG validated criteria)
Time frame
Procedural2
LOT-CRT utilization
Incidence of coronary sinus left ventricular lead implantation (in addition to LBBAP ICD lead)
Time frame
Procedural3
Safety of LBBAP ICD lead
Incidence of ICD lead micro or macro-dislodgment Incidence of de novo tricuspid regurgitation (grade \> or = 3) Incidence of loss of CRT (based on LBBAP validated ECG criteria)
Time frame
0 - 3 Months4
Cost-effectiveness
Comparaison of device-associated costs in LBBAP ICD lead recipients and conventional CRT recipients.
Time frame
ProceduralSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: