Cardiac Resynchronization Therapy, Left Bundle Branch Area Pacing
Conditions
Brief summary
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.
Detailed description
The FORGE CSP Registry is a prospective, multicentre and nationwide, post-approval registry, including consecutive patients with an indication for CRT and in whom implantation of a LBBAP ICD lead is attempted as a first line strategy. The primary objective of this registry is to measure the proportion of patients who achieve effective CRT solely through the use of a LBBAP ICD lead (plus right atrial lead if appropriate). The secondary objectives of this registry are: (1) to assess the feasibility of the LBBAP ICD lead implantation (regarding LBBAP validated electrophysiologic criteria) and the associated learning curve; (2) to evaluate the incidence of implantation of a third lead, namely a left ventricular lead positioned in the coronary sinus, in combination with the LBBAP ICD lead (LOT-CRT); (3) to assess the risk of complications related to the use of the LBBAP ICD lead, including its impact on tricuspid valve function, the risk of lead dislodgement, and other procedure- or device-related complications; (4) to evaluate de cost-effectiveness of CRT using LBBAP ICD lead, compared with conventional CRT; (5) and to compare CRT response in LBBAP ICD lead recipients, versus historical cohort of conventional CRT.
Interventions
None listed
Sponsors
University Hospital, Caen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age \> 18-year-old * indication for CRT according to current ESC/EHRA guidelines * first-line LBBAP ICD lead implantation attempted * national insurance coverage
Exclusion criteria
* pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LBBAP ICD lead CRT efficacy | 0 - 3 Months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LBBAP ICD lead implantation feasibility | Procedural | Incidence of successful LBBAP ICD lead implantation (defined by LBBAP ECG validated criteria) |
| LOT-CRT utilization | Procedural | Incidence of coronary sinus left ventricular lead implantation (in addition to LBBAP ICD lead) |
| Safety of LBBAP ICD lead | 0 - 3 Months | 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) |
| Cost-effectiveness | Procedural | Comparaison of device-associated costs in LBBAP ICD lead recipients and conventional CRT recipients. |
Countries
France
Contacts
CONTACTPierre OLLITRAULT, MD
Outcome results
None listed