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NCT Number: NCT07406737

Feasibility and Outcomes Registry of Lumenless dEfibrillation Leads for Conduction System Pacing

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.

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Key information

Conditions

Cardiac Resynchronization Therapy Left Bundle Branch Area Pacing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Caen University Hospital

Caen, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. LBBAP ICD lead CRT efficacy

    Time frame: 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 outcomes

  1. LBBAP ICD lead implantation feasibility

    Time frame: Procedural

    Incidence of successful LBBAP ICD lead implantation (defined by LBBAP ECG validated criteria)

  2. LOT-CRT utilization

    Time frame: Procedural

    Incidence of coronary sinus left ventricular lead implantation (in addition to LBBAP ICD lead)

  3. Safety of LBBAP ICD lead

    Time frame: 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)

  4. Cost-effectiveness

    Time frame: Procedural

    Comparaison of device-associated costs in LBBAP ICD lead recipients and conventional CRT recipients.

Study contacts

Contact information is provided by the study sponsor or research team.

Pierre OLLITRAULT, MD

CONTACT

[email protected]

+330231063106

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: FORGE CSP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 12, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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