Feasibility and Outcomes Registry of Lumenless dEfibrillation Leads for Conduction System Pacing (FORGE CSP)

February 6, 2026 updated by: Pierre OLLITRAULT, University Hospital, Caen
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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Caen, France
        • Caen University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive patients with a validated CRT indication for whom the implantation of a LBBAP ICD lead in attempted as a first-line strategy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
0 - 3 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LBBAP ICD lead implantation feasibility
Time Frame: Procedural
Incidence of successful LBBAP ICD lead implantation (defined by LBBAP ECG validated criteria)
Procedural
LOT-CRT utilization
Time Frame: Procedural
Incidence of coronary sinus left ventricular lead implantation (in addition to LBBAP ICD lead)
Procedural
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)
0 - 3 Months
Cost-effectiveness
Time Frame: Procedural
Comparaison of device-associated costs in LBBAP ICD lead recipients and conventional CRT recipients.
Procedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Caen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

February 6, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 12, 2026

Study Record Updates

Last Update Posted (Actual)

February 12, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2026-RYTHMO-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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