The Fluoroless-CSP Trial Using Electroanatomic Mapping

Heart Failure, Systolic Clinical Trial

Official title:

Fluoroless Conduction System Pacing Utilizing Electro-Anatomic Mapping Versus Conventional Implantation: The Fluoroless- CSP Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03903107
• Other study ID #: 18090701
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 26, 2020
• Est. completion date: September 2024

Study information

• Verified date: July 2023
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to assess the feasibility, accuracy and safety of performing fluoroless (or low fluoro) conduction system pacing utilizing electro-anatomic mapping (EAM) with the CARTO 3 mapping system (Biosense Webster Inc, Irvine, CA) in comparison to a group of patients undergoing conventional conduction system pacing (CSP) Implants.

Description:

The goal of this study is to assess the feasibility, accuracy and safety of performing fluoroless (or low fluoro) conduction system pacing utilizing electro-anatomic mapping (EAM) with the CARTO 3 mapping system (Biosense Webster Inc, Irvine, CA) in comparison to a group of patients undergoing conventional conduction system pacing (CSP) Implants.

In this study, we plan to randomize patients to fluoroscopy guided CSP vs 3D mapping guided CSP implants with low/zero fluoroscopy. The study with assess if 3D EAM guided implants can be performed successfully and without any significant increase in device implant related complications.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Indication for Permanent Pacemaker implantation or implantation of Cardiac Resynchronization Therapy Device

Exclusion Criteria:

• Existing cardiac device including Pacemaker or Cardiac Resynchronization Therapy device

• Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity

• Pregnancy

• Difficulty with follow-up

Related Conditions & MeSH terms

• Heart Block
• Heart Block AV
• Heart Failure, Systolic
• LBBB
• Sick Sinus Syndrome
• Sinus Node Dysfunction

Intervention

Procedure:
• Conventional fluoroscopy guided Conduction System Pacing(CSP)
conventional standard approach Conduction System Pacing(CSP) using fluoroscopy
• Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP)
Conduction System Pacing(CSP) using electroanatomic mapping system with no or minimal fluoroscopy

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sharma PS, Huang HD, Trohman RG, Naperkowski A, Ellenbogen KA, Vijayaraman P. Low Fluoroscopy Permanent His Bundle Pacing Using Electroanatomic Mapping: A Feasibility Study. Circ Arrhythm Electrophysiol. 2019 Feb;12(2):e006967. doi: 10.1161/CIRCEP.118.006 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success of achieving CSP	Feasibility of achieving a successful CSP implant at the His Bundle or Left Bundle branch with low or zero Fluoroscopy. This will result in low to no fluoroscopy exposure for both the subject and the operator, as well as shorter procedure times.This will be documented during procedure.	Intra-procedure
Secondary	Total radiation exposure time during procedure	Total radiation exposure during procedure time will be documented at the total time the patient is exposed to fluoroscopy during the procedure. This will will be tracked and documented as total fluoroscopy duration, His lead Fluoroscopy duration and DAP. The total amounts of procedural fluoroscopy exposure will be compared between the two treatment arms.	Intra-procedure
Secondary	Procedure-related complications	The study team will review medical history of enrolled subjects for any adverse event experienced post-procedurally. All adverse events will be reviewed by PI for determination as to whether "procedure-related" or not.	30 days post procedure
Secondary	Need for His Lead revisions	The study team will track the device follow-up data for a duration of 3 months post device implant. Any patients with > 2V increase in His Lead capture threshold from baseline and need for ventricular pacing will undergo a lead revision.	for a period of 6 months post procedure