The Fluoroless-CSP Trial Using Electroanatomic Mapping

Rush

Status: Completed

Conditions: LBBB; Heart Failure, Systolic; Heart Block AV; Sinus Node Dysfunction

Treatments: Procedure: Conventional fluoroscopy guided Conduction System Pacing(CSP); Procedure: Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP)

Study type: Interventional

Funder types: Other

Identifiers

NCT03903107

18090701

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups, including a placebo group

Conventional Conduction System Pacing(CSP) using fluoroscopy

Placebo Comparator group

Description:

Subjects in this arm will receive Conduction System Pacing(CSP) using conventional fluoroscopy technique.

Treatment:

Procedure: Conventional fluoroscopy guided Conduction System Pacing(CSP)

Fluoroless Conduction System Pacing(CSP) utilizing EAM with the CARTO 3 mapping system

Experimental group

Description:

Subjects in this arm will receive Conduction System Pacing(CSP) utilizing electroanatomic mapping system to eliminate or minimize fluoroscopic exposure.

Treatment:

Procedure: Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP)