Heart Block AV, Heart Failure, Systolic, LBBB, Sinus Node Dysfunction
Conditions
Brief 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.
Detailed 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.
Interventions
PROCEDUREConventional fluoroscopy guided Conduction System Pacing(CSP)
conventional standard approach Conduction System Pacing(CSP) using fluoroscopy
PROCEDUREElectroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP)
Conduction System Pacing(CSP) using electroanatomic mapping system with no or minimal fluoroscopy
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
CSP can be achieved successfully and safely utilizing electro-anatomic mapping (EAM) with the CARTO 3mapping system
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success of achieving CSP | Intra-procedure | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total radiation exposure time during procedure | Intra-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. |
| Procedure-related complications | 30 days post procedure | 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. |
| Need for His Lead revisions | for a period of 6 months post procedure | 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. |
Countries
United States
Outcome results
None listed