Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Conduction System Pacing(CSP) using fluoroscopy | Placebo Comparator | Subjects in this arm will receive Conduction System Pacing(CSP) using conventional fluoroscopy technique. |
|
| Fluoroless Conduction System Pacing(CSP) utilizing EAM with the CARTO 3 mapping system | Experimental | Subjects in this arm will receive Conduction System Pacing(CSP) utilizing electroanatomic mapping system to eliminate or minimize fluoroscopic exposure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional fluoroscopy guided Conduction System Pacing(CSP) | Procedure | conventional standard approach Conduction System Pacing(CSP) using fluoroscopy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30704289 | Result | 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.118.006967. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012804 | Sick Sinus Syndrome |
| D054537 | Atrioventricular Block |
| D054143 | Heart Failure, Systolic |
| ID | Term |
|---|---|
| D001146 | Arrhythmia, Sinus |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
CSP can be achieved successfully and safely utilizing electro-anatomic mapping (EAM) with the CARTO 3mapping system
Not provided
Not provided
Not provided
| Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP) | Procedure | Conduction System Pacing(CSP) using electroanatomic mapping system with no or minimal fluoroscopy |
|
| Intra-procedure |
| 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 |
| 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 |
| D006327 |
| Heart Block |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006333 | Heart Failure |