Fluoroless vs Conventional HBP
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|ClinicalTrials.gov Identifier: NCT03903107|
Recruitment Status : Not yet recruiting
First Posted : April 4, 2019
Last Update Posted : April 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sinus Node Dysfunction Heart Block AV LBBB Heart Failure, Systolic||Procedure: Conventional fluoroscopy guided HBP Procedure: Electroanatomic Mapping (fluoroless) guided HBP||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||PHBP can be achieved successfully and safely utilizing electro-anatomic mapping (EAM) with the CARTO 3mapping system|
|Official Title:||Fluoroless Permanent HIS Bundle Pacing Utilizing Electro-anatomic Mapping Versus Conventional Implantation|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||May 2021|
Placebo Comparator: Conventional His Bundle Pacing
Patients in this arm will receive permanent his bundle pacing using conventional fluoroscopy technique
Procedure: Conventional fluoroscopy guided HBP
conventional standard approach his bundle pacing using fluoroscopy
Experimental: Fluoroless His Bundle Pacing
Patients in this arm will receive permanent his bundle pacing utilizing electroanatomic mapping system to eliminate or minimize fluoroscopic exposure
Procedure: Electroanatomic Mapping (fluoroless) guided HBP
his bundle pacing using electroanatomic mapping system with no or minimal fluoroscopy
- Success of achieving PHBP. [ Time Frame: Intra-procedure ]Success will be measured by the ability to successfully implant the His Bundle Pacing lead at the His Bundle location and capture the His Bundle in a selective or non-selective fashion as described previously.
- Total radiation exposure time during procedure [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903107
|Contact: Kelli Jones, RNfirstname.lastname@example.org|