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Fluoroless vs Conventional HBP

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ClinicalTrials.gov Identifier: NCT03903107
Recruitment Status : Enrolling by invitation
First Posted : April 4, 2019
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Parikshit Sharma, Rush University Medical Center

Study Description
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Brief Summary:
The goal of this study is to assess the feasibility, accuracy and safety of performing fluoroless (or low fluoroscopy) permanent His Bundle 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 permanent His Bundle Pacing (HBP) Implants.

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

Detailed Description:
The goal of this study is to assess the feasibility, accuracy and safety of performing fluoroless (or low fluoroscopy) permanent His Bundle 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 permanent His Bundle Pacing (HBP) Implants.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: PHBP can be achieved successfully and safely utilizing electro-anatomic mapping (EAM) with the CARTO 3mapping system
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Fluoroless Permanent HIS Bundle Pacing Utilizing Electro-anatomic Mapping Versus Conventional Implantation
Actual Study Start Date : October 26, 2020
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : February 2022

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903107


Locations
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United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
Rush University Medical Center
More Information
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Publications of Results:

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Responsible Party: Parikshit Sharma, Dr. Parikshit S Sharma, Assistant Professor of Medicine, Director of Electrophysiology Laboratory, Division of Cardiology, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03903107    
Other Study ID Numbers: 18090701
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Heart Failure, Systolic
Heart Block
Sick Sinus Syndrome
Heart Failure
Heart Diseases
 Cardiovascular Diseases
Arrhythmias, Cardiac
Cardiac Conduction System Disease
Pathologic Processes
Arrhythmia, Sinus