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Trial record 61 of 62 for:    "Sick Sinus Syndrome"

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
Sponsor:
Information provided by (Responsible Party):
Parikshit Sharma, Rush University Medical Center

Tracking Information
First Submitted Date  ICMJE October 31, 2018
First Posted Date  ICMJE April 4, 2019
Last Update Posted Date April 10, 2019
Estimated Study Start Date  ICMJE May 2019
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 8, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
Feasibility of achieving PHBP. [ Time Frame: Intra-procedure ]
Feasibility will be measured by the ability to successfully implant the His Bundle Pacing lead at the desired location.
Change History Complete list of historical versions of study NCT03903107 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fluoroless vs Conventional HBP
Official Title  ICMJE Fluoroless Permanent HIS Bundle Pacing Utilizing Electro-anatomic Mapping Versus Conventional Implantation
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Sinus Node Dysfunction
  • Heart Block AV
  • LBBB
  • Heart Failure, Systolic
Intervention  ICMJE
  • Procedure: Conventional fluoroscopy guided HBP
    conventional standard approach his bundle pacing using fluoroscopy
  • Procedure: Electroanatomic Mapping (fluoroless) guided HBP
    his bundle pacing using electroanatomic mapping system with no or minimal fluoroscopy
Study Arms  ICMJE
  • Placebo Comparator: Conventional His Bundle Pacing
    Patients in this arm will receive permanent his bundle pacing using conventional fluoroscopy technique
    Intervention: Procedure: Conventional fluoroscopy guided HBP
  • 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
    Intervention: Procedure: Electroanatomic Mapping (fluoroless) guided HBP
Publications * Sharma PS, Huang HD, Trohman RG, Naperkowski A, Ellenbogen KA, Vijayaraman P. Low Fluoroscopy Permanent His Bundle Pacing Using Electroanatomic Mapping. Circ Arrhythm Electrophysiol. 2019 Feb;12(2):e006967. doi: 10.1161/CIRCEP.118.006967.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 2, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2021
Estimated Primary Completion Date November 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kelli Jones, RN 3129428707 kelli_jones@rush.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03903107
Other Study ID Numbers  ICMJE 18090701
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Parikshit Sharma, Rush University Medical Center
Study Sponsor  ICMJE Rush University Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rush University Medical Center
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP