Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
2 participants
INTERVENTIONAL
2020-10-26
2024-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
cArdiac Non Invasive MApping in resynchronizaTION
NCT04347109
Safety and Effectiveness of Left Bundle Branch Area Pacing Versus Conventional Cardiac Resynchronization Therapy in Heart Failure
NCT07069738
Monitoring Pulmonary Artery Pressure by Implantable Device Responding to Ultrasonic Signal
NCT00604903
Characterizing Outcomes and Real-World Experience of Cardiac Physiologic Pacing (The CORE-CPP Study)
NCT06606288
Safety and Performance Evaluation of a New Catheter Range for Lead Implantation At Interventricular Septum
NCT06453850
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Conventional Conduction System Pacing(CSP) using fluoroscopy
Subjects in this arm will receive Conduction System Pacing(CSP) using conventional fluoroscopy technique.
Conventional fluoroscopy guided Conduction System Pacing(CSP)
conventional standard approach Conduction System Pacing(CSP) using fluoroscopy
Fluoroless Conduction System Pacing(CSP) utilizing EAM with the CARTO 3 mapping system
Subjects in this arm will receive Conduction System Pacing(CSP) utilizing electroanatomic mapping system to eliminate or minimize fluoroscopic exposure.
Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP)
Conduction System Pacing(CSP) using electroanatomic mapping system with no or minimal fluoroscopy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Conventional fluoroscopy guided Conduction System Pacing(CSP)
conventional standard approach Conduction System Pacing(CSP) using fluoroscopy
Electroanatomic Mapping (Fluoroless) guided Conduction System Pacing(CSP)
Conduction System Pacing(CSP) using electroanatomic mapping system with no or minimal fluoroscopy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Indication for Permanent Pacemaker implantation or implantation of Cardiac Resynchronization Therapy Device
Exclusion Criteria
* Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity
* Pregnancy
* Difficulty with follow-up
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rush University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Rush University Medical Center
Chicago, Illinois, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
18090701
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.