Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
194 participants
INTERVENTIONAL
2022-12-12
2024-10-08
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.
BIOTRONIK Conduction System Pacing With the Solia Lead - Solia CSP S
NCT06540079
BIO|MASTER.CSP Study
NCT06620237
Pacing Characteristics of a Conventional Bipolar
NCT06011252
BIO|CONCEPT.Amvia Study
NCT05610176
Safety and Performances of the LINEA Cardiac Pacing Lead Optimized for the Implantation in Interventricular Septum
NCT07342608
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Solia S LBB lead
Solia S lead
The Solia S pacing lead will be implanted in the LBB area for patients who meet all inclusion/exclusion criteria and give written informed consent.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Solia S lead
The Solia S pacing lead will be implanted in the LBB area for patients who meet all inclusion/exclusion criteria and give written informed consent.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patient has an implant planned to utilize left bundle branch area pacing within 30 days of consent
* Patient is able to understand the nature of the study and provide written informed consent
* Patient is available for follow-up visits on a regular basis for the expected duration of follow-up
* Patient accepts Home Monitoring® concept
* Patient age is greater than or equal to 18 years at time of consent
Exclusion Criteria
* Patient is currently implanted with a pacemaker or Implantable Cardioverter-Defibrillator (ICD) device
* Patient has had a previous unsuccessful attempt to place a lead in the LBB area
* Patient has planned cardiac surgical procedures or interventional measures within 3 months after implant
* Patient is expected to receive a heart transplant within 12 months
* Patient life expectancy less than 12 months
* Patient has the presence of another life-threatening, underlying illness separate from their cardiac disorder
* Patient reports pregnancy at the time of enrollment
* Patient is enrolled in any other investigational cardiac clinical study during the course of the study
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Biotronik, Inc.
INDUSTRY
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.
Banner - University Medical Center Phoenix
Phoenix, Arizona, United States
Cardiology Associates Medical Group
Ventura, California, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Sarasota Memorial Health Care System
Sarasota, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Cardiology Associates
Tupelo, Mississippi, United States
NYU Langone Health
New York, New York, United States
Weill Cornell Medicine
New York, New York, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Cardiology Consultants of Philadelphia
Philadelphia, Pennsylvania, United States
Geisinger
Wilkes-Barre, Pennsylvania, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol: Protocol Pages 1-48
Document Type: Study Protocol: Protocol Pages 49-81
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
G210349
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.