Kansas City Heart Rhythm Institute
Overland Park, Kansas, 66211, United States
Location status: Recruiting
NCT Number: NCT06342492
This a single-center, retrospective, observational study of patients that undergo coronary sinus(CS) lead revision, comparing epicardial lead placement to coronary sinus pacing(CSP) in those that had lead failure.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Overland Park, Kansas, 66211, United States
Location status: Recruiting
Cardiac resynchronization therapy with defibrillator(CRT-D) improves quality of life, functionality, and even mortality for select patients with severe heart failure with reduced ejection fraction (HFrEF). It traditionally consists of three leads placed endovascularly into the right atrium, right ventricle, and left ventricle (LV) [typically placed into the CS], known as biventricular pacing resynchronization (BVP-CRT), respectively, from which electrical stimulation enables improved cardiac synchrony. Nonetheless, the placement of a CRT-D is not without risks. Lead-related complication is high and CRT-D implantation fails in up to 30% of patients due to lead placement alone.
Epicardial lead placement and CSP have been deemed viable alternatives to CRT-D. It has even been shown to be options in patients that fail conventional BVP-CRT. This is primarily due to increased accuracy, decreased complications, and even durability. However, guidelines for decision between a transthoracic approach and CSP is unclear, even more so after lead failure. Instead, this decision is currently individualized to the patient. There is a lack of prospective and head-to-head data between the two, and this study is aimed to compare transthoracic LV epicardial lead placement and CSP in patients with lead failure after BVP-CRT.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Coronary Sinus Lead Revision
Time frame: Procedure Day
Compare the need for lead revision between conduction system pacing (CSP) and transthoracic left ventricular (LV) epicardial pacing approach
Time frame: Procedure Day
Compare electrocardiography characteristics - QRS Interval measured in seconds between conduction system pacing (CSP) and transthoracic left ventricular (LV) epicardial pacing approach
Interested in participating?
Request InfoKansas City Heart Rhythm Research Foundation
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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