Clinical trial NCT06342492: Conduction System Vs Surgical Left Ventricular Epicardial Pacing For Coronary Sinus Lead Failure
Official title: Conduction System Vs Surgical Left Ventricular Epicardial Pacing For Coronary Sinus Lead Failure
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Failure With Reduced Ejection Fraction
Lead sponsor: Kansas City Heart Rhythm Research Foundation
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults who underwent CS lead revision, comparing epicardial lead placement to CSP in those that had lead failure.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All patients older than 18 years of age
* Patients with HFrEF that underwent BVP-CRT
* Experienced CS lead failure, whether initial or recurrent, subsequently replaced with transthoracic epicardial lead placement or CSP
* Underwent Medtronic, Boston Scientific, or Abbott lead placement

Exclusion Criteria:

* Patients younger than 18 years of age
* Transthoracic epicardial lead placement or CSP performed as the initial approach or for other reasons than lead replacement
* Those for which CRT no longer provides symptom relief or mortality benefit.

Primary outcomes:
measure: Need for lead revision
timeFrame: Procedure Day
Secondary outcomes:
measure: Electrocardiography characteristics - QRS Interval
timeFrame: Procedure Day
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Kansas City Heart Rhythm Institute
state: Kansas
Study officials:
affiliation: Kansas City Heart Rhythm Institute
name: Naga Venkata K. Pothineni
role: PRINCIPAL_INVESTIGATOR
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