Conduction System Vs Surgical Left Ventricular Epicardial Pacing For Coronary Sinus Lead Failure

Last updated: October 25, 2024
Sponsor: Kansas City Heart Rhythm Research Foundation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Failure

Hyponatremia

Chest Pain

Treatment

Coronary Sinus Lead Revision

Clinical Study ID

NCT06342492
KCHRRF_CS Lead Failure_0025
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 replacedwith transthoracic epicardial lead placement or CSP

  • Underwent Medtronic, Boston Scientific, or Abbott lead placement

Exclusion

Exclusion Criteria:

  • Patients younger than 18 years of age

  • Transthoracic epicardial lead placement or CSP performed as the initial approach orfor other reasons than lead replacement

  • Those for which CRT no longer provides symptom relief or mortality benefit.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Coronary Sinus Lead Revision
Phase:
Study Start date:
November 07, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • Kansas City Heart Rhythm Institute

    Overland Park, Kansas 66211
    United States

    Active - Recruiting

  • Kansas City Heart Rhythm Institute - Roe Clinic

    Overland Park, Kansas 66211
    United States

    Site Not Available

  • Menorah Medical Center

    Overland Park, Kansas 66209
    United States

    Site Not Available

  • Overland Park Regional Medical Center

    Overland Park, Kansas 66215
    United States

    Site Not Available

  • Centerpoint Medical Center

    Independence, Missouri 64057
    United States

    Site Not Available

  • Centerpoint Medical Center Clinic

    Independence, Missouri 64057
    United States

    Site Not Available

  • Research Medical Center

    Kansas City, Missouri 64032
    United States

    Site Not Available

  • Research Medical Center Clinic

    Kansas City, Missouri 64032
    United States

    Site Not Available

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