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

April 1, 2024 updated by: Kansas City Heart Rhythm Research Foundation
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66209
        • Menorah Medical Center
      • Overland Park, Kansas, United States, 66215
        • Overland Park Regional Medical Center
      • Overland Park, Kansas, United States, 66211
        • Kansas City Heart Rhythm Institute - Roe Clinic
    • Missouri
      • Independence, Missouri, United States, 64057
        • Centerpoint Medical Center
      • Independence, Missouri, United States, 64057
        • Centerpoint Medical Center Clinic
      • Kansas City, Missouri, United States, 64032
        • Research Medical Center Clinic
      • Kansas City, Missouri, United States, 64032
        • Research Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Adults who underwent CS lead revision, comparing epicardial lead placement to CSP in those that had lead failure.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Conduction System Pacing
Subjects who had lead placement via conduction system pacing approach
Other: Coronary Sinus Lead Revision
Coronary Sinus Lead Revision
Epicardial Lead Placement
Subjects who had lead placement via transthoracic, epicardial approach
Other: Coronary Sinus Lead Revision
Coronary Sinus Lead Revision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for 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
Procedure Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Electrocardiography characteristics - QRS Interval
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
Procedure Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kansas City Heart Rhythm Research Foundation

Investigators

  • Principal Investigator: Naga Venkata K. Pothineni, Kansas City Heart Rhythm Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

February 6, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

April 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCHRRF_CS Lead Failure_0025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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