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NCT Number: NCT06342492

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

Location status: Recruiting

Location contact

Donita Atkins

CONTACT

[email protected]

816-651-1969

Naga Venkata K. Pothineni, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Coronary Sinus Lead Revision

Other

Coronary Sinus Lead Revision

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Donita Atkins

CONTACT

[email protected]

816-651-1969

Sponsors and collaborators

Lead sponsor

Kansas City Heart Rhythm Research Foundation

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 2, 2024
Registry last updated
Oct 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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