Recruiting

Conduction System vs. Surgical Pacing

Sponsor:

Kansas City Heart Rhythm Research Foundation

Code:

NCT06342492

Conditions

Heart Failure With Reduced Ejection Fraction

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Coronary Sinus Lead Revision

Study Details

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.

Conditions

Heart Failure With Reduced Ejection Fraction

Study ID

NCT06342492

Start date

Nov 7, 2023

Status verified date

Oct, 2024

Completion date

Dec, 2024

Anticipated

Primary completion date

Nov, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Conduction System Pacing

Subjects who had lead placement via conduction system pacing approach

Epicardial Lead Placement

Subjects who had lead placement via transthoracic, epicardial approach

Interventions

Coronary Sinus Lead Revision

Coronary Sinus Lead Revision

Primary outcome measure

  • Need for lead revision [ Time Frame: Procedure Day ]

Central Contacts and Locations

Central contacts

Donita Atkins

816-651-1969datkins@kchrf.com

Locations

Kansas City Heart Rhythm Institute

Recruiting

Overland Park, Kansas, United States, 66211

Contacts

Donita Atkins

816-651-1969Datkins@kchrf.com

Principal Investigator:

Naga Venkata K. Pothineni, MD

More Information

Sponsor

Kansas City Heart Rhythm Research Foundation

Last update posted

Oct 28, 2024

Last verified

Oct, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kansas City Heart Rhythm Research Foundation on 2024-10-28.