His Bundle Pacing Versus Coronary Sinus Pacing for Cardiac Resynchronization Therapy

NCT02700425 | Completed Results FDA Device

• 1 other identifier: IRB15-1728
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 8

Brief Summary

The goal of this study is to compare the effectiveness of pacing from a physiologic His bundle (HB) lead position versus with the standard coronary sinus (CS) lead position in subjects with heart failure undergoing cardiac resynchronization therapy (CRT). While placement of left ventricular leads via the coronary sinus has anatomic limitations, we hypothesis that the achievement of QRS narrowing with His bundle capture will be superior for improving systolic function by echocardiographic indices (ejection fraction and strain) and quality of life and decreased rehospitalization and mortality.

Conditions

Congestive Heart Failure

Keywords

Wide QRS; Ventricular Dyssynchrony

Outcome Measures

Primary Outcomes (3)

• Change in Left Ventricular Ejection Fraction (LVEF)

  Change in left ventricular ejection fraction (LVEF) as measured by echocardiography in a blinded core lab.

  baseline and 6 months

• Change in QRS Duration

  Change in QRS duration as measured by electrocardiography

  baseline and 12 months

• Time to First Cardiovascular Hospitalization or Death

  Time to first cardiovascular hospitalization or death in months

  Through study completion, an average of 12 months.

Secondary Outcomes (4)

• New York Heart Association (NYHA) Functional Class Change

  baseline, 6 months, and 12 months

• Quality of Life Change by Kansas City Questionnaire (KCCQ)

  baseline and 12 months

• Time to First Cardiovascular Rehospitalization

  Through study completion, an average of 12 months

• Time to First Treated Ventricular Arrhythmia/Ventricular Tachycardia (VT/VF)

  Through study completion, an average of 12 months

Study Arms (2)

His Bundle Pacing

ACTIVE COMPARATOR

Subjects will be randomized to the HB lead position with their cardiac resynchronization therapy (CRT) pacemaker. HB lead pacing will be performed with the Medtronic SelectSecure™, Model 3830 lead. Delivery of the lead utilizes a deflectable sheath, the Medtronic SelectSite™, Model C304. Both devices are FDA approved for the purpose of HB pacing. It is the only device available which is presently FDA approved for selective HB pacing.

Device: CRT Pacemaker

Coronary Sinus Pacing

ACTIVE COMPARATOR

Subjects will be randomized to the CS lead position with their cardiac resynchronization therapy (CRT) pacemaker. CS lead and CRT device generator selected for implant will be left to the discretion of the operator. Only FDA approved CS leads and CRT generators will be utilized in the study. There are five present manufacturers of CS leads and CRT generators: Biotronik, Boston Scientific, Medtronic, Sorin, and St. Jude Medical.

Device: CRT Pacemaker

Interventions

CRT Pacemaker DEVICE

Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture.

Coronary Sinus Pacing; His Bundle Pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients at least 18 years of age
• LV systolic dysfunction with LVEF ≤ 35%
• Evidence of intraventricular conduction delay with QRS duration \> 120 msec
• NYHA Class II, III, and ambulatory Class IV heart failure with either ischemic or nonischemic cardiomyopathy and patients with NYHA Class I symptoms and ischemic cardiomyopathy
• Left ventricular ejection fraction (LVEF) ≤ 35%, sinus rhythm (SR), left bundle-branch block (LBBB) morphology, and QRS duration ≥ 150 msec, and NYHA Class II, III, or ambulatory Class IV patients on goal-directed medical therapy (GDMT) \[Class I\]
• LVEF ≤ 35%, SR with LBBB with QRS 120-149 msec on GDMT \[Class IIa\]
• LVEF ≤ 35%, SR with non-LBBB with QRS ≥ 150 msec on GDMT \[Class IIa\]
• LVEF ≤ 35%, in AF if medication or AV nodal ablation will allow near 100% pacing \[Class IIa\]
• LVEF ≤ 35% undergoing new or replacement device with anticipated \>40% ventricular pacing on GDMT \[Class IIa\]
• LVEF ≤ 30%, ischemic etiology of HF, SR with LBBB ≥ 150 msec and NYHA Class I symptoms on GDMT \[Class IIb\]
• LVEF ≤ 35%, SR with non-LBBB with QRS 120-149 msec, NYHA Class III/ambulatory Class IV HF on GDMT \[Class IIb\] LVEF ≤ 35%, SR with non-LBBB with QRS ≥ 150 msec, NYHA Class II HF on GDMT \[Class IIb\]

You may not qualify if:

• Existing CRT device
• Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity
• Pregnancy
• Participation in other trials
• Difficulty with follow-up

Sponsors & Collaborators

• University of Chicago: lead
• University of California, Los Angeles: collaborator
• Northwestern University: collaborator
• Rush University Medical Center: collaborator
• Geisinger Clinic: collaborator
• Indiana University: collaborator
• Edward Hospital: collaborator
• Baptist Health, Louisville: collaborator

Study Sites (8)

The University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Edward Hospital

Naperville, Illinois, 60540, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Baptist Health Louisville

Louisville, Kentucky, 40207, United States

Location

Geisinger Wyoming Valley Medical Center

Wilkes-Barre, Pennsylvania, 18711, United States

Location

Related Publications (2)

• Upadhyay GA, Vijayaraman P, Nayak HM, Verma N, Dandamudi G, Sharma PS, Saleem M, Mandrola J, Genovese D, Tung R; His-SYNC Investigators. His Corrective Pacing or Biventricular Pacing for Cardiac Resynchronization in Heart Failure. J Am Coll Cardiol. 2019 Jul 9;74(1):157-159. doi: 10.1016/j.jacc.2019.04.026. Epub 2019 May 9. No abstract available.

  PMID: 31078637 RESULT

• Upadhyay GA, Vijayaraman P, Nayak HM, Verma N, Dandamudi G, Sharma PS, Saleem M, Mandrola J, Genovese D, Oren JW, Subzposh FA, Aziz Z, Beaser A, Shatz D, Besser S, Lang RM, Trohman RG, Knight BP, Tung R; His-SYNC Investigators. On-treatment comparison between corrective His bundle pacing and biventricular pacing for cardiac resynchronization: A secondary analysis of the His-SYNC Pilot Trial. Heart Rhythm. 2019 Dec;16(12):1797-1807. doi: 10.1016/j.hrthm.2019.05.009. Epub 2019 May 13.

  PMID: 31096064 RESULT

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

This pilot study was underpowered to detect differences less than 10% between groups.The criteria for LBBB definitions impact the outcomes of CRT studies. More precise electrophysiologic definitions are necessary to refine patient selection for His bundle pacing. Longer helices, deflectable sheaths with septal orientation and variable curves may further improve His correction rates and stability of thresholds.

Results Point of Contact

• Title: Dr. Gaurav A. Upadhyay, MD
• Organization: The University of Chicago

gupadhyay@medicine.bsd.uchicago.edu

773-702-5988

Study Officials

• Roderick Tung, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

• Gaurav A. Upadhyay, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2016
• First Posted: March 7, 2016
• Study Start: May 17, 2016
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: September 5, 2021
• Results First Posted: August 10, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)