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His Bundle Pacing Versus Coronary Sinus Pacing for Cardiac Resynchronization Therapy (His-SYNC)

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ClinicalTrials.gov Identifier: NCT02700425
Recruitment Status : Recruiting
First Posted : March 7, 2016
Last Update Posted : June 1, 2018
Sponsor:
Collaborators:
University of California, Los Angeles
Northwestern University
Rush University Medical Center
Geisinger Clinic
Indiana University
Edward Hospital
Baptist Health Louisville
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Device: CRT Pacemaker Not Applicable

Detailed Description:

This is a randomized, single-blinded study of 40 patients to a strategy of HB pacing versus CS pacing, and remain blinded to their treatment allocation. Both treatment options use standard-of-care, FDA-approved devices. The distinction is only in the allocation toward HB pacing and CS pacing. Treating physicians will be aware of assignment in order to facilitate routine device follow-up. Echocardiographic and electrocardiographic evaluation will also be performed in a blinded manner.

Cross-over is permitted between treatment group allocation if:

  • CS lead cannot be placed due to difficult cannulation of the CS, limited branches at the posterolateral or lateral wall, or phrenic nerve capture. These subjects may then cross-over to HB pacing.
  • HB pacing subjects may cross-over if HB lead cannot be positioned with adequate stability and reasonable pacing output, or if QRS width does not narrow by at least 20% or to a QRS width of ≤ 130 msec.

Implant procedure will be per routine percutaneous access, as is standard for pacemaker and ICDs. All subjects will receive an FDA-approved cardiac resynchronization therapy pacemaker or defibrillator device, as per standard of care outlined for the subject. In order to facilitate optimal lead placement, arterial access for levo-phase CS angiography and/or LV septal mapping to characterize site of bundle-branch block may also be performed, at the discretion of the implanting physician per his/her standard practice.

Follow-up will be performed at 2 weeks post-implant for incision check and device interrogation as is standard of care. In addition, routine device and clinical follow-up will be scheduled at 1, 3, 6, and 12 months. Electrocardiography (ECG) will be performed pre-implant, prior to hospital discharge, at 3 months, 6 months, and 12 months. Echocardiography will be performed pre-implant and 6 months to evaluate for change in LVEF, chamber dimension, and wall motion with strain imaging as is standard of care in the treatment of patients with advanced heart failure. NYHA functional class and quality of life (utilizing the Kansas City Cardiomyopathy Questionnaire) will be assessed pre-implant and at 6 months.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: His Bundle Pacing Versus Coronary Sinus Pacing for Cardiac Resynchronization Therapy
Actual Study Start Date : May 17, 2016
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Active Comparator: His Bundle Pacing
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
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.

Active Comparator: Coronary Sinus Pacing
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
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.




Primary Outcome Measures :
  1. Change in left ventricular ejection fraction (LVEF) as measured by echocardiography [ Time Frame: baseline and 6 months ]
  2. Change in QRS duration as measured by electrocardiography [ Time Frame: baseline, 3 months, 6 months, and 12 months ]
  3. Time to first cardiovascular hospitalization or death [ Time Frame: through study completion, an average of 12 months ]

Secondary Outcome Measures :
  1. NYHA functional class change [ Time Frame: baseline, 6 months, and 12 months ]
  2. Quality of life change as measured by Kansas City Questionnaire [ Time Frame: baseline, 6 months, and 12 months ]
  3. Time to first cardiovascular rehospitalization [ Time Frame: through study completion, an average of 12 months ]
  4. Time to first treated ventricular arrhythmia (VT/VF) [ Time Frame: through study completion, an average of 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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]

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02700425


Contacts
Contact: Gaurav A. Upadhyay, MD 773-702-5988 gupadhyay@medicine.bsd.uchicago.edu
Contact: Roderick Tung, MD 773-834-0455 rtung1@medicine.bsd.uchicago.edu

Locations
United States, California
The University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Olujimi A. Ajijola, MD, PhD    310-206-6433    oajijola@mednet.ucla.edu   
Contact: Julia Marie Sorg, RN, MSN    310-267-8573    jsorg@mednet.ucla.edu   
Principal Investigator: Olujimi A. Ajijola, MD, PhD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Nishant Verma, MD    312-695-4965    Nishant.Verma@nm.org   
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Parikshit S. Sharma, MD    312-942-0182      
The University of Chicago Recruiting
Chicago, Illinois, United States, 60637
Contact: Gaurav A. Upadhyay, MD    773-702-5988    gupadhyay@medicine.bsd.uchicago.edu   
Contact: Tiffany Hart    773-702-0535    thart@medicine.bsd.uchicago.edu   
Principal Investigator: Gaurav A. Upadhyay, MD         
Edward Hospital Recruiting
Naperville, Illinois, United States, 60540
Contact: Moeen A. Saleem, MD       moeen.saleem@advocatehealth.org   
Contact: Janet Gifford, NP       Janet.Gifford@EEHealth.org   
Principal Investigator: Moeen A. Saleem, MD         
United States, Indiana
Indiana University Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Gopi Dandamudi, MD    317-962-0500    gdandamu@iu.edu   
Contact: Janice Walker, RN, BSN    317-274-0985    jwalker3@iu.edu   
Principal Investigator: Gopi Dandamudi, MD         
United States, Kentucky
Baptist Health Louisville Recruiting
Louisville, Kentucky, United States, 40207
Contact: Kathleen Clark, RN    502-893-7710 ext 4353      
Principal Investigator: John Mandrola, MD         
United States, Pennsylvania
Geisinger Wyoming Valley Medical Center Recruiting
Wilkes-Barre, Pennsylvania, United States, 18711
Contact: Pugazhendhi Vijayaraman, MD    570-808-6020      
Sponsors and Collaborators
University of Chicago
University of California, Los Angeles
Northwestern University
Rush University Medical Center
Geisinger Clinic
Indiana University
Edward Hospital
Baptist Health Louisville
Investigators
Principal Investigator: Roderick Tung, MD University of Chicago
Principal Investigator: Gaurav A. Upadhyay, MD University of Chicago

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT02700425     History of Changes
Other Study ID Numbers: IRB15-1728
First Posted: March 7, 2016    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data shared among sites for final data analysis

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by University of Chicago:
Wide QRS
Ventricular Dyssynchrony

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases