His Bundle Pacing in Bradycardia and Heart Failure

Sponsor

Yong-Mei Cha (Other)

Overall Status

Recruiting

CT.gov ID

NCT03008291

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Participants in this study will either have heart failure (HF) and are scheduled to undergo cardiac resynchronization therapy pacemaker (CRT-P) or cardiac resynchronization therapy defibrillator (CRT-D) implantation, or have atrioventricular (AV) block and are scheduled to undergo dual chamber pacemaker implantation. In this study additional heart rhythm measurements will be collected during the implant procedure to better understand how His bundle and/or parahisian pacing (HISP) effects electrical conduction in the hearts of patients with HF or AV block.

The hypothesis is that His bundle or parahisian pacing (HISP) may normalize atrioventricular (AV) conduction with a narrow combination of the Q wave, R wave and S wave (QRS complex) in functional bundle branch block or conduction delay in patients with heart failure (HF).

Condition or Disease	Intervention/Treatment	Phase
Bradycardia Heart Failure	Procedure: CRT-D Implantation Procedure: CRT-P Implantation Procedure: Dual Chamber Pacemaker Implantation

Study Design

Study Type:

Observational

Anticipated Enrollment :

40 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

His Bundle Pacing in Bradycardia and Heart Failure

Study Start Date :

Oct 1, 2016

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Heart Failure Group Patients who have left bundle branch block (LBBB), right bundle branch block (RBBB) or interventricular conduction delay (IVCD) with a QRS duration of greater than 120 ms and left ventricular ejection fraction (LVEF) ≤ 35% will be enrolled in this arm. The primary care physician will have recommended either CRT-D Implantation or CRT-P Implantation. (This is Standard of Care for this patient population; the procedures will occur even if the patient does not participate in the study.)	Procedure: CRT-D Implantation Cardiac resynchronization therapy defibrillator Procedure: CRT-P Implantation Cardiac resynchronization therapy pacemaker
Atrioventricular Block Group Patients who have developed second or third degree atrioventricular block (AV block). The primary care physician will have recommended dual chamber pacemaker implantation. (This is Standard of Care for this patient population; the procedures will occur even if the patient does not participate in the study.)	Procedure: Dual Chamber Pacemaker Implantation

Arm

Intervention/Treatment

Heart Failure Group

Patients who have left bundle branch block (LBBB), right bundle branch block (RBBB) or interventricular conduction delay (IVCD) with a QRS duration of greater than 120 ms and left ventricular ejection fraction (LVEF) ≤ 35% will be enrolled in this arm. The primary care physician will have recommended either CRT-D Implantation or CRT-P Implantation. (This is Standard of Care for this patient population; the procedures will occur even if the patient does not participate in the study.)

Procedure: CRT-D Implantation

Cardiac resynchronization therapy defibrillator

Procedure: CRT-P Implantation

Cardiac resynchronization therapy pacemaker

Atrioventricular Block Group

Patients who have developed second or third degree atrioventricular block (AV block). The primary care physician will have recommended dual chamber pacemaker implantation. (This is Standard of Care for this patient population; the procedures will occur even if the patient does not participate in the study.)

Procedure: Dual Chamber Pacemaker Implantation

Outcome Measures

Primary Outcome Measures

QRS duration as measured by 12-lead ECG [Baseline to 6 months]
The normal duration (interval) of the QRS complex is 0.08 and 0.10 seconds (80 and 100 ms). When the duration is between 0.10 and 0.12 seconds it is intermediate or slightly prolonged. A QRS duration of greater than 0.12 seconds is considered abnormal.
QRS morphology as measured by 12-lead ECG [Baseline to 6 months]
Normal QRS width is 70-100 ms (a duration of 110 ms is sometimes observed in healthy subjects). The QRS width is useful in determining the origin of each QRS complex (e.g. sinus, atrial, junctional or ventricular).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

HF Group

Recommended to undergo CRT-P or CRT-D implantation
LBBB, RBBB or IVCD with a QRS duration > 120 ms
LVEF ≤ 35%

AV Block Group

Recommended to undergo dual chamber pacemaker implantation
Second or third degree AV block

Exclusion Criteria:

Age < 18 years
Pregnant

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Rochester	Minnesota	United States	55905

Sponsors and Collaborators

Yong-Mei Cha

Investigators

Principal Investigator: Yong-Mei Cha, M.D., Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Mayo Clinic Clinical Trials

Publications

None provided.

Responsible Party:

Yong-Mei Cha, M.D., Professor of Medicine, Mayo Clinic

ClinicalTrials.gov Identifier:

NCT03008291

Other Study ID Numbers:

16-005100

First Posted:

Jan 2, 2017

Last Update Posted:

Jan 21, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Heart Failure

Bradycardia

Study Results

No Results Posted as of Jan 21, 2022