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Comparison of His Bundle Pacing and Bi-Ventricular Pacing in Heart Failure With Atrial Fibrillation

Primary Purpose

Heart Failure, Atrial Fibrillation

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

CRT Device and Bi-ventricular pacing

CRT Device and His-bundle Pacing

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Heart Failure, Atrial Fibrillation, CRT, BiVP, HBP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject is at least 18 years old
Subject or authorized legal guardian or representative has signed and dated the Informed
Subject is expected to remain available for follow-up visits at the study center
Subjects with heart failure NYHA Class II-IV
Subjects with LVEF no greater than 40%
Subjects with persistent atrial fibrillation or atrial flutter with uncontrolled ventricular rate

Exclusion Criteria:

Subjects with the width of ECG Q, R, S wave (QRS) complex >120ms
Subjects with life expectancy less than 3 years
Subjects with mechanical right heart valve
Subjects with primary valvular disease
Subjects with heart transplant, or is currently on a heart transplant list
Subjects who are pregnant, or of childbearing potential and not on a reliable form of birth control
Subjects with significant renal dysfunction, as manifested by serum creatinine level >2.5 mg/dl or ≥275 μmol/L or estimated glomerular filtration rate (GFR) ≤30 mL/min/1.72 m2, which is documented within the 30 days prior to enrollment or at baseline.
Subjects with significant hepatic dysfunction, as evidenced by a hepatic function panel (serum) > 3 times upper limit of normal, which is documented within the 30 days prior to enrollment or at baseline.
Subjects with chronic or treatment-resistant severe anemia (hemoglobin <10.0 g/dL), which is documented within the 30 days prior to enrollment or at baseline

Sites / Locations

First Affliated Hospital, Wenzhou Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

HBP Group

BiVP Group

Arm Description

CRT Device and His-bundle Pacing. Patients will get His-bundle pacing through a CRT device first for 9 months then switch to Bi-ventricular pacing by the same CRT device for another 9 months.

CRT Device and Bi-ventricular Pacing. Patients will get BiV pacing for 9 months through a CRT device then switch to His-bundle pacing by the same CRT device for another 9 months.

Outcomes

Primary Outcome Measures

Change of LVEF(%) from baseline in HBP and BiV Group

Secondary Outcome Measures

Change of 6min walking distance (m) from the baseline

Change of LV end diastolic diameter(mm) from baseline

Change of LV end systolic diameter(mm) from baseline

The number of heart failure hospitalization after the procedure group

Change of Quality of Life

The Short Form (36) Health Survey (SF-36) Questionnaire

Change of Average sensing amplitude (V)

Change of average pacing threshold (V)

Change of average pacing impedance (ohm)

Change of New York Heart Association (NYHA) Classification from baseline

The number of patients with heart failure hospitalization after the procedure

Full Information

NCT ID

NCT02805465

First Posted

May 30, 2016

Last Updated

June 15, 2016

Sponsor

First Affiliated Hospital of Wenzhou Medical University

Collaborators

HT-Med Company, Chinese Academy of Medical Sciences, Fuwai Hospital, Shanghai Zhongshan Hospital, Jiangsu People's Hospital, Wuhan Asia Heart Hospital, Sir Run Run Shaw Hospital, Shanxi People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02805465

Brief Title

Comparison of His Bundle Pacing and Bi-Ventricular Pacing in Heart Failure With Atrial Fibrillation

Official Title

Comparison of His Bundle Pacing (HBP) and Bi-Ventricular Pacing(BiVP) in Heart Failure (HF) Patients With Atrial Fibrillation (AF) Who Need Atrial-Ventricular Node (AVN) Ablation

Study Type

Interventional

2. Study Status

Record Verification Date

June 2016

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

July 2018 (Anticipated)

Study Completion Date

July 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

First Affiliated Hospital of Wenzhou Medical University

Collaborators

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is a multicenter, prospective, randomized cross-over study to compare His Bundle Pacing (HBP) with Bi-Ventricular Pacing (BiVP) in HF Patients with AF who need atrial-ventricular node ablation.

Detailed Description

Patients who meet the inclusion and exclusion criteria will be enrolled into the study. In the study, both atrial-ventricular node(AVN) ablation and Cardiac Resynchronization Therapy (CRT) implantation are performed with HBP lead implanted and connected with the A port of CRT device. Followed with successful AVN ablation, HBP lead and CRT implantation, patients are 1:1 randomized into BiVP and HBP group for 9 months and then crossover for another 9 months. The primary end points of the study is the change of left ventricular ejection fraction (LVEF) in both HBP and BiV pacing group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Atrial Fibrillation

Keywords

Heart Failure, Atrial Fibrillation, CRT, BiVP, HBP

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HBP Group

Arm Type

Experimental

Arm Description

CRT Device and His-bundle Pacing. Patients will get His-bundle pacing through a CRT device first for 9 months then switch to Bi-ventricular pacing by the same CRT device for another 9 months.

Arm Title

BiVP Group

Arm Type

Active Comparator

Arm Description

CRT Device and Bi-ventricular Pacing. Patients will get BiV pacing for 9 months through a CRT device then switch to His-bundle pacing by the same CRT device for another 9 months.

Intervention Type

Device

Intervention Name(s)

CRT Device and Bi-ventricular pacing

Intervention Description

Bi-ventricular pacing by a CRT device

Intervention Type

Device

Intervention Name(s)

CRT Device and His-bundle Pacing

Intervention Description

His-bundle pacing by a CRT device through the pacing lead at His-bundle region

Primary Outcome Measure Information:

Title

Change of LVEF(%) from baseline in HBP and BiV Group

Time Frame

18 months

Secondary Outcome Measure Information:

Title

Change of 6min walking distance (m) from the baseline

Time Frame

18 months

Title

Change of LV end diastolic diameter(mm) from baseline

Time Frame

18 months

Title

Change of LV end systolic diameter(mm) from baseline

Time Frame

18 months

Title

The number of heart failure hospitalization after the procedure group

Time Frame

18 months

Title

Change of Quality of Life

Description

The Short Form (36) Health Survey (SF-36) Questionnaire

Time Frame

18 months

Title

Change of Average sensing amplitude (V)

Time Frame

18 months

Title

Change of average pacing threshold (V)

Time Frame

18 months

Title

Change of average pacing impedance (ohm)

Time Frame

18 months

Title

Change of New York Heart Association (NYHA) Classification from baseline

Time Frame

18 months

Title

The number of patients with heart failure hospitalization after the procedure

Time Frame

18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is at least 18 years old Subject or authorized legal guardian or representative has signed and dated the Informed Subject is expected to remain available for follow-up visits at the study center Subjects with heart failure NYHA Class II-IV Subjects with LVEF no greater than 40% Subjects with persistent atrial fibrillation or atrial flutter with uncontrolled ventricular rate Exclusion Criteria: Subjects with the width of ECG Q, R, S wave (QRS) complex >120ms Subjects with life expectancy less than 3 years Subjects with mechanical right heart valve Subjects with primary valvular disease Subjects with heart transplant, or is currently on a heart transplant list Subjects who are pregnant, or of childbearing potential and not on a reliable form of birth control Subjects with significant renal dysfunction, as manifested by serum creatinine level >2.5 mg/dl or ≥275 μmol/L or estimated glomerular filtration rate (GFR) ≤30 mL/min/1.72 m2, which is documented within the 30 days prior to enrollment or at baseline. Subjects with significant hepatic dysfunction, as evidenced by a hepatic function panel (serum) > 3 times upper limit of normal, which is documented within the 30 days prior to enrollment or at baseline. Subjects with chronic or treatment-resistant severe anemia (hemoglobin <10.0 g/dL), which is documented within the 30 days prior to enrollment or at baseline

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Weijian Huang, MD

Phone

+86 138-0669-1086

weijianhuang69@126.com

First Name & Middle Initial & Last Name or Official Title & Degree

Lan Su, MD

Phone

+86 137-3874-2616

2512057600@qq.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Weijian Huang, MD

Organizational Affiliation

Wenzhou 1st Affliated Hopsital, Wenzhou Medical University

Official's Role

Principal Investigator

Facility Information:

Facility Name

First Affliated Hospital, Wenzhou Medical University

City

Wenzhou

State/Province

Zhejiang

ZIP/Postal Code

325000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Weijian Huang, MD

Phone

+86 138-0669-1086

weijianhuang69@126.com

First Name & Middle Initial & Last Name & Degree

Lan Su

Phone

+86 137-3874-2616

2512057600@qq.com

First Name & Middle Initial & Last Name & Degree

Weijian Huang, MD

First Name & Middle Initial & Last Name & Degree

Lan Su, MD

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Comparison of His Bundle Pacing and Bi-Ventricular Pacing in Heart Failure With Atrial Fibrillation

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