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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02805465
Recruitment Status : Unknown
Verified June 2016 by Weijiang Huang, First Affiliated Hospital of Wenzhou Medical University.
Recruitment status was:  Recruiting
First Posted : June 20, 2016
Last Update Posted : June 20, 2016
Sponsor:
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
Information provided by (Responsible Party):
Weijiang Huang, First Affiliated Hospital of Wenzhou Medical University

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.

Condition or disease Intervention/treatment Phase
Heart Failure Atrial Fibrillation Device: CRT Device and Bi-ventricular pacing Device: CRT Device and His-bundle Pacing Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HBP Group
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.
Device: CRT Device and Bi-ventricular pacing
Bi-ventricular pacing by a CRT device

Device: CRT Device and His-bundle Pacing
His-bundle pacing by a CRT device through the pacing lead at His-bundle region

Active Comparator: BiVP Group
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.
Device: CRT Device and Bi-ventricular pacing
Bi-ventricular pacing by a CRT device

Device: CRT Device and His-bundle Pacing
His-bundle pacing by a CRT device through the pacing lead at His-bundle region




Primary Outcome Measures :
  1. Change of LVEF(%) from baseline in HBP and BiV Group [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. Change of 6min walking distance (m) from the baseline [ Time Frame: 18 months ]
  2. Change of LV end diastolic diameter(mm) from baseline [ Time Frame: 18 months ]
  3. Change of LV end systolic diameter(mm) from baseline [ Time Frame: 18 months ]
  4. The number of heart failure hospitalization after the procedure group [ Time Frame: 18 months ]
  5. Change of Quality of Life [ Time Frame: 18 months ]
    The Short Form (36) Health Survey (SF-36) Questionnaire

  6. Change of Average sensing amplitude (V) [ Time Frame: 18 months ]
  7. Change of average pacing threshold (V) [ Time Frame: 18 months ]
  8. Change of average pacing impedance (ohm) [ Time Frame: 18 months ]
  9. Change of New York Heart Association (NYHA) Classification from baseline [ Time Frame: 18 months ]
  10. The number of patients with heart failure hospitalization after the procedure [ Time Frame: 18 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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

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): NCT02805465


Contacts
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Contact: Weijian Huang, MD +86 138-0669-1086 weijianhuang69@126.com
Contact: Lan Su, MD +86 137-3874-2616 2512057600@qq.com

Locations
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China, Zhejiang
First Affliated Hospital, Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: Weijian Huang, MD    +86 138-0669-1086    weijianhuang69@126.com   
Contact: Lan Su    +86 137-3874-2616    2512057600@qq.com   
Principal Investigator: Weijian Huang, MD         
Sub-Investigator: Lan Su, MD         
Sponsors and Collaborators
First Affiliated Hospital of Wenzhou Medical University
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
Investigators
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Principal Investigator: Weijian Huang, MD Wenzhou 1st Affliated Hopsital, Wenzhou Medical University
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Responsible Party: Weijiang Huang, Dean of Cardiology, First Affiliated Hospital of Wenzhou Medical University, First Affiliated Hospital of Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT02805465    
Other Study ID Numbers: FirstWenzhouMU001
First Posted: June 20, 2016    Key Record Dates
Last Update Posted: June 20, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Weijiang Huang, First Affiliated Hospital of Wenzhou Medical University:
Heart Failure
Atrial Fibrillation
CRT
BiVP
HBP
Additional relevant MeSH terms:
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Heart Failure
Atrial Fibrillation
Heart Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Pathologic Processes