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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

CRT Device and Bi-ventricular pacing

Intervention Type DEVICE

Bi-ventricular pacing by a CRT device

CRT Device and His-bundle Pacing

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

CRT Device and Bi-ventricular pacing

Intervention Type DEVICE

Bi-ventricular pacing by a CRT device

CRT Device and His-bundle Pacing

Intervention Type DEVICE

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

Interventions

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CRT Device and Bi-ventricular pacing

Bi-ventricular pacing by a CRT device

Intervention Type DEVICE

CRT Device and His-bundle Pacing

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No