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

Wenzhou Medical University

Status: Unknown

Conditions: Atrial Fibrillation; Heart Failure

Treatments: Device: CRT Device and His-bundle Pacing; Device: CRT Device and Bi-ventricular pacing

Study type: Interventional

Funder types: Other

Identifiers

NCT02805465

FirstWenzhouMU001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 2 patient groups

HBP Group

Experimental group

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.

Treatment:

Device: CRT Device and His-bundle Pacing

Device: CRT Device and Bi-ventricular pacing

BiVP Group

Active Comparator group

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.

Treatment:

Device: CRT Device and His-bundle Pacing

Device: CRT Device and Bi-ventricular pacing