Clinical trial NCT04561778: HIS-Purkinje Conduction System Pacing Optimized Trial of Cardiac Resynchronization Therapy
Official title: HIS-Purkinje Conduction System Pacing Optimized Trial of Cardiac Resynchronization Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure，Congestive
Cardiomyopathies
Left Ventricular Dysfunction
Keywords: Heart Failure
Cardiac Resynchronization Therapy
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, prospective, single-blinded trial to determine the overall rate of successful His-Purkinje conduction system pacing Optimized Trial of Cardiac Resynchronization Therapy (HOT-CRT) versus biventricular pacing using coronary sinus lead (BVP) to compare acute and mid-term outcomes. Acute outcomes include change in QRS duration pre-and post-pacing (degree of QRS narrowing) and incidence of major periprocedural complications (pericardial tamponade, need for lead revision, etc.). Mid-term outcomes include echocardiographic response at 6 months along with a composite clinical outcome of heart failure hospitalization, ventricular arrhythmias, crossover, and all-cause mortality.

Detailed description: This is a single-blinded study of 100 patients randomized to a strategy of His-Purkinje conduction system pacing Optimized Trial of Cardiac Resynchronization Therapy (HOT-CRT) versus biventricular pacing using coronary sinus (CS) lead (BVP). Both treatment options use standard-of-care, FDA-approved devices. The distinction is only in the allocation toward HOT-CRT and BVP. Treating physicians will be aware of assignment in order to facilitate routine device follow-up. Echocardiographic and electrocardiographic evaluation will also be performed in a blinded manner.

Cross-over is permitted between treatment group allocation if:

CS lead cannot be placed due to difficult cannulation of the CS, limited branches at the posterolateral or lateral wall, or phrenic nerve capture. These subjects may then cross-over to HOT-CRT.

HOT-CRT subjects may cross-over if His or left bundle pacing lead cannot be positioned with adequate stability and reasonable pacing output, or if optimal QRS narrowing cannot be achieved.

Implant procedure will be per routine percutaneous access, as is standard for pacemaker and Implantable Cardioverter Defibrillators (ICDs). . All subjects will receive an FDA-approved cardiac resynchronization therapy pacemaker or defibrillator device, as per standard of care outlined for the subject.

Follow-up will be performed at 2 weeks post-implant for incision check and device interrogation as is standard of care. In addition, routine device and clinical follow-up will be scheduled at 3 and 6 months. Electrocardiography (ECG) will be performed pre-implant, prior to hospital discharge, at 3 months, and 6 months. Echocardiography will be performed pre-implant and 6 months to evaluate for change in Left Ventricular Ejection Fraction (LVEF), chamber dimensions, volumes, and change in Left Ventricular (LV) end systolic volume index as is standard of care in the treatment of patients with advanced heart failure. New York Heart Association (NYHA) functional class and quality of life (utilizing the Kansas City Cardiomyopathy Questionnaire (KCCQ) and EQ 5D) will be assessed pre-implant and at 6 months.

Eligibility criteria: Inclusion Criteria:

* Patients at least 18 years of age
* Diagnosis is NYHA Class II, III, and ambulatory Class IV heart failure with either ischemic or nonischemic cardiomyopathy and patients with NYHA Class I symptoms and ischemic cardiomyopathy, with at least one of the following:

  * LV systolic dysfunction with LVEF ≤ 35% and Evidence of bundle branch block with QRS duration \> 120 msec
  * LV systolic dysfunction with LVEF ≤ 50% and with need for \>40% Right Ventricular (RV) pacing

Exclusion Criteria:

* Existing CRT device
* Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity
* Pregnancy
* Participation in other device trials
* Inability to complete study requirements

Primary outcomes:
measure: Primary Endpoint
timeFrame: 6 months
measure: Primary Safety
timeFrame: 6 months
Secondary outcomes:
measure: Secondary Composite
timeFrame: 6 months
measure: Echocardiographic Response
timeFrame: 6 months
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Health
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Pugazhendhi Vijayaraman, MD
role: PRINCIPAL_INVESTIGATOR
References: