HIS-Purkinje Conduction System Pacing Optimized Trial of Cardiac Resynchronization Therapy

(HOT-CRT Trial)

Overseen by Pugazhendhi Vijayaraman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Pugazhendhi Vijayaraman

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Pugazhendhi Vijayaraman, MD

Principal Investigator

Geisinger Clinic

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

Exclusion Criteria

Pregnancy

Existing CRT device

Inability of patient capacity to provide consent for themselves either due to medical or psychiatric comorbidity

Treatment Details

Interventions

• Biventricular Pacing (Cardiac Resynchronization Therapy)
• HOT-CRT (Cardiac Resynchronization Therapy)

Participant Groups

Group I: Biventricular Pacing Active Control 1 Intervention

Subjects randomized to biventricular pacing will undergo left ventricular lead placement in the coronary sinus venous branches.Only FDA approved leads and devices will be used.

Group II: HOT-CRT Active Control 1 Intervention

Subjects randomized to HOT-CRT will undergo CRT as described below. His bundle pacing lead will be placed initially to achieve CRT. If complete resynchronization is achieved (BBB normalization) but capture thresholds are high (1.5-2V), the lead may be placed in the distal conduction system (left bundle branch area). If only partial QRS narrowing is achieved, a coronary sinus lead may be placed and LV timing may be optimized to achieve maximal resynchronization. This will be at the discretion of the implanting physician. Only FDA approved leads and devices will be used.

Who Is Running the Clinical Trial?

Pugazhendhi Vijayaraman

Lead Sponsor

Trials

2

Recruited

120+