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

Status: Completed

Location: See location...

Intervention Type: Device

Study Type: Interventional

Study Phase: Not Applicable

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• 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

Locations

United States

Pennsylvania

Geisinger Health

Danville

Time Frame

Start Date: 2021-04-15

Completion Date: 2023-09-30

Participants

Target number of participants: 100

Treatments

Active_comparator: HOT-CRT

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.

Active_comparator: Biventricular Pacing

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.

Authors

Angela Naperkowski, Pugazhendhi Vijayaraman, Vernon Mascarenhas, Faiz Subzposh, Randle Storm, Parash Pokharel, Terry Bauch

Related Therapeutic Areas

Cardiomyopathy

Heart Failure

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

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