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

NCT04561778 | Completed Results FDA Device

• 1 other identifier: 2020-0831
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure，Congestive; Cardiomyopathies; Left Ventricular Dysfunction

Keywords

Heart Failure; Cardiac Resynchronization Therapy

Outcome Measures

Primary Outcomes (2)

• Primary Endpoint

  Improvement in left ventricular ejection fraction (LVEF) - change in LVEF% measured by 2D echo at 6 months compared to baseline

  6 months

• Primary Safety

  Freedom from major complications or need for CRT lead revision - complication such as lead dislodgment, pericardial tamponade, pneumothorax, systemic embolism, phrenic nerve stimulation not correctable by programming

  6 months

Secondary Outcomes (2)

• Secondary Composite

  6 months

• Echocardiographic Response

  6 months

Study Arms (2)

HOT-CRT

ACTIVE COMPARATOR

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.

Device: HOT-CRT

Biventricular Pacing

ACTIVE COMPARATOR

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.

Device: Biventricular Pacing

Interventions

HOT-CRT DEVICE

Subjects enrolled in the study will receive a permanent cardiac implantable electronic device (CIED) (CRT-pacemaker or CRT-defibrillator) as clinically indicated. Subjects randomized to HOT-CRT will have His bundle pacing lead 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 left ventricular timing may be optimized to achieve maximal resynchronization.

HOT-CRT

Biventricular Pacing DEVICE

Subjects enrolled in the study will receive a permanent CIED (CRT-pacemaker or CRT-defibrillator) as clinically indicated. Subjects randomized to Biventricular pacing will undergo left ventricular lead placement in the coronary sinus venous branches.

Biventricular Pacing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pugazhendhi Vijayaraman: lead

Study Sites (1)

Geisinger Health

Danville, Pennsylvania, 17822, United States

Location

Related Publications (1)

• Vijayaraman P, Pokharel P, Subzposh FA, Oren JW, Storm RH, Batul SA, Beer DA, Hughes G, Leri G, Manganiello M, Jastremsky JL, Mroczka K, Johns AM, Mascarenhas V. His-Purkinje Conduction System Pacing Optimized Trial of Cardiac Resynchronization Therapy vs Biventricular Pacing: HOT-CRT Clinical Trial. JACC Clin Electrophysiol. 2023 Dec;9(12):2628-2638. doi: 10.1016/j.jacep.2023.08.003. Epub 2023 Sep 13.

  PMID: 37715742 DERIVED

MeSH Terms

Conditions

Heart Failure; Cardiomyopathies; Ventricular Dysfunction, Left

Interventions

Cardiac Resynchronization Therapy

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Ventricular Dysfunction

Intervention Hierarchy (Ancestors)

Cardiac Pacing, Artificial; Electric Stimulation Therapy; Therapeutics

Limitations and Caveats

This was a small randomized pilot clinical trial performed in a single health system experienced in HOTCRT. This study was limited to 6 months of follow-up care and was not powered to detect differences in clinical outcomes. The study population was not diverse and included only a small number of women. Future large multicenter randomized controlled studies with longer follow-up times are needed for a comparison of long-term clinical outcomes between HOTCRT and BiV pacing.

Results Point of Contact

• Title: Dr Pugazhendhi Vijayaraman
• Organization: Geisinger Health System

pvijayaraman1@geisinger.edu

5708086020

Study Officials

• Pugazhendhi Vijayaraman, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subjects will be blinded to treatment arm. Echocardiographic evaluation will be performed by study physician blinded to lead placement
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 24, 2020
• Study Start: April 15, 2021
• Primary Completion: May 10, 2023
• Study Completion: September 30, 2023
• Last Updated: August 7, 2024
• Results First Posted: August 7, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)