← Back to Search

Cardiac Resynchronization Therapy

Biventricular Pacing for Cardiomyopathy (HOT-CRT Trial)

N/A

Waitlist Available

Led By Pugazhendhi Vijayaraman, MD

Research Sponsored by Pugazhendhi Vijayaraman

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

HOT-CRT Trial Summary

This trial is testing a new way to pace the heart, which may be better than the current method, and comparing the results of the two methods.

Eligible Conditions

Heart Failure
Cardiomyopathy
Congestive Heart Failure
Left Ventricular Dysfunction

HOT-CRT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Freedom from major complications or need for CRT lead revision

Improvement in left ventricular ejection fraction

Secondary outcome measures

Change in LV end-systolic volume index

Change in NYHA functional class

Change in QRS duration

+5 more

HOT-CRT Trial Design

2Treatment groups

Active Control

Group I: Biventricular PacingActive Control1 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-CRTActive Control1 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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Pugazhendhi VijayaramanLead Sponsor

1 Previous Clinical Trials

20 Total Patients Enrolled

Pugazhendhi Vijayaraman, MD5.05 ReviewsPrincipal Investigator - Geisinger Clinic

Geisinger Clinic

3 Previous Clinical Trials

1,065 Total Patients Enrolled

5Patient Review

I had a great experience with Dr. V Jay at Geisinger Wilkes Barre. I felt like I was in good hands and he was able to answer all of my questions. I would definitely recommend him to anyone.

Media Library

Biventricular Pacing (Cardiac Resynchronization Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04561778 — N/A

Cardiomyopathy Research Study Groups: Biventricular Pacing, HOT-CRT

Cardiomyopathy Clinical Trial 2023: Biventricular Pacing Highlights & Side Effects. Trial Name: NCT04561778 — N/A

Biventricular Pacing (Cardiac Resynchronization Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04561778 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available in this medical research project?

"According to the data available on clinicaltrials.gov, this particular trial is currently seeking suitable participants. Its initial posting was April 15th 2021, with its most recent update taking place May 10th 2022."

Answered by AI

What objectives is this experiment attempting to accomplish?

"This medical trial's main objective is to assess patients' freedom from major complications or need for cardiac resynchronization therapy lead revision over a 6-month period. Secondary outcomes include heart failure hospitalizations, ventricular tachycardia or fibrillation necessitating ICD therapy and changes in left ventricle end-systolic volume index of 15% or more."

Answered by AI

What is the aggregate of participants involved in this trial?

"Confirmed. Details posted on clinicaltrials.gov demonstrate that this research is actively seeking study participants. It was initially released on April 15th 2021 and most recently edited on May 10th 2022, with 100 patients targeted for recruitment at one site only."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Pugazhendhi Vijayaraman 2021. "HIS-Purkinje Conduction System Pacing Optimized Trial of Cardiac Resynchronization Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04561778.