Biventricular Pacing for Left Ventricular Dysfunction

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Geisinger Health, Danville, PALeft Ventricular Dysfunction+2 MoreHOT-CRT - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study 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
  • Left Ventricular Dysfunction
  • Congestive Heart Failure
  • Cardiomyopathy

Treatment Effectiveness

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: 6 months

6 months
Change in LV end-systolic volume index
Change in NYHA functional class
Change in QRS duration
Change in quality of life (QOL)scores
Composite endpoint of death, HFH, ventricular arrhythmias or crossover
Crossover of treatment from HOT-CRT to BVP or BVP to HOT-CRT
Freedom from major complications or need for CRT lead revision
Heart failure hospitalization (HFH)
Improvement in left ventricular ejection fraction
Ventricular tachycardia or ventricular fibrillation requiring ICD therapy

Trial Safety

Trial Design

2 Treatment Groups

Biventricular Pacing
1 of 2
HOT-CRT
1 of 2

Active Control

100 Total Participants · 2 Treatment Groups

Primary Treatment: Biventricular Pacing · No Placebo Group · N/A

Biventricular Pacing
Device
ActiveComparator Group · 1 Intervention: Biventricular Pacing · Intervention Types: Device
HOT-CRT
Device
ActiveComparator Group · 1 Intervention: HOT-CRT · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months

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
2 Previous Clinical Trials
90 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.

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have moderate to severe heart failure or mild heart failure with a history of heart attack.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.