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Device

CRT-P for Heart Failure

N/A

Waitlist Available

Led By Yong-Mei Cha, MD

Research Sponsored by Yong-Mei Cha

Eligibility Criteria Checklist

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

Must have

Patient is able to receive a transvenous pectoral CRT implant

NYHA class I-II

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 12 months

Awards & highlights

Study Summary

This trial will study whether CRT is effective and safe in patients with mild HF and LBBB.

Who is the study for?

This trial is for adults with mild heart failure and left bundle branch block who can consent to the study. They must have a specific range of reduced heart function, be in certain health classes, and on stable heart medication for 6 months. Pregnant women or those not using birth control are excluded.Check my eligibility

What is being tested?

The trial is testing the safety and effectiveness of a pacemaker therapy called CRT-P in patients with mild heart failure and LBBB to see if it improves their condition.See study design

What are the potential side effects?

While not explicitly listed, potential side effects may include discomfort at the implant site, infection risk from surgery, possible lead displacement or device malfunction.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can have a heart device implanted in my chest.

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My heart condition does not severely limit my physical activity.

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I have had two heart scans to check my heart's pumping ability.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 12 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

Change in Left Ventricle End-Systolic Volume Index (LVESVI)

Number of Subjects Not Experiencing Any System-Related Complications

Secondary outcome measures

Number of Subjects Admitted to the Hospital for Heart Failure

Number of Subjects Who Die in One Year

Number of Subjects Who Experience Sustained Ventricular Tachycardia or Fibrillation Greater than 30 Seconds

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: CRT-On first, then CRT-OffExperimental Treatment1 Intervention

Subjects will be randomized to have the cardiac resynchronization therapy pacemaker (CRT-P) programmed on in the first intervention period, and after six months the CRT function will be turned off in the second intervention period.

Group II: CRT-Off first, then CRT-OnExperimental Treatment1 Intervention

Subjects will be randomized to have the cardiac resynchronization therapy pacemaker (CRT-P) programmed off in the first intervention period, and after six months the CRT function will be turned on in the second intervention period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cardiac resynchronization therapy pacemaker (CRT-P)

2018

N/A

~80

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Yong-Mei ChaLead Sponsor

1 Previous Clinical Trials

80 Total Patients Enrolled

1 Trials studying Heart Failure

80 Patients Enrolled for Heart Failure

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,833 Previous Clinical Trials

47,306,417 Total Patients Enrolled

206 Trials studying Heart Failure

677,369 Patients Enrolled for Heart Failure

Biotronik SE & Co. KGIndustry Sponsor

110 Previous Clinical Trials

47,306 Total Patients Enrolled

36 Trials studying Heart Failure

18,692 Patients Enrolled for Heart Failure

Media Library

Heart Failure Research Study Groups: CRT-On first, then CRT-Off, CRT-Off first, then CRT-On

Heart Failure Clinical Trial 2023: Cardiac resynchronization therapy pacemaker (CRT-P) Highlights & Side Effects. Trial Name: NCT03420833 — N/A

Frequently Asked Questions

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

Is this research project still taking on participants?

"At present, this clinical trial is open for enrolment. According to the details on clinicaltrials.gov, the study was posted on August 20th 2018 and recently modified in January 3rd 2022."

Answered by AI

Does this investigation have a cap on the number of participants it is taking in?

"Affirmative, the clinicaltrials.gov database specifies that this medical trial is actively accepting applicants. It was first published on August 20th 2018 and most recently revised on January 3rd 2022. The research seeks to enlist 100 individuals at a single site of study."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Metabolic Mapping and Cardiac Resynchronization

Yong-Mei Cha 2018. "Metabolic Mapping and Cardiac Resynchronization". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03420833.