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Procedure

PITA-HF: Feasibility, Safety, and Tolerability

N/A
Waitlist Available
Led By Kavita Sharma, MD
Research Sponsored by Johns Hopkins University
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 up to 3 months
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a new treatment called PITA, which uses a pacemaker to temporarily make the heart's beats uncoordinated. It aims to help heart failure patients with dilated cardiomyopathy who can't use standard CRT. The treatment could improve heart function by mimicking the benefits of CRT.

Eligible Conditions
  • Heart Failure
  • Dilated Cardiomyopathy
  • Congestive Heart Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility as assessed by percent ventricular capture through Holter monitoring
Safety as assessed by number of arrhythmia episodes via device interrogation
Safety as assessed by number of tachytherapies delivered by ICDs
+7 more
Secondary study objectives
Change in N-terminal pro b-type natriuretic peptide (NT pro-BNP) values
Change in serum blood urea nitrogen (BUN) values
Change in serum creatinine values (mg/dL)
+3 more
Other study objectives
Change in left ventricular (LV) chamber dimensions
Change in left ventricular (LV) ejection fraction

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: PITA ParticipantsExperimental Treatment1 Intervention
All patients in the study are part of the "PITA" arm, where PITA will be on for Weeks 0-8, and off from Weeks 8-12.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PITA
2020
N/A
~10

Find a Location

Who is running the clinical trial?

MedtronicIndustry Sponsor
619 Previous Clinical Trials
764,080 Total Patients Enrolled
92 Trials studying Heart Failure
91,963 Patients Enrolled for Heart Failure
Johns Hopkins UniversityLead Sponsor
2,339 Previous Clinical Trials
14,881,665 Total Patients Enrolled
24 Trials studying Heart Failure
10,021 Patients Enrolled for Heart Failure
Kavita Sharma, MDPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
60 Total Patients Enrolled
1 Trials studying Heart Failure
60 Patients Enrolled for Heart Failure
~2 spots leftby Dec 2025
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