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Procedure
PITA for Dilated Cardiomyopathy
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
- Dilated Cardiomyopathy
- Heart Failure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
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 moreSecondary 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 moreOther 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
616 Previous Clinical Trials
763,873 Total Patients Enrolled
Johns Hopkins UniversityLead Sponsor
2,321 Previous Clinical Trials
14,873,933 Total Patients Enrolled
Kavita Sharma, MDPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
60 Total Patients Enrolled
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