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Procedure

PITA for Heart Failure

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
Patient ≥18 years of age
Ejection fraction of <40% by noninvasive testing (TTE, nuclear stress, cardiac MRI) within 6 months of study enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights

Study Summary

This trial is testing a new treatment for heart failure called pacemaker induced transient dyssynchrony (PITA). This treatment involves using a pacemaker to purposely induce dyssynchrony (abnormal electrical impulse propagation) for several hours each day and then reversing this for the remainder of the time. The trial will test the feasibility, safety, and tolerability of PITA in humans with dilated cardiomyopathy. If successful, this study could lead to a larger study to assess the effectiveness of PITA in treating heart failure.

Eligible Conditions
  • Heart Failure
  • Dilated Cardiomyopathy

Eligibility Criteria

Inclusion Criteria

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

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 outcome measures
Change in left ventricular (LV) chamber dimensions
Change in left ventricular (LV) ejection fraction

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
605 Previous Clinical Trials
828,303 Total Patients Enrolled
90 Trials studying Heart Failure
90,841 Patients Enrolled for Heart Failure
Johns Hopkins UniversityLead Sponsor
2,242 Previous Clinical Trials
14,816,629 Total Patients Enrolled
20 Trials studying Heart Failure
4,360 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

Frequently Asked Questions

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

What is the aggregate population size that has joined this trial?

"Affirmative. According to the details posted on clinicaltrials.gov, this medical investigation has begun accepting participants since November 20th 2020 and is still looking for new candidates. They are targeting 8 individuals at a single site."

Answered by AI

What is the principal goal of this clinical research initiative?

"As outlined by Medtronic, the main metric of success in this trial will be Tolerability as assessed via Sleep Quality and monitored over Baseline, Week 4, Week 8, and Week 12. Secondary objectives include quantifying dyssynchrony on echocardiography with an emphasis on interventricular/intraventricular discordance of QRS-complexes to peak pulmonary or aortic valve inflow >40 ms; septal-to-posterior wall motion delay higher than 130 milliseconds; onset/peak systolic velocity of opposing LV walls greater than 65ms; change in sodium levels ("

Answered by AI

Are new participants welcomed for this medical trial?

"The evidence sourced from clinicaltrials.gov suggests that the recruitment process for this investigation is ongoing, having first been posted on November 20th 2020 and last updated on December 7th 2022."

Answered by AI
Recent research and studies
~2 spots leftby Mar 2025