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Device

Dual chamber pacemaker for Heart Failure (PACE HFpEF Trial)

N/A

Waitlist Available

Research Sponsored by Daniel L Lustgarten

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 at 1 month, 2 months, 3 months, 4 months and 5 months

Awards & highlights

PACE HFpEF Trial Summary

This trial is designed to study the effects of lower heart rate elevation on symptoms and function in patients with heart failure with preserved ejection fraction (HFpEF). The investigators hypothesize that a personalized lower HR elevation employing physiological conduction system pacing in patients with HFpEF will decrease left atrial and left ventricular filling pressures.

Eligible Conditions

Diastolic Heart Failure

PACE HFpEF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 month, 2 months, 3 months, 4 months and 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 month, 2 months, 3 months, 4 months and 5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 month, 2 months, 3 months, 4 months and 5 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 composite Minnesota-Living-with-Heart-Failure-Questionnaire score

Percent change in NTproBNP

Secondary outcome measures

Burden of AF

Change in 6 minute walk test

Change in left ventricular mass/volume ratio by cardiac MRI

+2 more

Other outcome measures

>= 25% increase in systolic blood pressure

Doubling in baseline Troponin or NTproBNP

Quantitative assessment of the risks of pacemaker implantation

PACE HFpEF Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Bachmann's bundle, His bundle and nocturnal pacingExperimental Treatment3 Interventions

Group II: Bachmann's bundle pacingExperimental Treatment2 Interventions

Group III: Bachmann's bundle and His bundle pacingExperimental Treatment2 Interventions

Group IV: No pacingPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dual chamber pacemaker

2021

N/A

~20

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Daniel L LustgartenLead Sponsor

MedtronicIndustry Sponsor

605 Previous Clinical Trials

828,216 Total Patients Enrolled

90 Trials studying Heart Failure

90,829 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.

Is the research project open to enrollment at this point in time?

"Clinicaltrials.gov confirms that this clinical trial, which was initially posted on February 23rd 2021, is still recruiting patients. The trial's data has been recently updated as of August 10th 2022."

Answered by AI

How many subjects have enrolled in this investigation?

"Affirmative, the information provided on clinicaltrials.gov states that this investigation is presently seeking volunteers for participation. The trial was first advertised to potential participants on February 23rd 2021 and has been recently updated August 10th 2022. A total of 20 candidates must be recruited from 1 site in order for the study to proceed."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Physiologic Accelerated Pacing as a Treatment in Patients With Heart Failure With Preserved Ejection Fraction

Daniel L Lustgarten 2021. "Physiologic Accelerated Pacing as a Treatment in Patients With Heart Failure With Preserved Ejection Fraction". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04546555.