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REmodeling the Left Ventricle With Atrial Modulated Pacing

NCT03210402 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-10-08

Study results available
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Summary

New therapy tested in heart failure with preserved ejection fraction (HFpEF) patients with approved indications for pacing to determine if elevated pacing therapy is tolerated and whether there is a signal for efficacy.

Conditions

Interventions

DEVICE

Elevated night pacing on

Device will be programmed to 100 beats per minute (bpm) for five hours during normal sleep times

DEVICE

Elevated night pacing off

Device will be programmed to normal lower rates

Sponsors & Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

    lead INDUSTRY

Principal Investigators

  • David Steinhaus, MD · Medtronic CRHF

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-15
Primary Completion
2021-03-15
Completion
2021-03-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03210402 on ClinicalTrials.gov