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REmodeling the Left Ventricle With Atrial Modulated Pacing | Clinical Trials | Clareo Health

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REmodeling the Left Ventricle With Atrial Modulated Pacing

NCT03210402•Medtronic Cardiac Rhythm and Heart Failure

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.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject has had a market released dual chamber Medtronic Pacemaker with a Sleep function for at least 3 months
•Subject is stable on current medications
•Subject has dyspnea with exertion or diagnosed as New York Heart Association (NYHA) Class II or III Heart Failure
•Subject has had a prior Echo in past 6 months with: Ejection Fraction (EF) ≥ 50% and Diastolic volume \<80 ml/m²
•Subject has evidence of hypertrophy (indexed to body surface area: men 115 g/m², women 95 g/m² or indexed to height: men 49.2 g/m2.7, women 46.7 g/m2.7) or Relative Wall thickness \>0.42, or Wall Thickness\>1.2cm (posterior wall)
•Subject is willing to sign and date the study Informed Consent Form (IC Form) - Subject is 18 years of age or older, or of legal age to give informed consent per local law
•Subject is expected to remain available for follow-up visits

Exclusion Criteria

•Subject has permanent atrial fibrillation (AF) or AF noted on baseline interrogation rhythm strip
•Subject has uncontrolled BP; (systolic pressure needs to be \>100 mmHg and \<160 mmHg on medications)
•Subject has severe stenosis of the aortic or mitral valve, defined as valve area ≤1.0 cm² or severe regurgitation of the aortic or mitral valve
•Subject has symptomatic Chronic Obstructive Pulmonary Disease (COPD) requiring oxygen
•Subject's Pacemaker has less than 6 months of Pacemaker battery life
•Subject had an aortic valve replacement (surgical or TAVR) procedure less than 9 months prior to enrollment
•Subject's programmed upper rate limit is less than 100 bpm because of concerns of elevated pacing
•Subject is unable or unwilling to perform the 6 Minute Walk Test at all scheduled study visits
•Subject is currently enrolled or planning to enroll in a potentially confounding trial during the course of the study (co-enrollment in concurrent studies is only allowed when documented pre-approval is obtained from the Medtronic study manager)
•Subject is pregnant
+3 more criteria

Locations (10)

University of Arizona - Sarver Heart Center

Tucson, Arizona, United States

St Joseph's Medical Center

Stockton, California, United States

Northwestern University

Chicago, Illinois, United States

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, United States

Lourdes Cardiology Services

Voorhees Township, New Jersey, United States

The Lindner Research Center

Cincinnati, Ohio, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Lancaster General Hospital

Lancaster, Pennsylvania, United States

Medical University of South Carolina (MUSC)

Charleston, South Carolina, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Key Dates

Start Date

September 15, 2017

Primary Completion Date

March 15, 2021

Completion Date

March 15, 2021

Last Updated

October 8, 2024

Enrollment

ACTUAL participants

Conditions

Heart Failure

Interventions

Elevated night pacing on

DEVICE

Elevated night pacing off

DEVICE

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 8, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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REmodeling the Left Ventricle With Atrial Modulated Pacing

Inclusion Criteria

Exclusion Criteria

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