REmodeling the Left Ventricle With Atrial Modulated Pacing

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-15

Study Completion Date

2021-03-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Reprogramming to Prevent Progressive Pacemaker-induced Remodelling

NCT03627585

Left Ventricular Dysfunction Heart Failure, Systolic Left Ventricular Failure +1 more

COMPLETED NA

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

NCT04546555

Heart Failure, Diastolic

COMPLETED NA

Effects of Left Ventricular Pacing Optimilization on Cardiac Perfusion, Contractile Force, and Clinical Performance in Patients With Ventricular Dysfunction and Heart Failure

NCT00551681

Left Ventricular Dysfunction Heart Failure

COMPLETED NA

Efficacy Study of Pacemakers to Treat Slow Heart Rate in Patients With Heart Failure

NCT02145351

Heart Failure With a Preserved Ejection Fraction Heart Failure, Diastolic Chronotropic Incompetence

COMPLETED NA

Cardiac Resynchronisation Therapy Versus Rate-responsive Pacing in Heart Failure With Preserved Ejection Fraction

NCT03338374

Diastolic Heart Failure

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Elevated night pacing on

Group Type ACTIVE_COMPARATOR

Elevated night pacing on

Intervention Type DEVICE

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

Elevated night pacing off

Group Type PLACEBO_COMPARATOR

Elevated night pacing off

Intervention Type DEVICE

Device will be programmed to normal lower rates

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Elevated night pacing on

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

Intervention Type DEVICE

Elevated night pacing off

Device will be programmed to normal lower rates

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
* Subject's life expectancy is less than 12 weeks
* Subject with medical condition that precludes the patient from participation in the opinion of the investigator
* Subject has known coronary disease with Class II angina

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No