Heart FailureREVAMPNCT03210402

REmodeling the Left Ventricle With Atrial Modulated Pacing

A study testing Elevated night pacing on and Elevated night pacing off in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Heart Failure
What is being tested?: Elevated night pacing on and Elevated night pacing off
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 10 sitesUnited States
Study dates: 15 Sep 2017to 15 Mar 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 14Show fewer

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 meets any exclusion criteria required by local law
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

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Medical University of South Carolina (MUSC)
Charleston, South Carolina, 29425-8905
Northwestern University
Chicago, Illinois, 60611-2969
The Lindner Research Center
Cincinnati, Ohio, 45219-2906
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210-1240
Lancaster General Hospital
Lancaster, Pennsylvania, 17604
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455
Vanderbilt University Medical Center
Nashville, Tennessee, 37212-2717
St Joseph's Medical Center
Stockton, California, 95204-6019
University of Arizona - Sarver Heart Center
Tucson, Arizona, 85724-0001
Lourdes Cardiology Services
Voorhees Township, New Jersey, 08043-4322

Other trials in United States

About this study

Conditions: Heart Failure
Being tested: Elevated night pacing on, Elevated night pacing off
Medical subject headings: Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Elevated night pacing onDevice
Device will be programmed to 100 beats per minute (bpm) for five hours during normal sleep times
Elevated night pacing offDevice
Device will be programmed to normal lower rates

Study groups in NCT03210402
Study group	Role	What they receive
Elevated night pacing on	Active comparator	Not described Receives: Device: Elevated night pacing on
Elevated night pacing off	Placebo comparator	Not described Receives: Device: Elevated night pacing off

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Remained on Study
REVAMP is a Non-Significant Risk Investigation Device Exemption exploratory/feasibility study. The primary objective is to assess the feasibility of using the elevated night pacing intervention in subjects with heart failure with preserved ejection fraction. This primary objective does not involve statistical analysis, the number of participants that remained on study during each study phase were descriptively summarized.
Measured: Baseline through 12 week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Sep 201715 Mar 2021

First posted6 Jul 2017
Study start15 Sep 2017
Primary completion15 Mar 2021
Study completion15 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Heart FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03210402
Sponsor's protocol ID: REVAMP
Acronym: REVAMP
Status last verified: Sep 2024
First submitted: 27 Feb 2017
Last updated: 8 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure

All Heart Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: REmodeling the Left Ventricle With Atrial Modulated Pacing
ClinicalTrials.gov ID: NCT03210402
Acronym / sponsor ID: REVAMP / REVAMP
Conditions: Heart Failure
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
Study start: 15 Sep 2017 (actual)
Primary completion: 15 Mar 2021 (actual)
Study completion: 15 Mar 2021 (actual)
First posted: 6 Jul 2017 (actual)
Results: Posted 8 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Elevated night pacing on	Active comparator	Device: Elevated night pacing on
Elevated night pacing off	Placebo comparator	Device: Elevated night pacing off

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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)

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Elevated night pacing onDevice will be programmed to 100 beats per minute (bpm) for five hours during normal sleep times	Device	Elevated night pacing on
Elevated night pacing offDevice will be programmed to normal lower rates	Device	Elevated night pacing off

Primary outcome

Number of Participants Who Remained on Study
Time frame: Baseline through 12 week follow-up
REVAMP is a Non-Significant Risk Investigation Device Exemption exploratory/feasibility study. The primary objective is to assess the feasibility of using the elevated night pacing intervention in subjects with heart failure with preserved ejection fraction. This primary objective does not involve statistical analysis, the number of participants that remained on study during each study phase were descriptively summarized.

Results and safety

Results posted to the registry on 8 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pacing On	9	9
Pacing Off	5	4

Primary outcome: Number of Participants Who Remained on Study

Time frame: Baseline through 12 week follow-up. Number. Unit: participants

Measure	Elevated Night Pacing on n = 9	Elevated Night Pacing Off n = 5
Value	9	4

Population analysed: Subjects were randomized to these two arms after an initial 4-week baseline period in which all subjects had their device programmed to provide elevated night pacing.

Adverse events

Time frame: Adverse events were collected for all patients from the time of enrollment through the time of study exit, which occurred 12 weeks after the baseline visit for subjects that did not exit early.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Elevated Night Pacing On Before Randomization	4 of 22 (18.2%)	9 of 22 (40.9%)	0 of 22
Elevated Night Pacing On From Randomization To 8 Weeks	1 of 9 (11.1%)	1 of 9 (11.1%)	0 of 9
Elevated Night Pacing Off From Randomization To 8 Weeks	2 of 5 (40%)	0 of 5 (0%)	0 of 5
Elevated Night Pacing Off After 8 Weeks	0 of 13 (0%)	2 of 13 (15.4%)	0 of 13

Limitations and caveats (from the sponsor): The study ended with fewer participants than was desired for the investigation. The study ended due to difficulty finding eligible patients.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Heart Failure

RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Active, not recruiting
Heart Failure Patient Management and Interventions Using Continuous Patient Monitoring Outside Hospitals and Real-world Data
Chronic Heart Failure, Heart Transplant Recipient
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Not yet recruitingObservational study
Real-world Effectiveness and Safety of Savagen (Sacubitril/Valsartan) in Malaysian HFrEF Patients
Heart Failure With Reduced Ejection Fraction (HFrEF), Heart Failure

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Steinhaus, MD study director

Medtronic CRHF

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Elevated night pacing on and Elevated night pacing off in people with Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Remained on Study (time frame: Baseline through 12 week follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03210402.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.