Heart Failure
Conditions
Brief 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.
Interventions
DEVICEElevated night pacing on
Device will be programmed to 100 beats per minute (bpm) for five hours during normal sleep times
DEVICEElevated night pacing off
Device will be programmed to normal lower rates
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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 meets any
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Remained on Study | 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. |
Countries
United States
Participant flow
Recruitment details
All eligible subjects were approached for participation during the entire recruitment period (site activation through enrollment closure) at each participating site.
Pre-assignment details
After completing a baseline visit but before randomization, all subjects received four weeks of elevated night pacing. 8 subjects exited the study before randomization, and are not shown as exits in the study period table. Of these 8 subject exits, 3 exited after enrollment due to screening failures, and 5 exited between the baseline visit and randomization due to withdrawal by subject.
Participants by arm
| Arm | Count |
|---|---|
| Enrolled Patients All enrolled patients | 22 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Enrolled Patients | — |
|---|---|---|
| Age, Continuous | 77.3 Years STANDARD_DEVIATION 8.4 | — |
| NYHA Class Class 1)No symptoms and no limitation in ordinary physical activity | 0 Participants | — |
| NYHA Class Class 2) Slight limitation of physical activity. | 9 Participants | — |
| NYHA Class Class 3) Marked limitation of physical activity. | 8 Participants | — |
| NYHA Class Class 4) Unable to carry on any physical activity without discomfort. Symptoms at rest. | 0 Participants | — |
| NYHA Class Classification not available | 4 Participants | — |
| NYHA Class Subject Does Not have Heart Failure | 1 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 22 participants | — |
| Sex: Female, Male Female | 8 Participants | — |
| Sex: Female, Male Male | 11 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 9 | 0 / 5 | 0 / 13 |
| other Total, other adverse events | 9 / 22 | 1 / 9 | 0 / 5 | 2 / 13 |
| serious Total, serious adverse events | 4 / 22 | 1 / 9 | 2 / 5 | 0 / 13 |
Outcome results
Primary
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.
Time frame: Baseline through 12 week follow-up
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Elevated Night Pacing on | Number of Participants Who Remained on Study | 9 participants |
| Elevated Night Pacing Off | Number of Participants Who Remained on Study | 4 participants |