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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elevated night pacing on | Active Comparator |
| |
| Elevated night pacing off | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elevated night pacing on | Device | Device will be programmed to 100 beats per minute (bpm) for five hours during normal sleep times |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline through 12 week follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Steinhaus, MD | Medtronic CRHF | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona - Sarver Heart Center | Tucson | Arizona | 85724-0001 | United States | ||
| St Joseph's Medical Center |
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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.
All eligible subjects were approached for participation during the entire recruitment period (site activation through enrollment closure) at each participating site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pacing On | Elevated night pacing on: Device will be programmed to 100 beats per minute (bpm) for five hours during normal sleep times for 4 weeks, then therapy will be discontinued |
| FG001 | Pacing Off | Patient will receive no pacing therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Enrolled Patients | All enrolled patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Number | participants | Baseline through 12 week follow-up |
|
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.
Definitions are consistent with clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Elevated Night Pacing On Before Randomization | This arm includes all subjects as assessed from study start until randomization at the 4-week visit. Note that all subjects received elevated night pacing during this period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
The study ended with fewer participants than was desired for the investigation. The study ended due to difficulty finding eligible patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mike Bennett, Clinical Study Manger | Medtronic Inc | 262-362-1956 | mike.s.bennett@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 27, 2018 | Mar 13, 2023 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 1, 2018 | Mar 13, 2023 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 11, 2018 | Mar 13, 2023 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Elevated night pacing off | Device | Device will be programmed to normal lower rates |
|
| Stockton |
| California |
| 95204-6019 |
| United States |
| Northwestern University | Chicago | Illinois | 60611-2969 | United States |
| University of Minnesota Medical Center Fairview | Minneapolis | Minnesota | 55455 | United States |
| Lourdes Cardiology Services | Voorhees Township | New Jersey | 08043-4322 | United States |
| The Lindner Research Center | Cincinnati | Ohio | 45219-2906 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210-1240 | United States |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17604 | United States |
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | 29425-8905 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212-2717 | United States |
| Years |
|
| Sex: Female, Male | Sex not collected for the 3 subjects who failed screening. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| NYHA Class | NYHA = New York Heart Association | Count of Participants | Participants |
|
| OG001 | Elevated Night Pacing Off | Elevated night pacing off: Device will be programmed to normal lower rates |
|
|
| 0 |
| 22 |
| 4 |
| 22 |
| 9 |
| 22 |
| EG001 | Elevated Night Pacing On From Randomization To 8 Weeks | This arm includes subjects that were randomized to continue receiving elevated night pacing at the 4-week visit, as assessed from the 4-week visit to the 8-week visit. | 0 | 9 | 1 | 9 | 1 | 9 |
| EG002 | Elevated Night Pacing Off From Randomization To 8 Weeks | This arm includes subjects that were randomized to discontinue receiving elevated night pacing at the 4-week visit, as assessed from the 4-week visit to the 8-week visit. | 0 | 5 | 2 | 5 | 0 | 5 |
| EG003 | Elevated Night Pacing Off After 8 Weeks | This arm includes all subjects as assessed from the 8-week visit until study exit. Note that no subjects received elevated night pacing during this period. | 0 | 13 | 0 | 13 | 2 | 13 |
| Cardiac failure | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cardiac failure chronic | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Colitis ischaemic | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Ankle fracture | Injury, poisoning and procedural complications | MedDRA (10.0) | Systematic Assessment |
|
| Acute kidney injury | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Nephrolithiasis | Renal and urinary disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
|
| Embolism | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Device intolerance | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| N-terminal prohormone brain natriuretic peptide increased | Investigations | MedDRA (10.0) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment | The patient after 25 mins of the pacemaker being programmed, she said "i don't feel well". she described slight chest pressure, she saw spots, and had a dizzy feeling.; Her blood pressure was unchanged |
|
| Hypotension | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
|
Participating Institution and Principal Investigator may publish the results of work performed under this Agreement, in accordance with the publication strategy described in the Protocol; provided, however, that any such Publication will be provided to Medtronic for review at least forty five (45) days prior to submission or presentation; provided, however, that such publication strategy in no way shall prevent Institution from freely utilizing data for Publication