Klinická studie ELEVATE-HFpEF (ELEVATE-HFpEF)
Randomizovaná zkouška ZVÝŠENÉ srdeční stimulační frekvence pro personalizovanou léčbu srdečního selhání se zachovanou ejekční frakcí (ELEVATE-HFpEF)
ELEVATE-HFpEF is a prospective, randomized, controlled, double-blinded, multi-center, global, interventional pivotal study evaluating the safety and efficacy of dual chamber personalized pacing compared to minimal or no pacing for the treatment of patients with heart failure with preserved ejection fraction (HFpEF).
Přehled studie
Postavení
Intervence / Léčba
Detailní popis
This study will evaluate a personalized cardiac pacing rate as a treatment for symptomatic heart failure with preserved ejection fraction (LVEF ≥50%). The intervention is designed to improve health status and other signs and symptoms of heart failure in patients with HFpEF. After enrollment, baseline data will be collected, and subjects will then have a pacemaker implanted. Following successful implant, and prior to pre-hospital discharge, subjects will be randomized 1:1 to one of two study groups. In the first group, subjects will have their pacemaker programmed to dual chamber pacing at a personalized cardiac pacing rate (treatment group) based on their LVEF and height. Subjects randomized to the second group will have their pacemaker programmed to receive ventricular pacing at a non-personalized rate to minimize interference with the subject's intrinsic heart rate (control group).
Subjects will complete 2-month, 6-month, and 12-month visits where data will be collected. At the 12-month visit, the second group (control group) will also be programmed to their personalized cardiac pacing rate. Subjects will complete 14-month, 18-month, and 24-month visits where data will be collected. Following the 24-month visit, additional long-term follow-up visits will occur annually until study completion. The estimated study duration is approximately 4.5 years representing an estimated 24-month enrollment period and 18-month follow-up period.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Dawn Dyer
- Telefonní číslo: 954-682-8334
- E-mail: dawn.dyer@medtronic.com
Studijní místa
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Queensland
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Chermside, Queensland, Austrálie, 4032
- Nábor
- The Prince Charles Hospital
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Victoria
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Melbourne, Victoria, Austrálie, 3004
- Nábor
- The Alfred Hospital
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Edegem, Belgie, 2650
- Nábor
- Universitair Ziekenhuis Antwerpen
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Besançon, Francie, 25030
- Nábor
- Centre Hospitalier Universitaire Besancon - Hôpital Jean Minjoz
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Clermont-Ferrand, Francie, 63003
- Nábor
- Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied
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Nantes, Francie, 44093
- Nábor
- Hôpital Guillaume et René Laënnec - CHU de Nantes
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Toulouse, Francie, 50032
- Nábor
- CHU Toulouse - Hôpital Rangueil
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Hong Kong, Hongkong
- Nábor
- Prince of Wales Hospital
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Hong Kong, Hongkong
- Nábor
- Queen Elizabeth Hospital (Hong Kong)
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Chiba
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Chiba, Chiba, Japonsko, 260-8677
- Nábor
- Chiba University Hospital
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Fukuoka
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Kitakyushu, Fukuoka, Japonsko, 802-8555
- Nábor
- Kokura Memorial Hospital
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Osaka
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Suita, Osaka, Japonsko, 564-8565
- Nábor
- National Cerebral and Cardiovascular Center
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Calgary, Kanada, T2N 2T9
- Nábor
- University of Calgary
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Vancouver, Kanada, V6Z 1Y6
- Nábor
- Saint Pauls Hospital
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Kota Samarahan, Malajsie, 94300
- Nábor
- Sarawak Heart Centre
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Kuala Lumpur, Malajsie, 50400
- Nábor
- Institut Jantung Negara - National Heart Institute
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Oslo, Norsko, 0372
- Nábor
- Oslo Universitetssykehus-Rikshospitalet
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Lübeck, Německo, 23538
- Nábor
- Universitätsklinikum Schleswig-Holstein - Campus Lübeck
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Linz, Rakousko, 4010
- Nábor
- Ordensklinikum Linz GmbH / Elisabethinen
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Ljubljana, Slovinsko, 1000
- Nábor
- University Medical Centre Ljubljana
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Leeds, Spojené království, LS1 3EX
- Nábor
- The Leeds Teaching Hospitals NHS Trust - Leeds General Infirmary
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London, Spojené království, SE1 7EH
- Nábor
- Guys and St. Thomas NHS Foundation Trust - St. Thomas Hospital
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Manchester, Spojené království, M13 9WL
- Nábor
- Manchester University NHS Foundation Trust - Manchester Royal Infirmary
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Arizona
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Phoenix, Arizona, Spojené státy, 85006
- Nábor
- Banner - University Medical Center Phoenix
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California
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Palo Alto, California, Spojené státy, 94304
- Nábor
- Stanford University
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San Francisco, California, Spojené státy, 94107
- Nábor
- Sutter Health Hospital
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Connecticut
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Hartford, Connecticut, Spojené státy, 06106
- Nábor
- Hartford Hospital
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Florida
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Panama City, Florida, Spojené státy, 32405
- Nábor
- Cardiovascular Institute of Northwest Florida
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Georgia
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Atlanta, Georgia, Spojené státy, 30308
- Nábor
- Emory University
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Illinois
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Chicago, Illinois, Spojené státy, 60637
- Nábor
- The University of Chicago Medical Center
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Iowa
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Des Moines, Iowa, Spojené státy, 50266
- Staženo
- Iowa Heart Center
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Kansas
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Kansas City, Kansas, Spojené státy, 66160
- Nábor
- University of Kansas Medical Center
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Kentucky
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Louisville, Kentucky, Spojené státy, 40295
- Nábor
- Norton Healthcare
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Louisiana
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Houma, Louisiana, Spojené státy, 70360
- Staženo
- Cardiovascular Institute of the South
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Massachusetts
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Boston, Massachusetts, Spojené státy, 02111
- Nábor
- Tufts Medical Center
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Minnesota
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Minneapolis, Minnesota, Spojené státy, 55455
- Nábor
- M Health Fairview University of Minnesota Medical Center - East Bank
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Missouri
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Kansas City, Missouri, Spojené státy, 64111
- Nábor
- Saint Lukes Mid America Heart Institute
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New Mexico
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Albuquerque, New Mexico, Spojené státy, 87106
- Nábor
- Presbyterian Heart Group
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North Carolina
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Durham, North Carolina, Spojené státy, 27710
- Nábor
- Duke University Medical Center
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Ohio
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Columbus, Ohio, Spojené státy, 43210
- Nábor
- The Ohio State University Wexner Medical Center
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Columbus, Ohio, Spojené státy, 43219
- Nábor
- Mount Carmel East
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Pennsylvania
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Lancaster, Pennsylvania, Spojené státy, 17602
- Nábor
- Lancaster General Hospital
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Wynnewood, Pennsylvania, Spojené státy, 19096
- Nábor
- Lankenau Institute for Medical Research
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South Carolina
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Charleston, South Carolina, Spojené státy, 29425
- Nábor
- Medical University of South Carolina (MUSC)
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Tennessee
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Nashville, Tennessee, Spojené státy, 37203
- Nábor
- Saint Thomas Research Institute
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Texas
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Dallas, Texas, Spojené státy, 75216
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- Dallas VA Medical Center
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Fort Worth, Texas, Spojené státy, 76104
- Nábor
- Texas Health Research & Education Institute
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Plano, Texas, Spojené státy, 75093
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- Baylor Research Institute
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Vermont
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Burlington, Vermont, Spojené státy, 05401
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- The University of Vermont Medical Center
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Virginia
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Falls Church, Virginia, Spojené státy, 22042
- Nábor
- Inova Fairfax Hospital
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Washington
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Tacoma, Washington, Spojené státy, 98405
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- Saint Joseph Medical Center (Tacoma WA)
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West Virginia
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Charleston, West Virginia, Spojené státy, 25304
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- Charleston Area Medical Center (CAMC) Memorial Hospital
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Wisconsin
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Milwaukee, Wisconsin, Spojené státy, 53226
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- Froedtert Hospital
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Prague, Česko, 100 34
- Nábor
- Fakultni nemocnice Královské Vinohrady
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Geneva, Švýcarsko, 1205
- Nábor
- Hôpitaux Universitaires de Genève
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
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Age ≥ 40 years
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Documented EF ≥50% within the preceding 12 months
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HFpEF defined as:
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Documented worsening HF episode (either HF hospitalization or documented urgent clinic visit for HF with intravenous diuretics) within 12-months prior to baseline visit OR
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Dyspnea on exertion and New York Heart Association (NYHA) ≥ class II symptoms AND AT LEAST ONE OF THE FOLLOWING CRITERIA:
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Interstitial / pulmonary edema on prior chest imaging in the last year AND current loop diuretic use for heart failure
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Elevated NT-proBNP in the last year defined as >400 pg/m for patients with no AF or paroxysmal AF, or >900 pg/ml for patients with ≥persistent AF
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Mean pulmonary capillary wedge pressure (PCWP) ≥15 mm Hg or LVEDP ≥16 mm Hg at rest on cardiac catheterization OR pulmonary artery diastolic and wedge pressure (PADP) ≥15 mm Hg at rest on implantable monitor (e.g., CardioMEMs)
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Echo criteria defined by ≥2 of:
- LV wall thickness ≥ 12 mm
- LV mass index (BSA indexed LVH): sex at birth male >115 g/m2, sex at birth female >95 g/m2
- Relative wall thickness ≥0.42
- E/e' ≥15 in sinus rhythm (or > 11 in the setting of atrial fibrillation) OR septal <7 cm/s or lateral e' <10cm/s
- Tricuspid regurgitation (TR) velocity >2.8 m/s
- Left atrial (LA) enlargement, defined by LA volume index >34 ml/m2
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Patient is on stable guideline indicated HF medical therapy (Class I recommendations) for at least 30 days
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Patient's average heart rate on baseline ambulatory electrocardiographic monitor is at least 5 bpm lower than their calculated personalized cardiac pacing rate (e.g. if a patient's personalized cardiac pacing rate is 70 bpm and their average heart rate on the ambulatory electrocardiographic monitor is less than or equal to 65 bpm the patient is eligible)
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Patient is willing and able to adhere to the protocol (e.g., patient is able to ambulate independently at baseline).
Exclusion Criteria:
- Improved or recovered EF (i.e., prior LVEF<50%)
- Patient has a previously implanted, currently implanted, or is intended to have implanted a cardiac implantable electronic device capable of delivering pacing (e.g., pacemaker, implantable cardioverter defibrillator (ICD), cardiac resynchronization therapy (CRT))
- Current pregnancy (requirement for negative pregnancy test may vary by jurisdiction)
- Average heart rate <50 bpm or symptomatic bradycardia
- Acute coronary syndrome (including MI), cardiovascular surgery, or urgent percutaneous coronary intervention (PCI) within the 3 months prior to baseline visit or an elective PCI within 30 days prior to baseline visit.
- Current acute decompensated HF requiring intravenous diuretics, vasodilators and/or inotropic drugs.
- Severe obesity defined as BMI >45.
- Persistent, long-standing persistent, or permanent atrial fibrillation (AF) with an average heart rate <50 bpm or evidence of ventricular pauses exceeding 6 seconds
- Planned AF ablation
- Infiltrative cardiomyopathies (e.g., amyloidosis, sarcoidosis)
- Hypertrophic cardiomyopathies
- Uncontrolled hypertension as defined by BP >160/100 mmHg on two measurements ≥15 minutes apart
- End Stage Renal Disease (CKD 4 or greater)
- More than moderate valvular disease (e.g. exclude patients with moderate severe or severe valvular disease)
- Significant primary pulmonary disease on home oxygen
- Known contraindication for a pacemaker implant
- Advanced co-morbidity with life expectancy < 1 year
- Patients who are currently enrolled in a potentially confounding drug or device trial during the course of the study. Co-enrollment in concurrent trials is only allowed when documented pre-approval is obtained from the Medtronic Study Manager.
- Patient is a vulnerable adult (e.g. patient mentally incapable of giving consent).
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Personalized Pacing Therapy (Treatment Group)
The treatment group will receive a qualifying Medtronic dual chamber pacemaker limited to Astra XT or Azure XT and programmed to provide dual chamber pacing at a personalized cardiac pacing rate determined by patient height and baseline LVEF percentage. |
Personalized cardiac pacing treatment based each patient's height and baseline LVEF. |
|
Žádný zásah: Control Group
The control group will receive a qualifying Medtronic dual chamber pacemaker limited to Astra XT or Azure XT and programmed to provide ventricular pacing at a non-personalized rate. This is considered limited or backup pacing. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Primary Efficacy Objective: Hierarchical composite endpoint of cardiovascular mortality, urgent HF events, HF events requiring an oral diuretic intensification (ODI), change in KCCQ, change in six-minute walk test distance, and change in NT-proBNP.
Časové okno: Follow-up duration for endpoint analysis is 12-months.
|
Cardiovascular mortality, urgent heart failure events, and ODI heart failure events will be collected as they occur. The Kansas City Cardiomyopathy Questionnaire (KCCQ); (range of score is 0 to 100), 6-minute walk test (distance in meters), and N-terminal pro-B-type natriuretic peptide (NT-proBNP) (picograms per milliliter, pg/mL) will be collected at Baseline and the 12-months visit. Treatment and control groups will be compared using a win ratio. |
Follow-up duration for endpoint analysis is 12-months.
|
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Primary Safety Objective: Percentage of patients with major complications related to the system or procedure.
Časové okno: 12-months post pacemaker implant attempt.
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Adverse events will be collected as they occur. Adverse events will be adjudicated for their relationship to the implant procedure and system. Severity of adverse events related to the procedure or system will be reviewed to determine if they are major complications. Major complications are defined as complications related to the system or procedure that result in one or more of the following: death, hospitalization, prolonged hospitalization by at least 48 hours, additional surgical intervention, system modification (e.g., reposition, replacement, or explant), and/or permanent loss of device function due to mechanical or electrical dysfunction of the device. The percentage of patients undergoing a pacemaker implant attempt who experience a major complication related to the system or procedure at 12 months. |
12-months post pacemaker implant attempt.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Secondary Objective #1: Compare changes in HF-related health status as measured by the KCCQ-CSS from baseline to 12-months between randomized treatment groups.
Časové okno: Follow-up duration for endpoint analysis is 12-months.
|
KCCQ will be collected at baseline and 12-months and the clinical summary score (CSS) will be computed with a range of 0 to 100, 100 being the best score. The change in KCCQ-CCS will be compared between the treatment and control groups. |
Follow-up duration for endpoint analysis is 12-months.
|
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Secondary Objective #2: Compare the change in NT-proBNP from baseline to 12-months between randomized groups by comparing NT-proBNP measured at baseline and 12-months.
Časové okno: Follow-up duration for endpoint analysis is 12-months.
|
NT-proBNP will be collected at baseline and 12-months. The change in NT-proBNP will be compared between treatment and control groups. |
Follow-up duration for endpoint analysis is 12-months.
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Secondary Objective #3: Compare AF burden as measured by the device between randomized treatment groups.
Časové okno: Follow-up duration for endpoint analysis is 12-months.
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AF burden (percentage of time in atrial fibrillation) is collected by the pacemaker system. AF burden will be compared between treatment and control groups. |
Follow-up duration for endpoint analysis is 12-months.
|
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Secondary Objective #4: Compare the change in 6-minute walk distance from baseline to 12-months between randomized treatment groups.
Časové okno: Follow-up duration for endpoint analysis is 12-months.
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The 6-minute walk test will be performed at baseline and 12-months. The change in walk test distance (in meters) from baseline to 12-months will be compared between the treatment and control groups. |
Follow-up duration for endpoint analysis is 12-months.
|
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Secondary Objective #5: Compare device measured physical activity between randomized treatment groups during the 12-month follow-up period.
Časové okno: Follow-up duration for endpoint analysis is 12-months.
|
Physical activity (hours per day) is collected by the pacemaker system. The average physical activity during the 12-month follow-up period will be compared between the treatment and control group. |
Follow-up duration for endpoint analysis is 12-months.
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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