APPRAISE ATP: Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP
Sponsor
Boston Scientific Corporation (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02923726
Collaborator
(none)
2,600
134
2
96
19.4
0.2
Study Details
Study Description
Brief Summary
The primary objective is to understand the role of antitachycardia pacing (ATP) in primary prevention patients indicated for ICD therapy and programmed according to current guidance of higher rate cut-offs and therapy delays. The time to first all-cause shock will be tested in subjects with standard therapy (ATP and shocks) compared to subjects programmed to shock only to assess equivalency.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
2600 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Assessment of Primary Prevention Patients Receiving An ICD - Systematic Evaluation of ATP (APPRAISE ATP)
Actual Study Start Date
:
Sep 30, 2016
Anticipated Primary Completion Date
:
Oct 1, 2024
Anticipated Study Completion Date
:
Oct 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: ATP and Shock Once tachycardia has been detected and duration met, this group would receive antitachycardia pacing prior to shock therapy. |
Device: Arm 1 (ATP+Shock)
Subjects will be randomized and device programmed to the respective arm.
|
| Experimental: Shock only Once tachycardia has been detected and duration met, this group would receive shock therapy only. |
Device: Arm 2 (shock only)
Subjects will be randomized and device programmed to the respective arm.
|
Outcome Measures
Primary Outcome Measures
- Time-to-First All-Cause Shock [From 60 days post implant up to five years]
Minimum follow up is 18 months and follow up lasts until last patient has completed the 18 month follow up
Secondary Outcome Measures
- • All-cause mortality [From 60 days post implant up to five years]
- Time to first appropriate shock [From 60 days post implant up to five years]
- Time to first inappropriate shock [From 60 days post implant up to five years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
-
Subject with a Boston Scientific transvenous ICD (de novo implant or upgrade from pacemaker to ICD ) implanted because of one of the following:
-
Prior MI and left ventricular ejection fraction (LVEF) less than or equal to (≤ )30% OR
-
Ischemic or non-ischemic cardiomyopathy, and LVEF ≤ 35% , and a New York Heart Association (NYHA) class II or III
-
Subject is age 21or above, or is considered of legal age per given geography
-
Subject is willing and capable of providing informed consent
-
Subject is willing and capable of complying with follow-up visits as defined by this protocol
Exclusion Criteria:
-
History of spontaneous sustained Ventricular Tachycardia (VT) (≥ 160 bpm at ≥ 30 seconds in duration) or Ventricular Fibrillation (VF) not due to a reversible cause
-
NYHA Class IV documented in the medical records within 90 calendar days prior to enrollment
-
Subject is eligible and scheduled for cardiac resynchronization (CRT) implant
-
Subjects with a previous subcutaneous ICD (S-ICD)
-
Subject with existing TV-ICD device implanted for greater than 60 days
-
Subjects with coronary artery bypass graft surgery or percutaneous coronary intervention within the past 90 calendar days prior to enrollment
-
Subjects with documented myocardial infarction within the past 90 calendar days prior to enrollment
-
Subjects on the active heart transplant list
-
Subject who has a ventricular assist device (VAD) or is to receive a VAD
-
Life expectancy shorter than 18 months due to any medical condition (e.g., cancer, uremia, liver failure, etc…)
-
Subjects currently requiring hemodialysis
-
Subject who is known to pregnant or plans to become pregnant over the course of the trial
-
Subject is enrolled in any other concurrent clinical study, with the exception of local mandatory governmental registries and observational studies/registries, without the written approval from Boston Scientific
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Heart Center Research, LLC | Huntsville | Alabama | United States | 35801 |
| 2 | Providence Alaska Medical Center | Anchorage | Alaska | United States | 99508 |
| 3 | Tri-City Cardiology | Mesa | Arizona | United States | 85206 |
| 4 | Cardiovascular Consultants, LTD | Phoenix | Arizona | United States | 85032 |
| 5 | Yuma Regional Medical Center | Yuma | Arizona | United States | 85364 |
| 6 | Arrhythmia Research Group | Jonesboro | Arkansas | United States | 72401 |
| 7 | Mercy Clinic Cardiology | Rogers | Arkansas | United States | 72758 |
| 8 | Comprehensive Cardiovascular Specialists | Alhambra | California | United States | 91801 |
| 9 | Scripps Mercy Chula Vista | Chula Vista | California | United States | 91910 |
| 10 | VA Loma Linda | Loma Linda | California | United States | 92357 |
| 11 | Cardiovascular Consultants Medical Group | Los Angeles | California | United States | 90024 |
| 12 | Sharp Memorial Hospital | San Diego | California | United States | 92123 |
| 13 | South Denver Cardiology Associates PC | Littleton | Colorado | United States | 80120 |
| 14 | Cardiac Specialists | Danbury | Connecticut | United States | 06810 |
| 15 | Stamford Hospital | Stamford | Connecticut | United States | 06902 |
| 16 | Christiana Hospital | Newark | Delaware | United States | 19805 |
| 17 | Bradenton Cardiology | Bradenton | Florida | United States | 34205 |
| 18 | The Cardiac and Vascular Institute Research Foundation | Gainesville | Florida | United States | 32605 |
| 19 | St Vincent's Medical Center | Jacksonville | Florida | United States | 32204 |
| 20 | Heart of the Villages | Lady Lake | Florida | United States | 32159 |
| 21 | Watson Clinic Center for Research, Inc | Lakeland | Florida | United States | 33805 |
| 22 | Charlotte Heart & Vascular | Port Charlotte | Florida | United States | 33952 |
| 23 | Brevard Cardiovascular Research Associates, Inc | Rockledge | Florida | United States | 32955 |
| 24 | Tallahassee Memorial Hospital | Tallahassee | Florida | United States | 32308 |
| 25 | AdventHeatlh Tampa | Tampa | Florida | United States | 33624 |
| 26 | CorVita Science Foundation | Chicago | Illinois | United States | 60605 |
| 27 | Adventist Hinsdale Hospital | Chicago | Illinois | United States | 60612 |
| 28 | Alexian Brothers Medical Center | Elk Grove Village | Illinois | United States | 60007 |
| 29 | Lutheran Medical Group | Fort Wayne | Indiana | United States | 46804 |
| 30 | Ball Memorial Hospital | Muncie | Indiana | United States | 47303 |
| 31 | University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States | 52242 |
| 32 | Mercy Hospital Medical Center | West Des Moines | Iowa | United States | 50266 |
| 33 | Overland Park Regional Medical Center | Overland Park | Kansas | United States | 66215 |
| 34 | Baptist Health Lexington | Lexington | Kentucky | United States | 40503 |
| 35 | Louisiana State University | Shreveport | Louisiana | United States | 71103 |
| 36 | Union Memorial Hospital | Baltimore | Maryland | United States | 21237 |
| 37 | Johns Hopkins Hospital | Baltimore | Maryland | United States | 21287 |
| 38 | Richard A. Henson Research Institute of Peninsula Regional Medical Center | Salisbury | Maryland | United States | 21804 |
| 39 | Lahey Clinic Hospital | Burlington | Massachusetts | United States | 01805 |
| 40 | Southcoast Physicians Group | Fall River | Massachusetts | United States | 02720 |
| 41 | Mass Heart and Rhythm | Leominster | Massachusetts | United States | 01453 |
| 42 | University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | United States | 01655 |
| 43 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
| 44 | Cardiology Consultants of East Michigan | Flint | Michigan | United States | 48532 |
| 45 | Western Michigan University - Homer Stryker M.D. School of Medicine | Kalamazoo | Michigan | United States | 49048 |
| 46 | Great Lakes Heart & Vascular Institute | Saint Joseph | Michigan | United States | 49085 |
| 47 | Munson Medical Center | Traverse City | Michigan | United States | 49684 |
| 48 | Metro Health Hospital | Wyoming | Michigan | United States | 49519 |
| 49 | St. Joseph Mercy Hospital | Ypsilanti | Michigan | United States | 48197 |
| 50 | St. Luke's Hospital of Duluth | Duluth | Minnesota | United States | 55805 |
| 51 | Heart and Vascular Hattiesburg Clinic | Hattiesburg | Mississippi | United States | 39401 |
| 52 | Cox Health | Springfield | Missouri | United States | 65807 |
| 53 | The Nebraska Medical Center | Omaha | Nebraska | United States | 68198 |
| 54 | Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03766 |
| 55 | Cardiovascular Associates of the Delaware Valley. | Haddon Heights | New Jersey | United States | 08035 |
| 56 | Jersey Shore University Medical Center | Neptune | New Jersey | United States | 07753 |
| 57 | St. Joseph's Region Medical Center | Paterson | New Jersey | United States | 07503 |
| 58 | Weill Cornell Medical University | New York | New York | United States | 10021 |
| 59 | Memorial Mission Hospital | Asheville | North Carolina | United States | 28803 |
| 60 | Duke University Medical Center | Durham | North Carolina | United States | 27710 |
| 61 | Wake Forest University School of Medicine | Winston-Salem | North Carolina | United States | 27157 |
| 62 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 63 | Kettering Medical Center | Kettering | Ohio | United States | 45429 |
| 64 | Regional Cardiac Arrhythmia, Inc | Steubenville | Ohio | United States | 43952 |
| 65 | Mount Carmel Columbus Cardiology Consultants | Westerville | Ohio | United States | 43801 |
| 66 | Lehigh Valley Hospital Pocono | Allentown | Pennsylvania | United States | 18103 |
| 67 | Bryn Mawr Medical Specialists | Bryn Mawr | Pennsylvania | United States | 19146 |
| 68 | The Arrhythmia Institute | Newtown | Pennsylvania | United States | 18940 |
| 69 | Presbyterian University of Pennsylvania Medical Center | Philadelphia | Pennsylvania | United States | 19104 |
| 70 | Temple University Hospital | Philadelphia | Pennsylvania | United States | 19140 |
| 71 | Trident Medical Center | Charleston | South Carolina | United States | 29406 |
| 72 | McLeod Cardiology Associates | Florence | South Carolina | United States | 29506 |
| 73 | Lexington Medical Center | West Columbia | South Carolina | United States | 29169 |
| 74 | Monument Health Rapid City Hospital, Inc. | Rapid City | South Dakota | United States | 57701 |
| 75 | VA North Texas Health Care System in Dallas | Dallas | Texas | United States | 75216 |
| 76 | Apex Trials Group, LLC | Fort Worth | Texas | United States | 76104 |
| 77 | University of Texas Houston Health Science Center | Houston | Texas | United States | 77030 |
| 78 | Heart Institute of East Texas | Lufkin | Texas | United States | 75904 |
| 79 | Mission Research Institute | New Braunfels | Texas | United States | 78130 |
| 80 | McKay Dee Cardiology | Ogden | Utah | United States | 84403 |
| 81 | University of Utah Hospitals and Clinics | Salt Lake City | Utah | United States | 84132 |
| 82 | VA Salt Lake City Health System | Salt Lake City | Utah | United States | 84148 |
| 83 | Bon Secours Heart & Vascular Institute | Mechanicsville | Virginia | United States | 23116 |
| 84 | Sentara Norfolk General Hospital | Norfolk | Virginia | United States | 23507 |
| 85 | Virginia Cardiovascular Specialist | Richmond | Virginia | United States | 23225 |
| 86 | Providence Regional Medical Centre Everett | Everett | Washington | United States | 98201 |
| 87 | PeaceHealth Southwest Medical | Vancouver | Washington | United States | 98664 |
| 88 | Charleston Area Medical Center | Charleston | West Virginia | United States | 25304 |
| 89 | Bellin Health | Green Bay | Wisconsin | United States | 54305 |
| 90 | Kepler Universitaetsklinikum GmbH | Linz | Austria | 4021 | |
| 91 | Klinikum Wels-Grieskirchen GmbH | Wels | Austria | 4600 | |
| 92 | Royal Alexandra Hospital | Edmonton | Alberta | Canada | T5H 3V9 |
| 93 | Royal Columbian Hospital | New Westminster | British Columbia | Canada | V3L 3W4 |
| 94 | Victoria Cardiac Arrhythmia Trials, Inc. | Victoria | British Columbia | Canada | V8T 1Z4 |
| 95 | Hamilton General Hospital | Hamilton | Ontario | Canada | L8L 2X2 |
| 96 | Scarborough Health Network-Centenary Site | Scarborough | Ontario | Canada | M1B 4Z8 |
| 97 | Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | Canada | H2W 1T8 |
| 98 | Institut de Cardiologie de Montreal | Montréal | Quebec | Canada | H1T 1C8 |
| 99 | Institut universitaire de Cardiologie et de Pneumologie de Quebec. | Quebec City | Quebec | Canada | G1V 4G5 |
| 100 | Policlinico di Modena | Modena | Emilia-Romagna | Italy | 41124 |
| 101 | Osp. Civile S. Maria Delle Grazie | Pozzuoli | Southern Cluster | Italy | 80018 |
| 102 | Presidio Ospedale San Giovanni Bosco | Napoli | Italy | 80100 | |
| 103 | Hospital Buon Consiglio | Napoli | Italy | 80123 | |
| 104 | Ospedale dei Pellegrini | Napoli | Italy | 8133 | |
| 105 | Az. Osp. S. Andrea | Rome | Italy | 00189 | |
| 106 | Chiba University Hospital | Chiba-shi | Chiba | Japan | 260-8677 |
| 107 | Kokura Memorial Hospital | Kitakyushu-Shi | Fukuoka | Japan | 802-8555 |
| 108 | Kitasato University Hospital | Sagamihara-shi | Kanagawa | Japan | 252-0375 |
| 109 | Kumamoto University Hospital | Kumamoto-shi | Kumamoto, | Japan | 860-8556 |
| 110 | Kyoto University Hospital | Kyoto | Kyoto-shi, | Japan | 606-8507 |
| 111 | Tachikawa General Hospital | Nagaoka-shi | Niigata | Japan | 940-8621 |
| 112 | Niigata University Medical and Dental Hospital | Niigata-shi | Niigata | Japan | 951-8520 |
| 113 | National Crebral and Cardiovascular Center Hospital | Suita | Osaka | Japan | 565-8565 |
| 114 | Saitama Medical University International Medical Cnter | Hidaka-shi | Saitama | Japan | 350-1298 |
| 115 | Chonnam National University | Gwangju | Donggu | Korea, Republic of | 501-757 |
| 116 | Samsung Medical Center | Seoul | Gangnam-gu | Korea, Republic of | 06351 |
| 117 | Sejong General Hospital | Bucheon-si | Gyeonggi-do | Korea, Republic of | 14754 |
| 118 | Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | Korea, Republic of | 13620 |
| 119 | Pusan National University Yangsan Hospital | Yangsan | Gyeongsang | Korea, Republic of | 50612, |
| 120 | Severance Hospital, Yonsei University Health System | Seoul | Seodaemun-gu | Korea, Republic of | 120-752 |
| 121 | Inje University Busan Paik Hospital | Busan | Korea, Republic of | 47392 | |
| 122 | Keimyung University Dongsan Medical Center | Daegu | Korea, Republic of | 41931 | |
| 123 | Kyungpook National University Hospital | Daegu | Korea, Republic of | 41944 | |
| 124 | Korea University Anam Hospital | Seoul | Korea, Republic of | 02841 | |
| 125 | Seoul National University Hospital | Seoul | Korea, Republic of | 03080 | |
| 126 | The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | Korea, Republic of | 06591 | |
| 127 | Hospital Clínic de Barcelona | Barcelona | Spain | 08036 | |
| 128 | Hospital La Paz | Madrid | Spain | 28046 | |
| 129 | Hospital Donostia | San Sebastián | Spain | 20014 | |
| 130 | Royal Bournemouth Hospital | Bournemouth | Dorset | United Kingdom | BH7 7DW |
| 131 | Royal Stoke University Hospital | Stoke-on-Trent | Staffordshire | United Kingdom | ST4 6QG |
| 132 | Liverpool Heart and Chest - LHCH | Liverpool | United Kingdom | L14 3PE | |
| 133 | St. Bartholomew's Hospital | London | United Kingdom | EC1A 7BE | |
| 134 | King's College Hospital | London | United Kingdom | SE5 9RS |
Sponsors and Collaborators
- Boston Scientific Corporation
Investigators
- Principal Investigator: Claudio Schuger, M.D., University of Rochester Clincal Cardiovascular Research Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Boston Scientific Corporation
ClinicalTrials.gov Identifier:
NCT02923726
Other Study ID Numbers:
- C1924
First Posted:
Oct 5, 2016
Last Update Posted:
Aug 4, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Boston Scientific Corporation
Additional relevant MeSH terms: