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The purpose of the study is to assess lead implant success and complication rate using the Medtronic Attain Family of left-heart leads and delivery catheters.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Attain Success Lead | Device | Attain Success Lead |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects Successfully Implanted With an Attain Family Left-heart Lead Using an Attain Family Delivery Catheter | Implant success was defined as final successful placement of the Attain Family left-heart lead in the coronary vein branches utilizing the Attain Family of delivery catheters. | Implant |
| Subjects Without a Left-heart Lead and Delivery Catheter Related Complication | A left-heart lead and delivery related complication was defined as a complication, an adverse event that resulted in death, any termination of significant device function or invasive intervention, that resulted from the presence of or performance (intended or otherwise) of the Medtronic left-heart lead or Attain Family of delivery catheters. All adverse events were adjudicated by an Adverse Event Advisory Committee (AEAC). | Implant to 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patient referral to a participating study center with practitioners experienced in handling and implantation of the cardiac resynchronization therapy (CRT) device, the left-heart lead, and the use of the delivery catheter.
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| Name | Affiliation | Role |
|---|---|---|
| John D Hummel, MD | Davis Heart & Lung Research Institute, The Ohio State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Little Rock | Arkansas | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Attain Family Left Heart Lead | Subjects who underwent an Attain Family lead implant after either an Attain Family catheter attempt or any catheter model attempt |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Downey |
| California |
| United States |
| Modesto | California | United States |
| Redding | California | United States |
| Riverside | California | United States |
| San Diego | California | United States |
| San Jose | California | United States |
| Santa Rosa | California | United States |
| Danbury | Connecticut | United States |
| Washington D.C. | District of Columbia | United States |
| Delray Beach | Florida | United States |
| Lake Mary | Florida | United States |
| Naples | Florida | United States |
| Orlando | Florida | United States |
| Panama City | Florida | United States |
| Saint Augustine | Florida | United States |
| Tampa | Florida | United States |
| Athens | Georgia | United States |
| Atlanta | Georgia | United States |
| Macon | Georgia | United States |
| Marietta | Georgia | United States |
| Chicago | Illinois | United States |
| Decatur | Illinois | United States |
| Indianapolis | Indiana | United States |
| Newburgh | Indiana | United States |
| Overland Park | Kansas | United States |
| Bowling Green | Kentucky | United States |
| Lexington | Kentucky | United States |
| Houma | Louisiana | United States |
| Baltimore | Maryland | United States |
| Takoma Park | Maryland | United States |
| Boston | Massachusetts | United States |
| Muskegon | Michigan | United States |
| Royal Oak | Michigan | United States |
| Saint Clair Shore | Michigan | United States |
| Ypsilanti | Michigan | United States |
| Minneapolis | Minnesota | United States |
| St Louis | Missouri | United States |
| Washington | Missouri | United States |
| Omaha | Nebraska | United States |
| Concord | New Hampshire | United States |
| Englewood | New Jersey | United States |
| Huntington | New York | United States |
| Asheville | North Carolina | United States |
| Concord | North Carolina | United States |
| Fargo | North Dakota | United States |
| Cleveland | Ohio | United States |
| Columbus | Ohio | United States |
| Kettering | Ohio | United States |
| Abington | Pennsylvania | United States |
| Bethlehem | Pennsylvania | United States |
| Erie | Pennsylvania | United States |
| Harrisburg | Pennsylvania | United States |
| Wormleysburg | Pennsylvania | United States |
| Florence | South Carolina | United States |
| Germantown | Tennessee | United States |
| Knoxsville | Tennessee | United States |
| Nashville | Tennessee | United States |
| Amarillo | Texas | United States |
| Austin | Texas | United States |
| Brownsville | Texas | United States |
| Dallas | Texas | United States |
| Fort Worth | Texas | United States |
| Houston | Texas | United States |
| Longview | Texas | United States |
| The Woodlands | Texas | United States |
| Murray | Utah | United States |
| Salt Lake City | Utah | United States |
| Frederickburg | Virginia | United States |
| Bellingham | Washington | United States |
| Spokane | Washington | United States |
| Green Bay | Wisconsin | United States |
| Ontario | Canada |
| Jiangsu | China |
| Sichuan | China |
| Xinjian | China |
| Amiens | France |
| Anglouleme | France |
| Bayonne | France |
| Bordeaux | France |
| Clermont-Ferrand | France |
| Créteil | France |
| Metz-Tessy | France |
| Montfermeil | France |
| Nice | France |
| Orléans | France |
| Paris | France |
| Poitiers | France |
| Villingen | Germany |
| Shatin | Hong Kong |
| Haryāna | India |
| New Dehli | India |
| New Delhi | India |
| Rajasthan | India |
| Vizag | India |
| Kuala Lumpur | Malaysia |
| Tal-Qroqq | Malta |
| Lahore | Pakistan |
| Bydgoszcz | Poland |
| Krakow | Poland |
| Zabreze | Poland |
| San Juan | Puerto Rico |
| Brasov | Romania |
| Bucharest | Romania |
| Novena | Singapore |
| Taichung | Taiwan |
| Taipei | Taiwan |
| Bangkok | Thailand |
| Attain Family Study System Attempt |
|
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Attain Family Lead | Subjects who underwent an Attain Family lead implant after either an Attain Family catheter attempt or any catheter model attempt |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | Subjects Successfully Implanted With an Attain Family Left-heart Lead Using an Attain Family Delivery Catheter | Implant success was defined as final successful placement of the Attain Family left-heart lead in the coronary vein branches utilizing the Attain Family of delivery catheters. | Posted | Number | participants | Implant |
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| Primary | Subjects Without a Left-heart Lead and Delivery Catheter Related Complication | A left-heart lead and delivery related complication was defined as a complication, an adverse event that resulted in death, any termination of significant device function or invasive intervention, that resulted from the presence of or performance (intended or otherwise) of the Medtronic left-heart lead or Attain Family of delivery catheters. All adverse events were adjudicated by an Adverse Event Advisory Committee (AEAC). | Posted | Number | participants | Implant to 3 months |
|
|
Implant to 3 month visit.
All new and/or worsening adverse events related to the left heart leads and left heart delivery catheters were collected through the 3 month visit. Event collection began when the subject was enrolled in the study and underwent a left-heart lead implant attempt.
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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 | Attain Family Lead | All new and/or worsening adverse events related to the left-heart leads and left-heart lead delivery catheters were collected through the 3 month visit. Event collection started once the subject enrolled in the study and underwent a left-heart lead implant attempt. | 55 | 2,014 | 0 | 2,014 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest | Cardiac disorders | MedDRA |
| ||
| Cardiac tamponade | Cardiac disorders | MedDRA |
| ||
| Deep vein thrombosis | Vascular disorders | MedDRA |
| ||
| Device capturing issue | Injury, poisoning and procedural complications | MedDRA |
| ||
| Device connection issue | Injury, poisoning and procedural complications | MedDRA |
| ||
| Device dislocation | Injury, poisoning and procedural complications | MedDRA |
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| Device pacing issue | Injury, poisoning and procedural complications | MedDRA |
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| Device stimulation issue | Injury, poisoning and procedural complications | MedDRA |
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| Haemothorax | Respiratory, thoracic and mediastinal disorders | MedDRA |
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| Implant site infection | Infections and infestations | MedDRA |
| ||
| Implant site irritation | Injury, poisoning and procedural complications | MedDRA |
| ||
| Pericardial haemorrhage | Cardiac disorders | MedDRA |
| ||
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA |
| ||
| Sudden cardiac death | Cardiac disorders | MedDRA |
| ||
| Ventricular tachycardia | Cardiac disorders | MedDRA |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Attain Success Clinical Trial Leader | Medtronic, Inc. | 800-328-2518 | 62864 | medtronicCRMtrials@medtronic.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Hong Kong |
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| Pakistan |
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| Thailand |
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| Malta |
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| India |
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| France |
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| Canada |
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| Puerto Rico |
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| Malaysia |
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| Poland |
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| Singapore |
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| Romania |
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| Germany |
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| China |
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