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This is a prospective, multi-center, global, single-arm, pivotal investigational study designed to evaluate the safety and effectiveness of the CSP ICD Lead in a subject population indicated for ICD or CRT-D therapy.
The clinical investigation will enroll up to 414 subjects at up to 70 participating centers from the United States, Canada, Europe, and Asia Pacific.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | Subjects undergoing ICD/CRT implant will be implanted with the CSP ICD Lead in the LBBAP location and undergo required electrical testing |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LBBAP Implant with a CSP ICD Lead | Device | Required electrical testing for pacing, sensing, impedance and defibrillation will be completed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Primary Safety Endpoint | Freedom from CSP ICD Lead-related Serious Adverse Device Effects (SADEs) through 3 months post-implant for subjects in which the CSP ICD Lead implant was attempted | 3 months post-implant |
| Primary Effectiveness Endpoint 1 | 3-month composite success rate of acceptable pacing capture thresholds and R-wave sense amplitudes of the CSP ICD Leads in the subjects with the CSP ICD Lead implanted at the LBBA | 3-months post-implant |
| Primary Effectiveness Endpoint 2 | Success rate of the defibrillation testing at implant in the subjects who complete the defibrillation test with the CSP ICD Lead implanted at the LBBA | at implant |
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Inclusion Criteria:
Subject must meet current clinical practice guidelines for implantation of ICD or CRT-D and will undergo one of the following:
Subject is ≥ 18 years of age or age of legal consent, whichever age is greater.
Subject is willing to undergo implant defibrillation testing if requested. Subjects with AF in whom defibrillation testing is required must have been on or willing to be on uninterrupted anticoagulation therapy before, during, and after the implant procedure.
Subject is willing to comply with clinical investigation procedures and agrees to return to clinic for all required follow-up visits, tests, and exams.
Subject has been informed of the nature of the clinical investigation, agrees to its provisions and has provided a signed written informed consent, approved by the IRB/EC.
Exclusion Criteria:
Defibrillation testing exclusion criteria (these are part of general exclusion criteria when defibrillation testing is requested):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heart Center Research LLC | Huntsville | Alabama | 35801 | United States | ||
| Banner University Medical Center Phoenix |
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| Phoenix |
| Arizona |
| 85006 |
| United States |
| Arrhythmia Research Group | Jonesboro | Arkansas | 72401 | United States |
| Premier Cardiology, Inc. | Newport Beach | California | 92663 | United States |
| University of California at San Diego (UCSD) Medical Center | San Diego | California | 92103 | United States |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| AdventHealth Orlando | Orlando | Florida | 32803 | United States |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| New York Presbyterian Hospital/Cornell University | New York | New York | 10021 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | United States |
| Lancaster General Hospital | Lancaster | Pennsylvania | 17602 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Erlanger Medical Center | Chattanooga | Tennessee | 37403 | United States |
| Medical City Dallas Hospital | Dallas | Texas | 75230 | United States |
| Sentara Norfolk General Hospital | Norfolk | Virginia | 23507 | United States |
| The Prince Charles Hospital | Chermside | Queensland | Australia |
| Princess Alexandra Hospital | Woolloongabba | Queensland | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | Australia |
| Monash Health | Clayton | Victoria | Australia |
| MUHC- Montreal General Hospital | Montreal | H3G 1A4 | Canada |
| CHRU Hopital de Pontchaillou | Rennes | Brittan | 35033 | France |
| CHU Trousseau | Chambray-lès-Tours | Centre-Val de Loire | 37170 | France |
| Hôpital Pitié Salpetrière | Paris | Ile | 75013 | France |
| Prince of Wales Hospital | Hong Kong | Hong Kong |
| Queen Mary Hospital | Hong Kong | Hong Kong |
| Max Super Specialty Hospital | New Delhi | National Capital Territory of Delhi | 110017 | India |
| Sree Chitra Tirunal Institute for Medical Sciences & tech. | Trivandrum | New Delhi | 695-011 | India |
| Velammal Medical College Hospital | Madurai | Tmlnadu | 625009 | India |
| Ospedale S.S. Annunziata | Taranto | Apulia | 74100 | Italy |
| ASST Grande Ospedale Metropolitano Niguarda | Milan | Lombard | 20162 | Italy |
| National Heart Centre Singapore | Singapore | 169609 | Singapore |
| Changi General Hospital | Singapore | Singapore |
| Tan Tock Seng Hospital | Singapore | Singapore |
| Hospital Universitario Virgen de las Nieves | Granada | 18014 | Spain |
| Hospital Universitari i Politècnic La Fe | Valencia | 46026 | Spain |
| Hôpitaux Universitaires de Genève | Geneva | 1205 | Switzerland |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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