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| Name | Class |
|---|---|
| Baylis Medical Company | INDUSTRY |
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This will be a prospective single-blinded, randomized, controlled trial comparing the effectiveness and safety of transseptal puncture using the Baylis transseptal system to transseptal left atrial access with standard transseptal equipment (usual care) in patients undergoing catheter ablation procedures for atrial fibrillation with the cryoballoon system.
The targeted population will consist of patients with symptomatic paroxysmal atrial fibrillation undergoing pulmonary vein isolation with the cryoballoon system.
Study Objective - The objective of the prospective, randomized study is to evaluate the effectiveness and safety of the Baylis transseptal system (RF needle, TorFlex sheath, and specialised ProTrack guidewire) compared with a conventional transseptal (conventional sheath, Brockenbrough needle, and standard guidewire) for transseptal LA access during cryoballoon ablation procedures.
Trial design - This will be a prospective single-blinded, randomized, controlled trial comparing the effectiveness and safety of transseptal puncture using the Baylis transseptal system to transseptal left atrial access with standard transseptal equipment (usual care) in patients undergoing catheter ablation procedures for atrial fibrillation with the cryoballoon system.
Study Population - The targeted population will consist of patients with symptomatic paroxysmal atrial fibrillation undergoing pulmonary vein isolation with the cryoballoon system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baylis transseptal system group | Active Comparator | Patients randomized to the Baylis transseptal system group (Bayliss Group) will undergo transseptal puncture with a large, preformed curve 71-cm-C1 or 98-cm-C1 18-gauge NRG needle (Baylis Medical) through a TorFlex sheath (Baylis Medical), with the sheath curve selected at the discretion of the operating physician. |
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| Conventional transseptal group | Active Comparator | Patients randomized to the conventional transseptal group (Standard Group) will undergo transseptal puncture with either a large, preformed curve 71- or 98-cm 18-gauge BRK needle (BRK, BRK-1, BRK-2 needle, St. Jude Medical) through any non-Baylis sheath (for example Schwartz SL, Biosense-Webster Preface) selected at the discretion of the operating physician. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baylis transseptal system group | Device |
| ||
| Standard conventional transseptal group |
| Measure | Description | Time Frame |
|---|---|---|
| Total time required for left atrial access | defined as time from the first pull-down of the needle/sheath/dilator apparatus in the superior vena cava to first entrance of the cryoballoon into the left atrium. | Intraprocedural assessment (within 24 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Transeptal Access | Success/failure of the assigned transseptal apparatus to achieve transeptal puncture (proportion of patients necessitating the use of the alternate study apparatus - e.g. cross-over from the NRG RF needle to the to conventional BRK needle) | Intraprocedural assessment (within 24 hours) |
| Plastic Shavings |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital | Vancouver | British Columbia | Canada | |||
| Vancouver General Hospital, University of British Columbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35739438 | Derived | Andrade JG, Macle L, Bennett MT, Hawkins NM, Essebag V, Champagne J, Roux JF, Makanjee B, Tang A, Skanes A, Khaykin Y, Morillo C, Jolly U, Lockwood E, Amit G, Angaran P, Sapp J, Wardell S, Wells GA, Verma A, Deyell MW. Randomized trial of conventional versus radiofrequency needle transseptal puncture for cryoballoon ablation: the CRYO-LATS trial. J Interv Card Electrophysiol. 2022 Nov;65(2):481-489. doi: 10.1007/s10840-022-01277-y. Epub 2022 Jun 24. |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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150 patients will be randomized in a 1:1, single-blinded fashion to 1 of 2 transseptal groups.
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| Device |
|
Proportion of cases whereby the presence (or absence) of visible plastic dilator shavings from needle introduction are seen |
| Intraprocedural assessment of visible plastic shavings (within 24 hours) |
| The proportion of patients sustaining a procedural complication plausibly related to transseptal puncture | Events include pericardial effusion, pericardial tamponade, cardiac perforation, air embolism, aortic root puncture | Acute peri-procedural complications will be defined as occurring within 30 days of ablation |
| Transseptal time - septal engagement to sheath advancement | Time from inter-atrial septum engagement with the transseptal needle to FlexCath sheath advancement into the LA | Intraprocedural assessment (measured in seconds) |
| Transseptal time - left atrial access to sheath positioning | Time from needle advancement through the septum to sheath advancement into the LA | Intraprocedural assessment (measured in seconds) |
| Vancouver |
| British Columbia |
| Canada |
| Queen Elizabeth II | Halifax | Nova Scotia | Canada |
| Southlake Regional Health Centre | Newmarket | Ontario | Canada |
| Université Laval | Québec | Quebec | Canada |
| University of Saskatchewan | Saskatoon | Saskatchewan | Canada |
| D013568 |
| Pathological Conditions, Signs and Symptoms |