MARC details
| 000 -LEADER |
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| fixed length control field |
03842nam a22005177a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
201229s20212021 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
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| International Standard Serial Number |
1383-875X |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
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| PMID |
33009645 |
| 245 ## - TITLE STATEMENT |
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| Title |
Left atrial posterior wall isolation in conjunction with pulmonary vein isolation using cryoballoon for treatment of persistent atrial fibrillation (PIVoTAL): study rationale and design. |
| 251 ## - Source |
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| Source |
Journal of Interventional Cardiac Electrophysiology. 62(1):187-198, 2021 Oct. |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
J Interv Card Electrophysiol. 62(1):187-198, 2021 Oct. |
| 252 ## - Abbreviated Source |
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| Former abbreviated source |
J Interv Card Electrophysiol. 2020 Oct 03 |
| 253 ## - Journal Name |
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| Journal name |
Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Year |
2021 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
|---|
| Manufacturer |
FY2022 |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Publication status |
aheadofprint |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Publication status |
ppublish |
| 266 ## - Date added to catalog |
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| Date added to catalog |
2020-12-29 |
| 268 ## - Previous citation |
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| -- |
Journal of Interventional Cardiac Electrophysiology. 2020 Oct 03 |
| 269 ## - Original dates |
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| Original fiscal year |
FY2021 |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
BACKGROUND: There is growing evidence in support of pulmonary vein isolation (PVI) with concomitant posterior wall isolation (PWI) for the treatment of patients with symptomatic persistent atrial fibrillation (persAF). However, there is limited data on the safety and efficacy of this approach using the cryoballoon. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
CONCLUSION: The PIVoTAL is a prospective, randomized controlled trial designed to evaluate the outcomes of PVI alone versus PVI+PWI using the cryoballoon, in patients with symptomatic persAF. We hypothesize that PVI+PWI will prove to be superior to PVI alone for prevention of AF recurrence. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
METHODS: The PIVoTAL is a prospective, randomized controlled study ( ClinicalTrials.gov : NCT04505163) in which patients with symptomatic persAF refractory/intolerant to >= 1 class I-IV antiarrhythmic drug, undergoing first-time catheter ablation, will be randomized to PVI (n = 183) versus PVI+PWI (n = 183) using the cryoballoon in a 1:1 fashion. The design will be double-blind until randomization immediately after PVI, beyond which the design will transform into a single-blind. PVI using cryoballoon will be standardized using a pre-specified dosing algorithm. Other empiric ablations aside from documented arrhythmias/arrhythmias spontaneously induced during the procedure will not be permitted. The primary efficacy endpoint is defined as AF recurrence at 12 months, after a single procedure and a 90-day blanking period. Arrhythmia outcomes will be assessed by routine electrocardiograms and 7-14 day ambulatory electrocardiographic monitoring at 3, 6, and 12 months post-ablation. |
| 520 ## - SUMMARY, ETC. |
|---|
| Abstract |
OBJECTIVE: The aim of this multicenter, investigational device exemption trial (G190171) is to prospectively evaluate the acute and long-term outcomes of PVI versus PVI+PWI using the cryoballoon in patients with symptomatic persAF. |
| 546 ## - LANGUAGE NOTE |
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| Language note |
English |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Atrial Fibrillation |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Catheter Ablation |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Cryosurgery |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Pulmonary Veins |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Atrial Fibrillation/dg [Diagnostic Imaging] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Atrial Fibrillation/su [Surgery] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Humans |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Prospective Studies |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Pulmonary Veins/dg [Diagnostic Imaging] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Pulmonary Veins/su [Surgery] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Recurrence |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Single-Blind Method |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Treatment Outcome |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
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| Institution |
MedStar Heart & Vascular Institute |
| 657 ## - INDEX TERM--FUNCTION |
|---|
| Medline publication type |
Journal Article |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Lee, Sung |
| 790 ## - Authors |
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| All authors |
Al-Ahmad A, Allen SL, Aryana A, Baker JH, Baykaner T, Buch EF, d'Avila A, Di Biase L, Ellis E, Espinosa MA, Kowalski M, Lee S, Makati K, Natale A, Okishige K, Pujara DK, Srivatsa U, Tadros T |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="https://dx.doi.org/10.1007/s10840-020-00885-w">https://dx.doi.org/10.1007/s10840-020-00885-w</a> |
| Public note |
https://dx.doi.org/10.1007/s10840-020-00885-w |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Koha item type |
Journal Article |
| Item type description |
Article |
