Design and characteristics of the prophylactic intra-operative ventricular arrhythmia ablation in high-risk LVAD candidates (PIVATAL) trial
© 2023 The Authors. Annals of Noninvasive Electrocardiology published by Wiley Periodicals LLC..
BACKGROUND: The use of a Left Ventricular Assist Device (LVAD) in patients with advanced heart failure refractory to optimal medical management has progressed steadily over the past two decades. Data have demonstrated reduced LVAD efficacy, worse clinical outcome, and higher mortality for patients who experience significant ventricular tachyarrhythmia (VTA). We hypothesize that a novel prophylactic intra-operative VTA ablation protocol at the time of LVAD implantation may reduce the recurrent VTA and adverse events postimplant.
METHODS: We designed a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA in the previous 5 years. Enrolled patients will be randomized in a 1:1 fashion to intra-operative VTA ablation (n = 50) versus conventional medical management (n = 50) with LVAD implant. Arrhythmia outcomes data will be captured by an implantable cardioverter defibrillator (ICD) to monitor VTA events, with a uniform ICD programming protocol. Patients will be followed prospectively over a mean of 18 months (with a minimum of 9 months) after LVAD implantation to evaluate recurrent VTA, adverse events, and procedural outcomes. Secondary endpoints include right heart function/hemodynamics, healthcare utilization, and quality of life.
CONCLUSION: The primary aim of this first-ever randomized trial is to assess the efficacy of intra-operative ablation during LVAD surgery in reducing VTA recurrence and improving clinical outcomes for patients with a history of VTA.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:28 |
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| Enthalten in: |
Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc - 28(2023), 5 vom: 15. Sept., Seite e13073 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Huang, David T [VerfasserIn] |
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| Links: |
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| Themen: |
Ablation |
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| Anmerkungen: |
Date Completed 05.09.2023 Date Revised 06.09.2023 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1111/anec.13073 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
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| 100 | 1 | |a Huang, David T |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Design and characteristics of the prophylactic intra-operative ventricular arrhythmia ablation in high-risk LVAD candidates (PIVATAL) trial |
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| 500 | |a Date Revised 06.09.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023 The Authors. Annals of Noninvasive Electrocardiology published by Wiley Periodicals LLC. | ||
| 520 | |a BACKGROUND: The use of a Left Ventricular Assist Device (LVAD) in patients with advanced heart failure refractory to optimal medical management has progressed steadily over the past two decades. Data have demonstrated reduced LVAD efficacy, worse clinical outcome, and higher mortality for patients who experience significant ventricular tachyarrhythmia (VTA). We hypothesize that a novel prophylactic intra-operative VTA ablation protocol at the time of LVAD implantation may reduce the recurrent VTA and adverse events postimplant | ||
| 520 | |a METHODS: We designed a prospective, multicenter, open-label, randomized-controlled clinical trial enrolling 100 patients who are LVAD candidates with a history of VTA in the previous 5 years. Enrolled patients will be randomized in a 1:1 fashion to intra-operative VTA ablation (n = 50) versus conventional medical management (n = 50) with LVAD implant. Arrhythmia outcomes data will be captured by an implantable cardioverter defibrillator (ICD) to monitor VTA events, with a uniform ICD programming protocol. Patients will be followed prospectively over a mean of 18 months (with a minimum of 9 months) after LVAD implantation to evaluate recurrent VTA, adverse events, and procedural outcomes. Secondary endpoints include right heart function/hemodynamics, healthcare utilization, and quality of life | ||
| 520 | |a CONCLUSION: The primary aim of this first-ever randomized trial is to assess the efficacy of intra-operative ablation during LVAD surgery in reducing VTA recurrence and improving clinical outcomes for patients with a history of VTA | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Journal Article | |
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| 650 | 4 | |a left ventricular assist device | |
| 650 | 4 | |a ventricular tachycardia | |
| 700 | 1 | |a Gosev, Igor |e verfasserin |4 aut | |
| 700 | 1 | |a Wood, Katherine L |e verfasserin |4 aut | |
| 700 | 1 | |a Vidula, Hima |e verfasserin |4 aut | |
| 700 | 1 | |a Stevenson, William |e verfasserin |4 aut | |
| 700 | 1 | |a Marchlinski, Frank |e verfasserin |4 aut | |
| 700 | 1 | |a Supple, Gregory |e verfasserin |4 aut | |
| 700 | 1 | |a Zalawadiya, Sandip K |e verfasserin |4 aut | |
| 700 | 1 | |a Weiss, J Peter |e verfasserin |4 aut | |
| 700 | 1 | |a Tung, Roderick |e verfasserin |4 aut | |
| 700 | 1 | |a Tzou, Wendy S |e verfasserin |4 aut | |
| 700 | 1 | |a Moss, Joshua D |e verfasserin |4 aut | |
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| 700 | 1 | |a Sroubek, Jakub |e verfasserin |4 aut | |
| 700 | 1 | |a Soltesz, Edward |e verfasserin |4 aut | |
| 700 | 1 | |a Shivkumar, Kalyanam |e verfasserin |4 aut | |
| 700 | 1 | |a White, Casey |e verfasserin |4 aut | |
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