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Efficacy and safety of novel temperature-controlled radiofrequency ablation system during pulmonary vein isolation in patients with paroxysmal atrial fibrillation: TRAC-AF study
Z. Starek, F. Lehar, J. Jez, M. Pesl, P. Neuzil, L. Sediva, J. Petru, L. Dujka, M. Funasako, J. Kautzner, P. Peichl, B. Aldhoon, JP. Albenque, S. Combes, S. Boveda, SR. Dukkipati, VY. Reddy
Language English Country Netherlands
Document type Clinical Trial, Journal Article, Multicenter Study
NLK
ProQuest Central
from 1997-07-01 to 1 year ago
Medline Complete (EBSCOhost)
from 2011-01-01 to 1 year ago
Health & Medicine (ProQuest)
from 1997-07-01 to 1 year ago
- MeSH
- Equipment Design MeSH
- Atrial Fibrillation * MeSH
- Catheter Ablation * adverse effects MeSH
- Middle Aged MeSH
- Humans MeSH
- Prospective Studies MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Temperature MeSH
- Pulmonary Veins * surgery MeSH
- Treatment Outcome MeSH
- Check Tag
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial MeSH
- Multicenter Study MeSH
BACKGROUND AND PURPOSE: Saline-irrigated radiofrequency ablation (RFA) for atrial fibrillation (AF) is limited by the absence of reliable thermal feedback limiting the utility of temperature monitoring for power titration. The DiamondTemp (DT) ablation catheter was designed to allow efficient temperature-controlled irrigated ablation. We sought to assess the 1-year clinical safety and efficacy of the DT catheter in treating drug-refractory paroxysmal AF. METHODS: The TRAC-AF trial (NCT02821351) is a prospective, multi-center (n = 4), single-arm study which enrolled patients with symptomatic, drug-refractory, paroxysmal AF. Using the DT catheter, point-by-point ablation was performed around all pulmonary veins (PVs) to achieve PV isolation (PVI). Ablation was performed in a temperature-controlled mode (60 °C, max 50 W). Acute and chronic efficacy and safety was evaluated. RESULTS: Seventy-one patients (age 69.9 ± 11.0 years; 60.6% male) were ablated using the DT catheter. The mean fluoroscopy and RF ablation times were 9.3 ± 6.1 min and 20.6 ± 8.9 min, respectively. Acute isolation of all PVs was achieved in 100% of patients, and freedom from AF after 1 year was 70.6%. There were no steam pops, char, or coagulum on the catheter tip after ablation. There were few serious procedure/device-related adverse events including a single case of cardiac tamponade (1.4%) and transient ischemic attack (1.4). CONCLUSION: This first in man series demonstrates that temperature-controlled irrigated RFA with the DT catheter is efficient, safe, and effective in the treatment of paroxysmal AF. Randomized controlled trials are ongoing and will evaluate better the role of this catheter in relation to standard RFA. TRIAL REGISTRATION: Registered on the site ClinicalTrials.gov January 2016 with identifier: NCT02821351.
Department of Cardiology Na Homolce Hospital Roentgenova 2 15030 Prague Czech Republic
Department of Medicine 1 Palacky University Hospital Olomouc Czech Republic
Universiteit Ziekenhuis Vrije Universiteit Brussel Laarbeeklaan 101 1090 Jette Brussels Belgium
References provided by Crossref.org
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- $a Starek, Zdenek $u International Clinical Research Center, Interventional cardiac electrophysiology group, St. Anne's University Hospital Brno, Pekařská 53, 656 91, Brno, Czech Republic. zdenek.starek@fnusa.cz $u First Department of Internal Medicine/Cardioangiology, St. Anne's Hospital, Masaryk University, Pekařská 53, 656 91, Brno, Czech Republic. zdenek.starek@fnusa.cz $1 https://orcid.org/http://orcid.org/0000000295101386
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- $a BACKGROUND AND PURPOSE: Saline-irrigated radiofrequency ablation (RFA) for atrial fibrillation (AF) is limited by the absence of reliable thermal feedback limiting the utility of temperature monitoring for power titration. The DiamondTemp (DT) ablation catheter was designed to allow efficient temperature-controlled irrigated ablation. We sought to assess the 1-year clinical safety and efficacy of the DT catheter in treating drug-refractory paroxysmal AF. METHODS: The TRAC-AF trial (NCT02821351) is a prospective, multi-center (n = 4), single-arm study which enrolled patients with symptomatic, drug-refractory, paroxysmal AF. Using the DT catheter, point-by-point ablation was performed around all pulmonary veins (PVs) to achieve PV isolation (PVI). Ablation was performed in a temperature-controlled mode (60 °C, max 50 W). Acute and chronic efficacy and safety was evaluated. RESULTS: Seventy-one patients (age 69.9 ± 11.0 years; 60.6% male) were ablated using the DT catheter. The mean fluoroscopy and RF ablation times were 9.3 ± 6.1 min and 20.6 ± 8.9 min, respectively. Acute isolation of all PVs was achieved in 100% of patients, and freedom from AF after 1 year was 70.6%. There were no steam pops, char, or coagulum on the catheter tip after ablation. There were few serious procedure/device-related adverse events including a single case of cardiac tamponade (1.4%) and transient ischemic attack (1.4). CONCLUSION: This first in man series demonstrates that temperature-controlled irrigated RFA with the DT catheter is efficient, safe, and effective in the treatment of paroxysmal AF. Randomized controlled trials are ongoing and will evaluate better the role of this catheter in relation to standard RFA. TRIAL REGISTRATION: Registered on the site ClinicalTrials.gov January 2016 with identifier: NCT02821351.
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