Personalized Atrial Fibrillation Ablation With QDOT

NCT04298177 | Unknown Phase 4 DMC FDA Device

• 1 other identifier: QDOT-by-LAW
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Circumferential pulmonary vein isolation (PVI) has become a mainstay in the treatment of atrial fibrillation (AF), particularly in symptomatic patients with paroxysmal AF (PAF) intolerant or refractory to medical treatment. The safety and short-term performance of the novel QDOT® catheter (Biosense Webster, Irvine, CA, USA), that allows for a high-power short-duration (HPSD) ablation, has already been evaluated in the QDOT-FAST clinical study, with favorable data on feasibility and safety, and lowered fluoroscopy and procedure times needed to achieve complete PVI. HPSD ablation was based on immediate heat formation during the resistive phase, affecting a small tissue depth at 90 W/4 s (irrigation at 8 ml/min) with a temperature limit of 65ºC. However, up to date there are no randomized studies evaluating the real usefulness of the QDOT® catheter. Longer-term follow-up is still required to verify the long-term effectiveness and correlations between short-term follow-up and arrhythmia recurrence when using this catheter. The impact of this novel catheter, when used in conjunction with a personalized ablation protocol that uses the information of left atrial wall thickness (LAWT) to modulate the AI target at each ablation point, compared with a standard ablation protocol following the published CLOSE study criteria is already unknown.

Conditions

Atrial Fibrillation

Keywords

atrial fibrillation; catheter ablation; pulmonary vein isolation; left atrial wall thickness; high-power short-duration ablation; QDOT

Outcome Measures

Primary Outcomes (1)

• Clinical efficacy

  Survival free of any atrial arrhythmia at the 3-month, 6-month, and 12-month follow-up.

  1 year

Secondary Outcomes (7)

• Procedure time

  1 month

• Radiofrequency time

  1 month

• Number of radiofrequency applications

  1 month

• Fluoroscopy time

  1 month

• First pass isolation rate

  1 month

Study Arms (2)

QDOT-LAWT

EXPERIMENTAL

A QDOT® 3.5-mm open-irrigated contact force-sensing RF ablation catheter (Biosense Webster, Inc., Irvine, CA, USA) will be used. The primary ablation mode for PVI will depend on the calculated LAWT at each atrial point, as follows: \*\*\< 3.5-mm LAWT (red, and yellow colors): vHPSD ablation will be performed. If \<1-mm LAWT (red color): Power 90 W; the duration of RF applications will be reduced to 2 seconds. If 1-3.5 mm LAWT (yellow color): Power 90 W; the duration of RF applications will be 4 seconds, according to the QDOT-FAST protocol. \*\*\> 3.5-mm LAWT (green color): QMODE ablation will be performed. 50 W with AI target = 500

Device: Atrial fibrillation ablation using the QDOT® catheter

CLOSE

ACTIVE COMPARATOR

In the CLOSE arm, the use of MDCT-derived LAWT information will not be available for the operator. A ThermoCool® SmartTouch® 3.5-mm open-irrigated contact force-sensing RF ablation catheter (Biosense Webster, Inc., Diamond Bar, CA, USA) will be used. The ablation will be performed using a proprietary RF generator (SMARTABLATE®; Biosense Webster, Diamond Bar, CA, USA). Ablation will be performed according to the CLOSE study settings: Power-controlled mode (without ramping) with 25 to 35 W (irrigation flow 30 ml/min). RF will be delivered until an AI of ≥ 400 at the posterior wall/roof and ≥ 550 at the anterior wall are reached.

Procedure: Standard atrial fibrillation ablation

Interventions

Atrial fibrillation ablation using the QDOT® catheter DEVICE

Atrial fibrillation ablation will be performed using the QDOT® catheter. The ablation mode will be selected according to the MDCT-derived LAWT information.

Also known as: Pulmonary vein isolation

QDOT-LAWT

Standard atrial fibrillation ablation PROCEDURE

Atrial fibrillation ablation will be performed using the SmartTouch® catheter. The ablation parameters will be adjusted according to the settings previously described in the CLOSE study.

Also known as: Pulmonary vein isolation

CLOSE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years.
• Indication for paroxysmal atrial fibrillation ablation.
• Signed informed consent

You may not qualify if:

• Age \< 18 years.
• Pregnancy.
• Previous AF redo procedure.
• Impossibility to perform a pre-procedural CT scan.
• Concomitant investigation treatments.
• Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.

Sponsors & Collaborators

• Antonio Berruezo, MD, PhD: lead

Study Sites (1)

Teknon Medical Center

Barcelona, 08004, Spain

RECRUITING

Related Publications (16)

• Calkins H, Hindricks G, Cappato R, Kim YH, Saad EB, Aguinaga L, Akar JG, Badhwar V, Brugada J, Camm J, Chen PS, Chen SA, Chung MK, Nielsen JC, Curtis AB, Davies DW, Day JD, d'Avila A, de Groot NMSN, Di Biase L, Duytschaever M, Edgerton JR, Ellenbogen KA, Ellinor PT, Ernst S, Fenelon G, Gerstenfeld EP, Haines DE, Haissaguerre M, Helm RH, Hylek E, Jackman WM, Jalife J, Kalman JM, Kautzner J, Kottkamp H, Kuck KH, Kumagai K, Lee R, Lewalter T, Lindsay BD, Macle L, Mansour M, Marchlinski FE, Michaud GF, Nakagawa H, Natale A, Nattel S, Okumura K, Packer D, Pokushalov E, Reynolds MR, Sanders P, Scanavacca M, Schilling R, Tondo C, Tsao HM, Verma A, Wilber DJ, Yamane T. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation: Executive summary. J Arrhythm. 2017 Oct;33(5):369-409. doi: 10.1016/j.joa.2017.08.001. Epub 2017 Sep 15. No abstract available.

  PMID: 29021841 BACKGROUND

• Ouyang F, Tilz R, Chun J, Schmidt B, Wissner E, Zerm T, Neven K, Kokturk B, Konstantinidou M, Metzner A, Fuernkranz A, Kuck KH. Long-term results of catheter ablation in paroxysmal atrial fibrillation: lessons from a 5-year follow-up. Circulation. 2010 Dec 7;122(23):2368-77. doi: 10.1161/CIRCULATIONAHA.110.946806. Epub 2010 Nov 22.

  PMID: 21098450 BACKGROUND

• Cappato R, Negroni S, Pecora D, Bentivegna S, Lupo PP, Carolei A, Esposito C, Furlanello F, De Ambroggi L. Prospective assessment of late conduction recurrence across radiofrequency lesions producing electrical disconnection at the pulmonary vein ostium in patients with atrial fibrillation. Circulation. 2003 Sep 30;108(13):1599-604. doi: 10.1161/01.CIR.0000091081.19465.F1. Epub 2003 Sep 8.

  PMID: 12963643 BACKGROUND

• Kuck KH, Hoffmann BA, Ernst S, Wegscheider K, Treszl A, Metzner A, Eckardt L, Lewalter T, Breithardt G, Willems S; Gap-AF-AFNET 1 Investigators*. Impact of Complete Versus Incomplete Circumferential Lines Around the Pulmonary Veins During Catheter Ablation of Paroxysmal Atrial Fibrillation: Results From the Gap-Atrial Fibrillation-German Atrial Fibrillation Competence Network 1 Trial. Circ Arrhythm Electrophysiol. 2016 Jan;9(1):e003337. doi: 10.1161/CIRCEP.115.003337.

  PMID: 26763226 BACKGROUND

• Natale A, Reddy VY, Monir G, Wilber DJ, Lindsay BD, McElderry HT, Kantipudi C, Mansour MC, Melby DP, Packer DL, Nakagawa H, Zhang B, Stagg RB, Boo LM, Marchlinski FE. Paroxysmal AF catheter ablation with a contact force sensing catheter: results of the prospective, multicenter SMART-AF trial. J Am Coll Cardiol. 2014 Aug 19;64(7):647-56. doi: 10.1016/j.jacc.2014.04.072.

  PMID: 25125294 BACKGROUND

• Reddy VY, Dukkipati SR, Neuzil P, Natale A, Albenque JP, Kautzner J, Shah D, Michaud G, Wharton M, Harari D, Mahapatra S, Lambert H, Mansour M. Randomized, Controlled Trial of the Safety and Effectiveness of a Contact Force-Sensing Irrigated Catheter for Ablation of Paroxysmal Atrial Fibrillation: Results of the TactiCath Contact Force Ablation Catheter Study for Atrial Fibrillation (TOCCASTAR) Study. Circulation. 2015 Sep 8;132(10):907-15. doi: 10.1161/CIRCULATIONAHA.114.014092. Epub 2015 Aug 10.

  PMID: 26260733 BACKGROUND

• Reddy VY, Pollak S, Lindsay BD, McElderry HT, Natale A, Kantipudi C, Mansour M, Melby DP, Lakkireddy D, Levy T, Izraeli D, Sangli C, Wilber D. Relationship Between Catheter Stability and 12-Month Success After Pulmonary Vein Isolation: A Subanalysis of the SMART-AF Trial. JACC Clin Electrophysiol. 2016 Nov;2(6):691-699. doi: 10.1016/j.jacep.2016.07.014. Epub 2016 Nov 21.

  PMID: 29759747 BACKGROUND

• Das M, Loveday JJ, Wynn GJ, Gomes S, Saeed Y, Bonnett LJ, Waktare JEP, Todd DM, Hall MCS, Snowdon RL, Modi S, Gupta D. Ablation index, a novel marker of ablation lesion quality: prediction of pulmonary vein reconnection at repeat electrophysiology study and regional differences in target values. Europace. 2017 May 1;19(5):775-783. doi: 10.1093/europace/euw105.

  PMID: 27247002 BACKGROUND

• El Haddad M, Taghji P, Phlips T, Wolf M, Demolder A, Choudhury R, Knecht S, Vandekerckhove Y, Tavernier R, Nakagawa H, Duytschaever M. Determinants of Acute and Late Pulmonary Vein Reconnection in Contact Force-Guided Pulmonary Vein Isolation: Identifying the Weakest Link in the Ablation Chain. Circ Arrhythm Electrophysiol. 2017 Apr;10(4):e004867. doi: 10.1161/CIRCEP.116.004867.

  PMID: 28381417 BACKGROUND

• Taghji P, El Haddad M, Phlips T, Wolf M, Knecht S, Vandekerckhove Y, Tavernier R, Nakagawa H, Duytschaever M. Evaluation of a Strategy Aiming to Enclose the Pulmonary Veins With Contiguous and Optimized Radiofrequency Lesions in Paroxysmal Atrial Fibrillation: A Pilot Study. JACC Clin Electrophysiol. 2018 Jan;4(1):99-108. doi: 10.1016/j.jacep.2017.06.023. Epub 2017 Sep 27.

  PMID: 29600792 BACKGROUND

• Kawaji T, Hojo S, Kushiyama A, Nakatsuma K, Kaneda K, Kato M, Yokomatsu T, Miki S. Limitations of lesion quality estimated by ablation index: An in vitro study. J Cardiovasc Electrophysiol. 2019 Jun;30(6):926-933. doi: 10.1111/jce.13928. Epub 2019 Apr 2.

  PMID: 30912209 BACKGROUND

• Bourier F, Duchateau J, Vlachos K, Lam A, Martin CA, Takigawa M, Kitamura T, Frontera A, Cheniti G, Pambrun T, Klotz N, Denis A, Derval N, Cochet H, Sacher F, Hocini M, Haissaguerre M, Jais P. High-power short-duration versus standard radiofrequency ablation: Insights on lesion metrics. J Cardiovasc Electrophysiol. 2018 Nov;29(11):1570-1575. doi: 10.1111/jce.13724. Epub 2018 Sep 25.

  PMID: 30168230 BACKGROUND

• Leshem E, Zilberman I, Tschabrunn CM, Barkagan M, Contreras-Valdes FM, Govari A, Anter E. High-Power and Short-Duration Ablation for Pulmonary Vein Isolation: Biophysical Characterization. JACC Clin Electrophysiol. 2018 Apr;4(4):467-479. doi: 10.1016/j.jacep.2017.11.018. Epub 2018 Feb 2.

  PMID: 30067486 BACKGROUND

• Barkagan M, Contreras-Valdes FM, Leshem E, Buxton AE, Nakagawa H, Anter E. High-power and short-duration ablation for pulmonary vein isolation: Safety, efficacy, and long-term durability. J Cardiovasc Electrophysiol. 2018 Sep;29(9):1287-1296. doi: 10.1111/jce.13651. Epub 2018 Jun 20.

  PMID: 29846987 BACKGROUND

• Reddy VY, Grimaldi M, De Potter T, Vijgen JM, Bulava A, Duytschaever MF, Martinek M, Natale A, Knecht S, Neuzil P, Purerfellner H. Pulmonary Vein Isolation With Very High Power, Short Duration, Temperature-Controlled Lesions: The QDOT-FAST Trial. JACC Clin Electrophysiol. 2019 Jul;5(7):778-786. doi: 10.1016/j.jacep.2019.04.009. Epub 2019 May 8.

  PMID: 31320006 BACKGROUND

• Falasconi G, Penela D, Soto-Iglesias D, Francia P, Saglietto A, Turturiello D, Viveros D, Bellido A, Alderete J, Zaraket F, Franco-Ocana P, Huguet M, Camara O, Vatasescu R, Ortiz-Perez JT, Marti-Almor J, Berruezo A. Personalized pulmonary vein isolation with very high-power short-duration lesions guided by left atrial wall thickness: the QDOT-by-LAWT randomized trial. Europace. 2024 Mar 30;26(4):euae087. doi: 10.1093/europace/euae087.

  PMID: 38652090 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Antonio Berruezo, MD, PhD

  Centro Medico Teknon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Berruezo, MD, PhD

CONTACT

(+34) 93 290 62 51; antonio.berruezo@quironsalud.es

Beatriz Jáuregui, MD

CONTACT

(+34) 93 290 62 51; beatriz.jauregui@quironsalud.es

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Coordinator of the Heart Institute

Model Details: This is a two-arm, single-blind, single-center, randomized controlled trial.

Study Record Dates

• First Submitted: February 29, 2020
• First Posted: March 6, 2020
• Study Start: March 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 30, 2023
• Last Updated: August 30, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)