Risk of Asymptomatic Cerebral Embolism During AF Ablation With AI-HPSD Strategy Versus Standard Settings

NCT04408716 | Completed DMC

• 1 other identifier: REDUCE-IT Study
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this prospective randomized controlled study is to evaluate the risk of asymptomatic cerebral embolism during catheter ablation of atrial fibrillation (AF) with AI-HPSD strategy versus standard radiofrequency ablation settings, with the diagnosis of asymptomatic cerebral embolism is determined by brain high-resolution diffusion-weighted magnetic resonance imaging technique.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Asymptomatic Cerebral Embolism; radiofrequency ablation

Outcome Measures

Primary Outcomes (1)

• The incidence of new asymptomatic cerebral embolic lesions determined by hDWI.

  The brain hDWI should be performed within 3 days prior to the ablation procedure to investigate previous cerebral lesions and reevaluated within 24-72 hours post ablation to determine the occurrence of new asymptomatic cerebral embolic lesions. The acute cerebral embolic lesion is typically defined as a new focal hyper-intense area detected on the diffusion-weighted sequence, and a hyper-intense signal intensity in the fluid-attenuated inversion recovery sequence, and meantime confirmed by apparent diffusion coefficient mapping as corresponding area of restricted diffusion to rule out a shine-through artifact.

  Within 3 days prior to the ablation；24-72 hours after AF catheter ablation procedure.

Secondary Outcomes (2)

• Cognitive functional status evaluated using the Montreal Cognitive Assessment (MoCA) test.

  On the 1 day before and 24-72 hours and 3 months after the catheter ablation procedure.

• Overall complication rate during catheter ablation and up to 3 months follow up.

  3 months after the catheter ablation procedure.

Study Arms (2)

Ablation Index Guided High-Power Short-Duration Group

EXPERIMENTAL

For patients assigned to undergo AF ablation with ablation index guided high-power short-duration strategy, point-by-point circumferential pulmonary vein ablation will be performed using the advanced STSF catheter under ablation index guided high power short duration strategy (Radiofrequency energy is set up at a power of 50 W, temperature of 43 °C, contact force of 5-20 gram, and flow rate of 20 mL/min; Target ablation index is set to 500 at the anterior wall and 350 at the posterior wall of left atrium).

Procedure: Ablation Index Guided High-Power Short-Duration Strategy

Standard Radiofrequency Ablation Group

ACTIVE COMPARATOR

For patients assigned to undergo AF ablation with standard radiofrequency ablation group, point-by-point circumferential pulmonary vein ablation will be performed using the ST catheter under standard radiofrequency ablation settings (Radiofrequency energy is set up at a power of 30 to 35 W, temperature of 43 °C, contact force of 5-20 gram, and flow rate of 17 to 30 mL/min. Target ablation index is set to 500 at the anterior wall and 350 at the posterior wall of left atrium).

Procedure: Standard Radiofrequency Ablation Technique

Interventions

Ablation Index Guided High-Power Short-Duration Strategy PROCEDURE

Point-by-point circumferential pulmonary vein ablation will be performed using the advanced STSF catheter under ablation index guided high power short duration strategy (Radiofrequency energy is set up at a power of 50 W, temperature of 43 °C, contact force of 5-20 gram, and flow rate of 20 mL/min; Target ablation index is set to 500 at the anterior wall and 350 at the posterior wall of left atrium).

Ablation Index Guided High-Power Short-Duration Group

Standard Radiofrequency Ablation Technique PROCEDURE

Point-by-point circumferential pulmonary vein ablation will be performed using the ST catheter under standard radiofrequency ablation settings (Radiofrequency energy is set up at a power of 30 to 35 W, temperature of 43 °C, contact force of 5-20 gram, and flow rate of 17 to 30 mL/min. Target ablation index is set to 500 at the anterior wall and 350 at the posterior wall of left atrium).

Standard Radiofrequency Ablation Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients≥18 years of age prior to obtaining the written informed consent.
• Patients with electrocardiographically documented, symptomatic atrial fibrillation.
• Patients is scheduled to undergo circumferential pulmonary vein antrum radiofrequency ablation.
• Patient or patient's legal representative is able and willing to give informed consent.

You may not qualify if:

• Moderate to severe valvular heart disease.
• Contraindication for anticoagulation therapy.
• Contraindication for Diffusion-Weighted MRI.
• Ischemic stroke or transient ischemic attack within 6 months prior to the consent date.
• Acute coronary syndrome within 3 months prior to the consent date.
• Prior left atrial appendage occlusion device.
• Prior septal occlusion device.
• Left atrial size greater than 55 mm.
• Conditions that prevent patient's participation in neurocognitive assessment (at physician's discretion).
• Female patients who are pregnant or breast feeding or plan a pregnancy during the course of the study.
• Simultaneous participation in another study.
• Unwilling or unable to comply fully with the study procedures and follow-up requirements.

Sponsors & Collaborators

• The Second Affiliated Hospital of Chongqing Medical University: lead

Study Sites (1)

The Second Affilliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400010, China

Location

Related Publications (9)

• Schmidt B, Szeplaki G, Merkely B, Kautzner J, van Driel V, Bourier F, Kuniss M, Bulava A, Nolker G, Khan M, Lewalter T, Klein N, Wenzel B, Chun JK, Shah D. Silent cerebral lesions and cognitive function after pulmonary vein isolation with an irrigated gold-tip catheter: REDUCE-TE Pilot study. J Cardiovasc Electrophysiol. 2019 Jun;30(6):877-885. doi: 10.1111/jce.13902. Epub 2019 Mar 25.

  PMID: 30848001 BACKGROUND

• Yu Y, Wang X, Li X, Zhou X, Liao S, Yang W, Yu J, Zhang F, Ju W, Chen H, Yang G, Li M, Gu K, Tang L, Xu Y, Chan JY, Kojodjojo P, Cao K, Fan J, Yang B, Chen M. Higher Incidence of Asymptomatic Cerebral Emboli After Atrial Fibrillation Ablation Found With High-Resolution Diffusion-Weighted Magnetic Resonance Imaging. Circ Arrhythm Electrophysiol. 2020 Jan;13(1):e007548. doi: 10.1161/CIRCEP.119.007548. Epub 2020 Jan 14.

  PMID: 31937118 BACKGROUND

• Providencia R, Albenque JP, Boveda S. The unfinished issue of ischaemic stroke and embolic events during catheter ablation of atrial fibrillation. Europace. 2017 May 1;19(5):881. doi: 10.1093/europace/euw027. No abstract available.

  PMID: 28340141 BACKGROUND

• Yamane T. Silent Cerebral Embolism After Catheter Ablation for Atrial Fibrillation - Unresolved Issue or Too Much Concern? Circ J. 2016;80(4):814-5. doi: 10.1253/circj.CJ-16-0186. Epub 2016 Mar 7. No abstract available.

  PMID: 26948985 BACKGROUND

• Kyriakopoulou M, Wielandts JY, Strisciuglio T, El Haddad M, Pooter J, Almorad A, Hilfiker G, Phlips T, Unger P, Lycke M, Vandekerckhove Y, Tavernier R, Duytschaever M, Knecht S. Evaluation of higher power delivery during RF pulmonary vein isolation using optimized and contiguous lesions. J Cardiovasc Electrophysiol. 2020 May;31(5):1091-1098. doi: 10.1111/jce.14438. Epub 2020 Mar 18.

  PMID: 32147899 BACKGROUND

• Castrejon-Castrejon S, Martinez Cossiani M, Ortega Molina M, Escobar C, Froilan Torres C, Gonzalo Bada N, Diaz de la Torre M, Suarez Parga JM, Lopez Sendon JL, Merino JL. Feasibility and safety of pulmonary vein isolation by high-power short-duration radiofrequency application: short-term results of the POWER-FAST PILOT study. J Interv Card Electrophysiol. 2020 Jan;57(1):57-65. doi: 10.1007/s10840-019-00645-5. Epub 2019 Nov 12.

  PMID: 31713704 BACKGROUND

• Okamatsu H, Koyama J, Sakai Y, Negishi K, Hayashi K, Tsurugi T, Tanaka Y, Nakao K, Sakamoto T, Okumura K. High-power application is associated with shorter procedure time and higher rate of first-pass pulmonary vein isolation in ablation index-guided atrial fibrillation ablation. J Cardiovasc Electrophysiol. 2019 Dec;30(12):2751-2758. doi: 10.1111/jce.14223. Epub 2019 Oct 21.

  PMID: 31600006 BACKGROUND

• Chen S, Schmidt B, Bordignon S, Urbanek L, Tohoku S, Bologna F, Angelkov L, Garvanski I, Tsianakas N, Konstantinou A, Trolese L, Weise F, Perrotta L, Chun KRJ. Ablation index-guided 50 W ablation for pulmonary vein isolation in patients with atrial fibrillation: Procedural data, lesion analysis, and initial results from the FAFA AI High Power Study. J Cardiovasc Electrophysiol. 2019 Dec;30(12):2724-2731. doi: 10.1111/jce.14219. Epub 2019 Oct 13.

  PMID: 31588620 BACKGROUND

• Chen WJ, Gan CX, Cai YW, Liu YY, Xiao PL, Zou LL, Xiong QS, Qin F, Tao XX, Li R, Du HA, Liu ZZ, Yin YH, Ling ZY. Impact of high-power short-duration atrial fibrillation ablation technique on the incidence of silent cerebral embolism: a prospective randomized controlled study. BMC Med. 2023 Nov 23;21(1):461. doi: 10.1186/s12916-023-03180-3.

  PMID: 37996906 DERIVED

Related Links

• Publications regarding the results of this Reduce-It Study.

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study is a single center prospective single-blinded randomized controlled trial. Enrolled AF patients planning clinically-indicated catheter ablation is randomly assigned with 1:1 ratio to undergo catheter ablation with ablation index guided high-power short-duration strategy or the standard radiofrequency ablation technique. Besides the evaluation at baseline, all the participants will be followed up at 24-72 hours, 1 month and 3 months post ablation.

Study Record Dates

• First Submitted: May 26, 2020
• First Posted: May 29, 2020
• Study Start: June 17, 2020
• Primary Completion: September 13, 2021
• Study Completion: December 31, 2021
• Last Updated: November 28, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)