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

NCT ID: NCT04408716

Last Updated: 2023-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-17

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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Radiofrequency catheter ablation is increasingly performed in patients with paroxysmal and persistent atrial fibrillation (AF) in recent decade. However, catheter ablation of AF is associated with the occurrence of procedure-related thromboembolic events, especially the risk of asymptomatic cerebral embolism detected by brain high-resolution diffusion-weighted magnetic resonance imaging (hDWI). Meanwhile, ablation index guided high-power short-duration (AI-HPSD) strategy with the advanced SmartTouch SurroundFlow (STSF) catheter is an increasingly used technique for catheter ablation of AF, which is proposed to be associated with relatively wider and superficial lesions, less risk of esophageal injury, and shorter procedure time plus higher rate of first-pass pulmonary vein isolation. Moreover, the advanced STSF catheter in AI-HPSD strategy features with the Surround Flow entire tip irrigation system, which is a wide-spread distribution of the irrigating solution (56 irrigation holes), resulting in homogenous cooling and protection from thrombus formation and reduced incidence of steam pops. Thus, comparing with the standard radiofrequency ablation technique using the SmartTouch (ST) catheter, the AI-HPSD strategy may associate with much lower risk of periprocedural asymptomatic cerebral embolism, with the application of advanced STSF catheter and shorter procedure time. Therefore, this study is designed as a prospective randomized controlled study to evaluate the risk of asymptomatic cerebral embolism during catheter ablation of AF with AI-HPSD strategy versus standard radiofrequency ablation settings, with the diagnosis of asymptomatic cerebral embolism is determined by brain hDWI.

Conditions

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Atrial Fibrillation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Ablation Index Guided High-Power Short-Duration Group

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).

Group Type EXPERIMENTAL

Ablation Index Guided High-Power Short-Duration Strategy

Intervention Type 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).

Standard Radiofrequency Ablation Group

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).

Group Type ACTIVE_COMPARATOR

Standard Radiofrequency Ablation Technique

Intervention Type 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).

Interventions

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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).

Intervention Type PROCEDURE

Standard Radiofrequency Ablation Technique

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).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yuehui Yin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Second Affilliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 30848001 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31937118 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28340141 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26948985 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32147899 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31713704 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31600006 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31588620 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37996906 (View on PubMed)

Related Links

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https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-023-03180-3

Publications regarding the results of this Reduce-It Study.

Other Identifiers

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REDUCE-IT Study

Identifier Type: -

Identifier Source: org_study_id