Impact of Catheter Stability on the Outcomes With Very High Power Short Duration Ablation

NCT06721221 | Active Not Recruiting

• 2 other identifiers: BM/8942-1/2023BWI-IIS-688
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Atrial fibrillation (AF), the most common cardiac rhythm disorder can be treated with pulmonary vein isolation (PVI). One technique for PVI is point-by-point radiofrequency ablation. Very high power short duration ablation is one of the most advanced technologies for radiofrequency ablation. However, acute efficacy results with this technology vary in a wide range. Improvements in automated tagging modules, incorporating tracking of cardiac and respiratory motion and enhanced stability algorithms, may allow for a better assessment of lesion quality and location and may improve the so called first-pass isolation rate (an indicator for acute procedural efficacy). Objective: To assess the acute procedural outcomes of very high power short duration PVI with the new enhanced stability software. Methods: Investigator-initiated, prospective, single-arm study on one hundred symptomatic patients with paroxysmal AF will undergo PVI with the QDOT catheter using a power setting of 90W(QMODE+). The inter-tag distance will be 6 mm posteriorly and 4 mm anteriorly, and the enhanced stability algorithm will be used in all cases. After creating the isolation circle, the presence or absence of first-pass isolation will be assessed on each side by the presence of entrance block. Primary endpoint will be first-pass isolation rate. Secondary outcomes are as follows: procedure time, left atrial dwell time, RF time, number of RF tags, use of a steerable sheath, occurrence of serious adverse events. Hypothesis: Very high power short duration PVI using the new stability software results in a higher rate of first-pass isolation than previously published.

Conditions

Atrial Fibrillation (AF); Atrial Fibrillation Ablation; Pulmonary Vein Isolation

Keywords

pulmonary vein isolation; catheter stability; first-pass isolation

Outcome Measures

Primary Outcomes (1)

• First-pass isolation rate

  After creating the isolation circle, the presence or absence of first-pass isolation will be assessed on each side by the presence of entrance block. If PVI is complete, this is defined as first-pass isolation. If PVI is not complete at this point, touch-up lesions will be delivered to reach the isolation of all pulmonary veins.

  Endpoint is assessed intra-procedurally

Secondary Outcomes (3)

• Acute reconnection

  Assessed 20 minutes after PVI is reached during the procedure

• 12-months AF freedom

  12-month from procedure

• Complications or adverse events

  1 month

Study Arms (1)

SVtag arm. Point-by-point PVI with the Svtag software

EXPERIMENTAL

PVI will be performed with QDot Micro catheter in QMODE plus with the Svtag software.

Device: Point-by-point PVI with the QDot Micro catheter in QMODE+ setting with the Svtag software

Interventions

Point-by-point PVI with the QDot Micro catheter in QMODE+ setting with the Svtag software DEVICE

PVI will be performed via femoral access after transseptal puncture, guided by fluoroscopy pressure monitoring, intracardiac echocardiography (ICE) or transesophageal echocardiography (TEE). A fast anatomical left atrial map will be created; then, point-by-point PVI will be performed with QDot Micro catheter in QMODE plus with the Svtag software. Inter-tag distance should be ≤ 6 mm on the posterior wall and ≤ 4 mm on the anterior wall. All applications' duration should be 4 seconds. After creating the isolation circle, the presence or absence of first-pass isolation will be assessed on each side by the presence of entrance block. If PVI is complete, this is defined as first-pass isolation. If PVI is not complete at this point, touch-up lesions will be delivered to reach the isolation of all pulmonary veins. After that, acute PV reconnections will be evaluated during a 20 minutes waiting period.

SVtag arm. Point-by-point PVI with the Svtag software

Eligibility Criteria

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

You may qualify if:

• Symptomatic paroxysmal or persistent AF
• Age \>18 years
• Willingness to sign the informed consent form

You may not qualify if:

• Contraindication to ablation
• Contraindication of long-term anticoagulation
• Long-standing persistent AF
• History of PVI
• History of cardiac surgery
• Pregnancy
• Active malignancy
• Life expectancy \<1 year
• Valvular AF
• Reversible cause of AF (e.g. hyperthyroidism).

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Heart and Vascular Center, Semmelweis University

Budapest, 1122, Hungary

Location

Related Publications (9)

• 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

• Kewcharoen J, Techorueangwiwat C, Kanitsoraphan C, Leesutipornchai T, Akoum N, Bunch TJ, Navaravong L. High-power short duration and low-power long duration in atrial fibrillation ablation: A meta-analysis. J Cardiovasc Electrophysiol. 2021 Jan;32(1):71-82. doi: 10.1111/jce.14806. Epub 2020 Nov 18.

  PMID: 33155303 BACKGROUND

• Nakagawa H, Ikeda A, Sharma T, Govari A, Ashton J, Maffre J, Lifshitz A, Fuimaono K, Yokoyama K, Wittkampf FHM, Jackman WM. Comparison of In Vivo Tissue Temperature Profile and Lesion Geometry for Radiofrequency Ablation With High Power-Short Duration and Moderate Power-Moderate Duration: Effects of Thermal Latency and Contact Force on Lesion Formation. Circ Arrhythm Electrophysiol. 2021 Jul;14(7):e009899. doi: 10.1161/CIRCEP.121.009899. Epub 2021 Jun 17.

  PMID: 34138641 BACKGROUND

• Hussein A, Das M, Riva S, Morgan M, Ronayne C, Sahni A, Shaw M, Todd D, Hall M, Modi S, Natale A, Dello Russo A, Snowdon R, Gupta D. Use of Ablation Index-Guided Ablation Results in High Rates of Durable Pulmonary Vein Isolation and Freedom From Arrhythmia in Persistent Atrial Fibrillation Patients: The PRAISE Study Results. Circ Arrhythm Electrophysiol. 2018 Sep;11(9):e006576. doi: 10.1161/CIRCEP.118.006576.

  PMID: 30354288 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

• Solimene F, Schillaci V, Shopova G, Urraro F, Arestia A, Iuliano A, Maresca F, Agresta A, La Rocca V, De Simone A, Stabile G. Safety and efficacy of atrial fibrillation ablation guided by Ablation Index module. J Interv Card Electrophysiol. 2019 Jan;54(1):9-15. doi: 10.1007/s10840-018-0420-5. Epub 2018 Jul 30.

  PMID: 30058055 BACKGROUND

• Szegedi N, Sallo Z, Perge P, Piros K, Nagy VK, Osztheimer I, Merkely B, Geller L. The role of local impedance drop in the acute lesion efficacy during pulmonary vein isolation performed with a new contact force sensing catheter-A pilot study. PLoS One. 2021 Sep 16;16(9):e0257050. doi: 10.1371/journal.pone.0257050. eCollection 2021.

  PMID: 34529678 BACKGROUND

• Haissaguerre M, Jais P, Shah DC, Takahashi A, Hocini M, Quiniou G, Garrigue S, Le Mouroux A, Le Metayer P, Clementy J. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med. 1998 Sep 3;339(10):659-66. doi: 10.1056/NEJM199809033391003.

  PMID: 9725923 BACKGROUND

• Hindricks G, Potpara T, Dagres N, Arbelo E, Bax JJ, Blomstrom-Lundqvist C, Boriani G, Castella M, Dan GA, Dilaveris PE, Fauchier L, Filippatos G, Kalman JM, La Meir M, Lane DA, Lebeau JP, Lettino M, Lip GYH, Pinto FJ, Thomas GN, Valgimigli M, Van Gelder IC, Van Putte BP, Watkins CL; ESC Scientific Document Group. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association for Cardio-Thoracic Surgery (EACTS): The Task Force for the diagnosis and management of atrial fibrillation of the European Society of Cardiology (ESC) Developed with the special contribution of the European Heart Rhythm Association (EHRA) of the ESC. Eur Heart J. 2021 Feb 1;42(5):373-498. doi: 10.1093/eurheartj/ehaa612. No abstract available.

  PMID: 32860505 BACKGROUND

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)