Pressure Wave Guided Atrial Fibrillation Cryoablation

NCT05603091 | Unknown

• 1 other identifier: POLAR-WAVE
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective multicenter observational study evaluating the performance of pressure wave-guided atrial fibrillation cryoablation used in accordance with clinical practice guidelines.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Cryoablation; Pressure waveforms

Outcome Measures

Primary Outcomes (1)

• Atrial tachycardia and/or atrial fibrillation (AT/AF) free survival

  Proportion of patients without AT/AF episodes (excluding a window period of 3 months from ablation)

  12 months

Secondary Outcomes (8)

• Successfully completed ablation procedures

  12 months

• Symptoms associated with atrial fibrillation

  12 months

• Safety events

  30 days

• Acute results of pressure guided cryoablation procedures (global and for each vein)

  1 day

• Performance of pressure guided cryoablation procedures

  1 day

Study Arms (1)

Pressure guided cryoablation

Patients undergoing cryoablation of atrial fibrillation with catheter-balloon, where the evaluation of the pulmonary veins occlusion will be assessed by the analysis of the pressure waveforms obtained from the tip of the catheter (without injecting contrast).

Procedure: cryoablation of pulmonary veins

Interventions

cryoablation of pulmonary veins PROCEDURE

Procedures are guided by pressure waveforms analysis, which are obtained by connecting the internal lumen of the catheter through the lateral port of the hemostatic valve attached to the catheter, to a pressure transducer connected in turn to a heparinized saline serum bag and to the cryoablation console.

Pressure guided cryoablation

Eligibility Criteria

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

Study Population

The study population is composed of patients who are candidates for paroxysmal or persistent AF ablation, in accordance with the conventional indications of the technique according to current European clinical practice guidelines

You may qualify if:

• Age over 18 years.
• Paroxysmal, persistent, or long-lasting persistent atrial fibrillation.
• Indication of pulmonary vein ablation according to clinical practice guidelines.

You may not qualify if:

• Previous ablation of atrial fibrillation.
• Thrombus in the left atrium.
• Rheumatic heart disease.
• Hypertrophic cardiomyopathy.
• Absolute contraindication to anticoagulation.
• Women in a state of pregnancy, lactation or childbearing age without contraception.
• Life expectancy \< 1 year.

Sponsors & Collaborators

• Hospital Universitario 12 de Octubre: lead
• Boston Scientific Corporation: collaborator

Study Sites (1)

Hospital Universitario 12 de Octubre

Madrid, 28015, Spain

RECRUITING

Related Publications (8)

• 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

• Kuck KH, Brugada J, Furnkranz A, Metzner A, Ouyang F, Chun KR, Elvan A, Arentz T, Bestehorn K, Pocock SJ, Albenque JP, Tondo C; FIRE AND ICE Investigators. Cryoballoon or Radiofrequency Ablation for Paroxysmal Atrial Fibrillation. N Engl J Med. 2016 Jun 9;374(23):2235-45. doi: 10.1056/NEJMoa1602014. Epub 2016 Apr 4.

  PMID: 27042964 BACKGROUND

• Siklody CH, Minners J, Allgeier M, Allgeier HJ, Jander N, Keyl C, Weber R, Schiebeling-Romer J, Kalusche D, Arentz T. Pressure-guided cryoballoon isolation of the pulmonary veins for the treatment of paroxysmal atrial fibrillation. J Cardiovasc Electrophysiol. 2010 Feb;21(2):120-5. doi: 10.1111/j.1540-8167.2009.01600.x. Epub 2009 Sep 28.

  PMID: 19793145 BACKGROUND

• Raizada A, Gedela M, Shaikh KA, Apte N, DeHaan M, Stanton C. Pressure-Guided cryoablation of pulmonary veins in atrial fibrillation: A fast and effective strategy. Indian Heart J. 2017 Mar-Apr;69(2):223-225. doi: 10.1016/j.ihj.2016.11.330. Epub 2016 Dec 5.

  PMID: 28460771 BACKGROUND

• Hasegawa K, Miyazaki S, Kaseno K, Hisazaki K, Amaya N, Miyahara K, Aiki T, Ishikawa E, Mukai M, Matsui A, Aoyama D, Shiomi Y, Tama N, Ikeda H, Fukuoka Y, Morishita T, Ishida K, Uzui H, Tada H. Pressure-guided second-generation cryoballoon pulmonary vein isolation: Prospective comparison of the procedural and clinical outcomes with the conventional strategy. J Cardiovasc Electrophysiol. 2019 Oct;30(10):1841-1847. doi: 10.1111/jce.14080. Epub 2019 Aug 4.

  PMID: 31328311 BACKGROUND

• Heeger CH, Pott A, Sohns C, Riesinger L, Sommer P, Gasperetti A, Tondo C, Fassini G, Moser F, Lucas P, Weinmann K, Bohnen JE, Dahme T, Rillig A, Kuck KH, Wakili R, Metzner A, Tilz RR. Novel cryoballoon ablation system for pulmonary vein isolation: multicenter assessment of efficacy and safety-ANTARCTICA study. Europace. 2022 Dec 9;24(12):1917-1925. doi: 10.1093/europace/euac148.

  PMID: 36026521 BACKGROUND

• Martin A, Fowler M, Breskovic T, Ouss A, Dekker L, Yap SC, Bhagwandien R, Albrecht EM, Cielen N, Richards E, Tran BC, Lever N, Anic A. Novel cryoballoon to isolate pulmonary veins in patients with paroxysmal atrial fibrillation: long-term outcomes in a multicentre clinical study. J Interv Card Electrophysiol. 2022 Dec;65(3):609-616. doi: 10.1007/s10840-022-01200-5. Epub 2022 Apr 12.

  PMID: 35412168 BACKGROUND

• 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. Heart Rhythm. 2017 Oct;14(10):e275-e444. doi: 10.1016/j.hrthm.2017.05.012. Epub 2017 May 12. No abstract available.

  PMID: 28506916 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Adolfo Fontenla, MD, PhD

  Hospital Universitario 12 de Octubre, Madrid. Spain

  STUDY CHAIR

Central Study Contacts

Adolfo Fontenla, MD, PhD

CONTACT

917792456; adolforamon.fontela@salud.madrid.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: November 2, 2022
• Study Start: October 19, 2022
• Primary Completion: March 31, 2024
• Study Completion: June 30, 2024
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

ES (1)