Pressure Wave Guided Atrial Fibrillation Cryoablation

Atrial Fibrillation Clinical Trial

— POLAR-WAVE  

Official title:

Pressure Wave Guided Atrial Fibrillation Cryoablation: POLAR-WAVE Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05603091
• Other study ID #: POLAR-WAVE
• Status: Recruiting
• Start date: October 19, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2023
• Source: Hospital Universitario 12 de Octubre
• Contact: Adolfo Fontenla, MD, PhD
• Phone: 917792456
• Email: adolforamon.fontela[@]salud.madrid.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

The POLAR-WAVE registry is a prospective, multi-center, single-arm study evaluating the efficacy and safety of pressure-guided atrial fibrillation cryoablation, where the occlusion of pulmonary veins will be assessed by pressure waveforms (instead of contrast), over a follow-up period of 12 months.

This is a non-commercial, investigator-driven clinical study, coordinated by the main investigator from University Hospital "12th of October", Madrid, Spain. Several responsibilities are delegated to the Clinical Research Unit (University Hospital "12th of October", Madrid, Spain).

The study was planned according to the Good Clinical Practices. POLAR-WAVE Study has been approved by the Ethics Committee and Spanish Health Authorities. All participating patients must give written informed consent.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age over 18 years.

• Paroxysmal, persistent, or long-lasting persistent atrial fibrillation.

• Indication of pulmonary vein ablation according to clinical practice guidelines.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• cryoablation of pulmonary veins
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.

Locations

Country	Name	City	State
Spain	Hospital Universitario 12 de Octubre	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario 12 de Octubre	Boston Scientific Corporation

Country where clinical trial is conducted

Spain, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Eur Heart J. 2021 Feb 1;42(5):507. Eur Heart J. 2021 Feb 1;42(5):546-547. Eur Heart J. 2021 Oct 21;42(40):4194. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Successfully completed ablation procedures	Proportion of pulmonary vein isolation (PVI) procedures exclusively guided by pressure	12 months
Secondary	Symptoms associated with atrial fibrillation	European Heart Rhythm Association Symptom Scale (I-IV). Higher scores mean a worse outcome.	12 months
Secondary	Safety events	Proportion of serious and non-serious procedure related events	30 days
Secondary	Acute results of pressure guided cryoablation procedures (global and for each vein)	proportion of isolated veins, proportion of isolated veins with single application.	1 day
Secondary	Performance of pressure guided cryoablation procedures	Total procedure time (min), dwell time in the left atrium (min), cryotherapy time (min), fluoroscopy time (min)	1 day
Secondary	Temperature parameters obtained during pressure guided cryoablation procedures (global and for each vein)	Minimum temperature (degrees Celsius); Temperature at 30 seconds (degrees Celsius); Temperature at 60 seconds (degrees Celsius)	1 day
Secondary	Time parameters obtained during pressure guided cryoablation	Time up to -40 degrees Celsius (sec); Time up to -50 degrees Celsius (sec); Defrosting time up to 0 degrees Celsius (sec); Defrosting time up to +15 degrees Celsius (sec)	1 day
Secondary	Radiation dose	Mean radiation required for pulmonary vein isolation (Gycm2)	1 day