Pressure Wave Guided Atrial Fibrillation Cryoablation (POLAR-WAVE)

Pressure Wave Guided Atrial Fibrillation Cryoablation: POLAR-WAVE Registry

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

Study Overview

• Status: Recruiting
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Procedure: cryoablation of pulmonary veins

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Adolfo Fontenla, MD, PhD; Phone Number: 917792456; Email: adolforamon.fontela@salud.madrid.org

Study Locations

• Spain
  • Madrid, Spain, 28015
    • Recruiting
    • Hospital Universitario 12 de octubre
    • Contact: Adolfo Fontenla, MD, PhD; Phone Number: 917792456; Email: adolforamon.fontela@saludmadrid.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successfully completed ablation procedures	Proportion of pulmonary vein isolation (PVI) procedures exclusively guided by pressure	12 months
Symptoms associated with atrial fibrillation	European Heart Rhythm Association Symptom Scale (I-IV). Higher scores mean a worse outcome.	12 months
Safety events	Proportion of serious and non-serious procedure related events	30 days
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
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
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
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
Radiation dose	Mean radiation required for pulmonary vein isolation (Gycm2)	1 day

Collaborators and Investigators

• Sponsor: Hospital Universitario 12 de Octubre
• Collaborators: Boston Scientific Corporation
• Investigators: Study Chair: Adolfo Fontenla, MD, PhD, Hospital Universitario 12 de Octubre, Madrid. Spain

Publications and helpful links

General Publications

• 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.
• 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.
• Siklódy CH, Minners J, Allgeier M, Allgeier HJ, Jander N, Keyl C, Weber R, Schiebeling-Römer 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.
• 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.
• 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.
• 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 Aug 26. pii: euac148. doi: 10.1093/europace/euac148. [Epub ahead of print]
• 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 Apr 12. doi: 10.1007/s10840-022-01200-5. [Epub ahead of print]
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2022
• Primary Completion (Anticipated): March 31, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): November 2, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 26, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Cryoablation; Pressure waveforms
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: POLAR-WAVE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes