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POLAR-WAVE: Pressure Wave Guided Atrial Fibrillation Cryoablation

Sponsor
Hospital Universitario 12 de Octubre (Other)
Overall Status
Recruiting
CT.gov ID
NCT05603091
Collaborator
Boston Scientific Corporation (Industry)
100
Enrollment
1
Location
20.4
Anticipated Duration (Months)
4.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Pressure Wave Guided Atrial Fibrillation Cryoablation: POLAR-WAVE Registry
Actual Study Start Date :
Oct 19, 2022
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. Atrial tachycardia and/or atrial fibrillation (AT/AF) free survival [12 months]

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

Secondary Outcome Measures

  1. Successfully completed ablation procedures [12 months]

    Proportion of pulmonary vein isolation (PVI) procedures exclusively guided by pressure

  2. Symptoms associated with atrial fibrillation [12 months]

    European Heart Rhythm Association Symptom Scale (I-IV). Higher scores mean a worse outcome.

  3. Safety events [30 days]

    Proportion of serious and non-serious procedure related events

  4. Acute results of pressure guided cryoablation procedures (global and for each vein) [1 day]

    proportion of isolated veins, proportion of isolated veins with single application.

  5. Performance of pressure guided cryoablation procedures [1 day]

    Total procedure time (min), dwell time in the left atrium (min), cryotherapy time (min), fluoroscopy time (min)

  6. Temperature parameters obtained during pressure guided cryoablation procedures (global and for each vein) [1 day]

    Minimum temperature (degrees Celsius) Temperature at 30 seconds (degrees Celsius) Temperature at 60 seconds (degrees Celsius)

  7. Time parameters obtained during pressure guided cryoablation [1 day]

    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)

  8. Radiation dose [1 day]

    Mean radiation required for pulmonary vein isolation (Gycm2)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Universitario 12 de Octubre Madrid Spain 28015

Sponsors and Collaborators

  • Hospital Universitario 12 de Octubre
  • Boston Scientific Corporation

Investigators

  • Study Chair: Adolfo Fontenla, MD, PhD, Hospital Universitario 12 de Octubre, Madrid. Spain

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Adolfo Fontenla, Principal Investigator, Quirón Madrid University Hospital
ClinicalTrials.gov Identifier:
NCT05603091
Other Study ID Numbers:
  • POLAR-WAVE
First Posted:
Nov 2, 2022
Last Update Posted:
Jan 31, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Keywords provided by Adolfo Fontenla, Principal Investigator, Quirón Madrid University Hospital
Atrial fibrillation
Cryoablation
Pressure waveforms
Additional relevant MeSH terms:
Atrial Fibrillation

Study Results

No Results Posted as of Jan 31, 2023