Balloon Cryoablation Without Contrast

NCT04344743 | Unknown FDA Device

• 1 other identifier: 1_2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

Pulmonary vein isolation using cryoballoon ablation is well established method for the treatment of atrial fibrillation. As a rule, cryoenergy delivery is preceded by documenting the full vein occlusion. It is assessed by venography, performed by injecting contrast through the inner lumen of the balloon catheter after the vein is blocked with a balloon. Achieving full vein occlusion in certain situations can be challenging and may require multiple attempts, which may expose the patient to increased doses of contrast and radiation.. At the same time, the purpose of ablation is an electrical isolation of pulmonary veins. Experts postulate ablation in the antrum and the so-called "proximal-seal technique", which in some cases may require to start cryoapplication before the vein is fully sealed. This approach minimizes the risk of the pulmonary vein stenosis, damage to structures immediately adjacent to the atrium and phrenic nerve palsy. In addition, in many cases the displacement of the balloon after several dozen seconds of cryoapplication, usually by pulling it, causes full sealing of the vein, contributes to further lowering the temperature and leads to full electrical isolation of the vein, which is the aims of ablation. All the above-mentioned facts indicate that demonstrating full vein occlusion using angiography before the initiation of cryoenergy application is of limited value. Moreover, there are a number of parameters related to cryoballoon ablation that indicate acute and long term vein isolation. Taking into account the arguments presented above, it seems that it is possible to perform an effective and safe isolation of the pulmonary veins using the cryoballoon ablation technique without confirmation by venography that PV is occluded. Along with dissemination of the method, such attempts are and will be made by some operators. Therefore, a systematic approach to this issue is important. It should define the conditions that should be met in order for the procedure in the proposed modification to be implemented effectively and safely. In addition, a protocol of ablation for this modification is required.

Conditions

Paroxysmal Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Isolation of a pulmonary vein without the use of contrast and within the scheduled timeframe

  Acute result will be assessed. Vein isolation assessment will be done using a diagnostic circular catheter (Achieve, Medtronic), by demonstrating entrance and exit block

  Through study completion, an average of 2 years

Secondary Outcomes (7)

• Percentage of patients in whom isolation of all pulmonary veins will be achieved without the use of contrast

  Through study completion, an average of 2 years

• Percentage of patients with stable sinus rhythm, without atrial fibrillation episodes during follow-up

  During one year follow-up

• The amount of contrast dye used

  Through study completion, an average of 2 years

• X-ray time exposure

  Through study completion, an average of 2 years

• Radiation dose

  Through study completion, an average of 2 years

Study Arms (1)

Cryoballoon ablation without contrast

EXPERIMENTAL

Cryoballoon ablation without contrast

Device: Cryoballoon ablation without contrast

Interventions

Cryoballoon ablation without contrast DEVICE

Cryoballoon ablation without contrast

Cryoballoon ablation without contrast

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with paroxysmal AF - episodes lasting up to 7 days or cardioverted before this time
• At least 4 AF attacks in the last 12 months
• Informed consent for participation in the study
• Age \> 18 and \< 70 years
• Left atrium diameter (PLAX) \< 4,5 cm and left atrial area \< = 30 cm2
• Left ventricle ejection fraction \> 45%
• Four separate veins visualised in computed tomography prior to the ablation

You may not qualify if:

• Withdrawal of consent for the procedure
• Documented typical atrial flutter prior to the ablation
• Thrombus in left atrium
• GFR \< 60 ml/min
• Pregnancy
• Common trunk of left or right pulmonary veins documented on computed tomography (preferred) or by means of other imaging methods
• Other conditions that preclude AF ablation including: infection, uncontrolled hyperthyroidism, significant anaemia and thrombocytopenia, acute cardiac / internist / surgical conditions

Sponsors & Collaborators

• Medicover Hospital: lead
• National Institute of Cardiology, Warsaw, Poland: collaborator

Study Sites (2)

Medicover Hospital

Warsaw, Poland

RECRUITING

National Institute of Cardiology

Warsaw, Poland

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Pawel Derejko, MD, PhD

  Medicover Hospital, Warsaw, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pawel Derejko, MD, PhD

CONTACT

+48603338871; pawel.derejko@medicover.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Cardiology Department

Study Record Dates

• First Submitted: April 5, 2020
• First Posted: April 14, 2020
• Study Start: August 13, 2020
• Primary Completion: August 1, 2021
• Study Completion: June 1, 2022
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 5 years following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose. For individual participant data meta-analysis

Locations

PL (2)