Cryoballoon Isolation of Superior Vena Cava in Paroxysmal Atrial Fibrillation

NCT05081310 | Unknown

• 1 other identifier: SVC001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

There is still unresolved question whether isolation of superior vena cava (SVC) in conjunction to conventional pulmonary vein isolation (PVI) improves outcomes in the treatment of paroxysmal atrial fibrillation. The investigators are conducting a randomized study to determine if SVC isolation (in addition to pulmonary vein isolation) with the cryoballoon technology can improve freedom from atrial arrhythmias in one year follow up after the ablation.

Conditions

Atrial Fibrillation

Keywords

pulmonary vein isolation; superior vena cava isolation; cryoballoon ablation

Outcome Measures

Primary Outcomes (1)

• efficacy

  number of patients free of any atrial arrhythmias during the one year of follow up (occurrence of any atrial arrhythmia longer than 30 seconds, detected by Holter EKG or 12 lead EKG will be considered as treatment failure)

  one year

Secondary Outcomes (2)

• feasibility

  during the procedure

• safety

  one year

Study Arms (2)

SVC arm

EXPERIMENTAL

Patients who will receive SVC isolation by the means of cryoballoon after the PVI procedure

Device: superior vena cava isolation

PVI arm

ACTIVE COMPARATOR

Patients who will receive convectional cryoballoon PVI procedure

Device: pulmonary vein isolation

Interventions

superior vena cava isolation DEVICE

SVC isolation by the means of cryoballoon

SVC arm

pulmonary vein isolation DEVICE

conventional pulmonary vein isolation by the means of cryoballoon

PVI arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• paroxysmal atrial fibrillation scheduled for cryoballoon the ablation of atrial fibrillation (indication not related to the study)

You may not qualify if:

• persistent atrial fibrillation
• renal failure
• contrast allergy

Sponsors & Collaborators

• University of Zagreb: lead

Study Sites (1)

KBC Zagreb

Zagreb, 10000, Croatia

Location

Related Publications (3)

• Overeinder I, Osorio TG, Calburean PA, Bisignani A, Bala G, Sieira J, Stroker E, Al Houssari M, Mojica J, Boveda S, Paparella G, Brugada P, de Asmundis C, Chierchia GB. Comparison between superior vena cava ablation in addition to pulmonary vein isolation and standard pulmonary vein isolation in patients with paroxysmal atrial fibrillation with the cryoballoon technique. J Interv Card Electrophysiol. 2021 Dec;62(3):579-586. doi: 10.1007/s10840-020-00932-6. Epub 2021 Jan 15.

  PMID: 33447964 BACKGROUND

• Wei HQ, Guo XG, Sun Q, Yang JD, Xie HY, Cao ZJ, Chen YQ, Zhang S, Wu S, Ma J. Electrical isolation of the superior vena cava using second-generation cryoballoon in patients with atrial fibrillation. J Cardiovasc Electrophysiol. 2020 Jun;31(6):1307-1314. doi: 10.1111/jce.14477. Epub 2020 Apr 11.

  PMID: 32250512 BACKGROUND

• Iacopino S, Osorio TG, Filannino P, Artale P, Sieira J, Stroker E, Bala G, Overeinder I, Hacioglu E, Calburean PA, Paparella G, Brugada P, de Asmundis C, Chierchia GB. Safety and feasibility of electrical isolation of the superior vena cava in addition to pulmonary vein ablation for paroxysmal atrial fibrillation using the cryoballoon: lessons from a prospective study. J Interv Card Electrophysiol. 2021 Mar;60(2):255-260. doi: 10.1007/s10840-020-00740-y. Epub 2020 Apr 6.

  PMID: 32253600 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Study Officials

• Vedran Velagic, MD, PhD

  Clinical Hospital Centre Zagreb

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Assistant professor

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: October 18, 2021
• Study Start: June 1, 2021
• Primary Completion: July 30, 2024
• Study Completion: July 30, 2024
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)