MedDataX Logo

Cryoballoon Isolation of Superior Vena Cava in Paroxysmal Atrial Fibrillation

NCT ID: NCT05081310

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Paroxysmal atrial fibrillation can be triggered by non-pulmonary vein foci, like the superior vena cava. There are some older publications showing improved result in terms of freedom from atrial tachycardias when electrical isolation of this vessel utilizing radiofrequency energy is achieved. Recent retrospective studies showed that isolation of superior vena cava by the means of cryoballoon technology is safe and feasible procedure. Furthermore, one retrospective cohort study showed improved outcomes of SVC insolation + PVI versus PVI only strategy. To our knowledge there is still no randomized data that compared SVC isolation + PVI vs PVI only strategy when using cryoballoon technology.

The investigators want to determine if SVC isolation by the means of cryoballoon technology in conjunction with PVI can improve the patients outcomes. Also, there will be focus on the safety of the procedure, especially regarding the right sided phrenic nerve palsy. The primary objective of the study is freedom from atrial arrhythmias defined by standard postprocedural monitoring by ECG and Holter monitors. The investigators are conducting a randomized study with 1:1 randomization and planning to enroll around 100 participants with 1 year follow up. One group will receive conventional cryoballoon pulmonary vein isolation, and other group will receive SVC isolation after the PVI procedure.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Atrial Fibrillation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SVC arm

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

Group Type EXPERIMENTAL

superior vena cava isolation

Intervention Type DEVICE

SVC isolation by the means of cryoballoon

PVI arm

Patients who will receive convectional cryoballoon PVI procedure

Group Type ACTIVE_COMPARATOR

pulmonary vein isolation

Intervention Type DEVICE

conventional pulmonary vein isolation by the means of cryoballoon

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

superior vena cava isolation

SVC isolation by the means of cryoballoon

Intervention Type DEVICE

pulmonary vein isolation

conventional pulmonary vein isolation by the means of cryoballoon

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

persistent atrial fibrillation

* renal failure
* contrast allergy
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Zagreb

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Vedran Velagic

MD, PhD, Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Vedran Velagic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinical Hospital Centre Zagreb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

KBC Zagreb

Zagreb, , Croatia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Croatia

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 33447964 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32250512 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32253600 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SVC001

Identifier Type: -

Identifier Source: org_study_id