CISPAF: Cryoballoon Isolation of Superior Vena Cava in Paroxysmal Atrial Fibrillation

Sponsor
University of Zagreb (Other)
Overall Status
Recruiting
CT.gov ID
NCT05081310
Collaborator
(none)
100
1
2
25.9
3.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: superior vena cava isolation
  • Device: pulmonary vein isolation
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Cryoballoon Isolation of Superior Vena Cava in Paroxysmal Atrial Fibrillation - a Randomized Study
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jul 30, 2022
Anticipated Study Completion Date :
Jul 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: SVC arm

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

Device: superior vena cava isolation
SVC isolation by the means of cryoballoon

Active Comparator: PVI arm

Patients who will receive convectional cryoballoon PVI procedure

Device: pulmonary vein isolation
conventional pulmonary vein isolation by the means of cryoballoon

Outcome Measures

Primary Outcome Measures

  1. efficacy [one year]

    percentage 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)

Secondary Outcome Measures

  1. feasibility [during the procedure]

    the success rates of SVC isolation. percentage of patients in whom successful SVC isolation was performed. SVC isolation will be verified by the circular mapping catheter, after the application of cryoballoon lesion. The absence of electrical signals in SVC after the ablation is considered as a successful isolation.

  2. safety [one year]

    adverse events during the procedure (specials consideration on phrenic nerve palsy) and after the procedure (groin hematoma, pericardial effusion, etc)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 KBC Zagreb Zagreb Croatia 10000

Sponsors and Collaborators

  • University of Zagreb

Investigators

  • Principal Investigator: Vedran Velagic, MD, PhD, Clinical Hospital Centre Zagreb

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Vedran Velagic, MD, PhD, Assistant professor, University of Zagreb
ClinicalTrials.gov Identifier:
NCT05081310
Other Study ID Numbers:
  • SVC001
First Posted:
Oct 18, 2021
Last Update Posted:
Oct 18, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Vedran Velagic, MD, PhD, Assistant professor, University of Zagreb
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 18, 2021