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Cryoballoon PVI With PWI Versus PVI Alone In Patients With PAF

NCT05296824 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 320

Last updated 2025-11-05

Study results available
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Summary

Cryoballoon ablation has emerged as a safe and effective strategy for treatment of atrial fibrillation (AF) for which it has recently received a 'first-line' therapy indication by the FDA. Pulmonary vein (PV) isolation (PVI) has been the cornerstone of this procedure achieving freedom from recurrent AF in up to \~80% of patients at 12 months of follow-up. However, the success has been shown to be significantly lower, in the range of 50-60% at 3-5 years of follow-up. Other more recent cryoballoon ablation studies have demonstrated marked improvements in clinical outcomes associated with concomitant PVI and cryoballoon ablation/isolation of the 'PV component' (a region of the left atrial posterior \[back\] wall lying between the PVs that is anatomically and embryologically related to the PVs), versus PVI alone in patients with persistent AF.

PVI+PWI using cryoballoon ablation has been widely-practiced in patients with paroxysmal AF. However, the acute/long-term safety and efficacy of this approach has not been formally investigated in paroxysmal AF. Given the mechanistic similarities between persistent and paroxysmal AF, the investigators hypothesize that similar benefits associated with PVI+PWI may also be observed in those with paroxysmal AF. Yet, due to the relative infrequency of breakthrough/recurrent arrhythmias in patients with PAF, to detect a significant difference, large sample sizes and extended follow-up (\>24 months) are likely needed. Hence, the aim of this retrospective, observational study is to examine the acute and long-term efficacy and safety beyond 36 months of follow-up associated with PVI alone versus PVI+PWI using cryoballoon ablation in a large cohort of patients with PAF, performed by a single operator between 1/1/2014 and 8/31/2018 at Mercy General Hospital.

Conditions

  • Paroxysmal Atrial Fibrillation

Interventions

PROCEDURE

Cryoballoon ablation for the treatment of atrial fibrillation

Cryoballoon ablation for the treatment of atrial fibrillation

Sponsors & Collaborators

  • Mercy General Hospital and Dignity Health Heart and Vascular Institute

    collaborator UNKNOWN

  • UC Health Medical Center

    collaborator UNKNOWN

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • Beth Israel Deaconess Medical Center

    collaborator OTHER

  • Sacramento EP Research

    lead OTHER

Principal Investigators

  • Arash Aryana, MD, PhD · Mercy General Hospital and Dignity Health Heart and Vascular Institute

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-01
Primary Completion
2018-08-31
Completion
2021-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05296824 on ClinicalTrials.gov