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Cryoballoon PVI With PWI Versus PVI Alone In Patients With PAF
NCT05296824 · View on ClinicalTrials.gov ↗
Study 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 Studied
Interventions
- PROCEDURE Cryoballoon ablation for the treatment of atrial fibrillation
Study Locations (4)
California
- Mercy General Hospital and Dignity Health Heart and Vascular Institute — Sacramento
Colorado
- UC Health Medical Center — Loveland
Massachusetts
- Beth Israel Deaconess Medical Center — Boston
Texas
- University of Texas Health Science Center at Houston — Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 320 participants |
| Start Date | 2014-01-01 |
| Est. Completion | 2021-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05296824
The ClinicalTrials.gov registry entry for NCT05296824 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sacramento EP Research, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Paroxysmal Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention — of which Cryoballoon ablation for the treatment of atrial fibrillation is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05296824 reports 4 study locations spanning 4 distinct geographic areas — top geographies include California, Colorado, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05296824 about?
NCT05296824 is a clinical study titled "Cryoballoon PVI With PWI Versus PVI Alone In Patients With PAF". 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...
What is the current status of trial NCT05296824?
This trial is currently completed. The enrollment target is 320 participants. The study started on 2014-01-01. Estimated completion is 2021-12-31.
What conditions does trial NCT05296824 study?
This clinical trial studies the following conditions: Paroxysmal Atrial Fibrillation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05296824?
The interventions under investigation include: Cryoballoon ablation for the treatment of atrial fibrillation (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05296824?
This trial is sponsored by Sacramento EP Research, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05296824 being conducted?
This trial has 4 study locations across California, Colorado, Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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