Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05296824 · ClinicalTrials.gov registry record
Cryoballoon PVI With PWI Versus PVI Alone In Patients With PAF
A clinical trial of Paroxysmal Atrial Fibrillation, sponsored by Sacramento EP Research.
- Completed
- Registry status
- 320
- Enrollment target
- 4
- Study locations
NCT05296824: Completed study of Paroxysmal Atrial Fibrillation, sponsored by Sacramento EP Research.
NCT05296824 is a study of Paroxysmal Atrial Fibrillation that has completed, run by Sacramento EP Research. The registered enrollment target is 320 participants, below the 846-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (62% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05296824, a study of Paroxysmal Atrial Fibrillation, has completed, sponsored by Sacramento EP Research.
- COMPLETED
- Registry status
- 320 participants
- Enrollment target
- 4
- Study locations
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.
Primary Outcome
The recurrence of atrial fibrillation following PVI+PWI versus PVI alone using cryoballoon ablation in patients with symptomatic paroxysmal atrial fibrillation during long-term follow-up greater than 3 years.
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 |
What the finished NCT05296824 record still lists
NCT05296824 is an observational study that tracks outcomes without assigning an intervention. The registered 320 participants enrollment target is mid-sized for trials with a published cap, below the 846-participant average among 24 other Paroxysmal Atrial Fibrillation trials with a reported enrollment target (62% lower).
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.
NCT05296824 reports a single indexed study location in California, Colorado, Massachusetts.
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.
What interventions are being tested in trial NCT05296824?
The interventions under investigation include: Cryoballoon ablation for the treatment of atrial fibrillation (PROCEDURE).
Who is sponsoring clinical trial NCT05296824?
This trial is sponsored by Sacramento EP Research, which has 1 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Paroxysmal Atrial Fibrillation
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05296824's enrollment target sits among peer trials
320 8th of 24 higher than 17 of 24 other Paroxysmal Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Paroxysmal Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
ULTRA-HFIB-Redo: Ultrasound-based Renal Sympathetic Denervation vs Control in Redo Ablation Patients
RECRUITING · NA
-
Determinates of Atrial Tracking and Prevalence of Atrial Fibrillation in the Micra AV2 (DANCE AFIB)
RECRUITING
-
STOP AF First Post-Approval Study
RECRUITING
-
The Long-term Safety and Effectiveness Evaluation of the QDOT MICRO System Use in Conjunction With VISITAG SURPOINT Module for the Treatment of Symptomatic Drug Refractory Paroxysmal Atrial Fibrillation.
RECRUITING
-
EXercise Cardiac Magnetic Resonance Assessment of Left Atrial Mechanics Following Ablation
RECRUITING
-
Biomarker-Guided Optimization of Transcutaneous Vagal Stimulation for Atrial (BiG tVNS-AF)
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02763683 · 320 participants
Investigations of Dementia in Parkinson Disease
- NCT03331198 · 320 participants · Phase 1
Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
- NCT03458832 · 320 participants
Clinical Trial Readiness to Solve Barriers to Drug Development in FSHD
- NCT03551951 · 320 participants
Tumor Cell and DNA Detection in the Blood, Urine, and Bone Marrow
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI