The Impact of Expandable Cryoballoon on Autonomic Control of the Heart

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

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-10

Study Completion Date

2026-12-31

Brief Summary

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

Approximately 40% of patients following cryoballoon ablation show signs of parasympathetic denervation. The presence of such effect is related to better outcomes in terms of clinical efficacy (freedom from atrial fibrillation). It could be hypothesized that larger sized balloon (POLARxFIT system) because of more antral position within the left atrium (and hence smaller distance from ganglionated plexi) might enhance this beneficial modulation of the autonomic system of the heart. This study intends to compare the effects of cryoablation employing expandable balloon (POLARxFIT) vs. standard balloon (POLARx) on autonomic system of the heart.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vagal Response and Cardiac Autonomic Modulation. Insides From Cryoballoon Ablation

NCT04896424

Vagal Nerve Stimulation Autonomic Nervous System Catheter Ablation

COMPLETED NA

POLish Registry of CArdioneuroablation and CArdioneuromodulation

NCT07196397

Vasovagal Syndrome VVS Cardioinhibitory Carotid Sinus Syndrome CSS Symptomatic Sinus Bradycardia SB or Atrioventricular Block AV +9 more

RECRUITING

Repolarization and Activation Mapping in Ventricular Tachycardia Ablation: the REDEMPTION Study

NCT06765746

Ventricular Tachycardia Ablation

NOT_YET_RECRUITING

Assessment of the Durability of Cardioneuroablation Using Physiological Indices of Heart Rate Reactivity

NCT06697145

Syncope, Vasovagal, Neurally-Mediated

COMPLETED NA

Ventricular Tachycardia in Ischemic Cardiomyopathy; a Combined Endo-Epicardial Ablation Within the First Procedure Versus a Stepwise Approach

NCT02358746

Ventricular Tachycardia Ischemic Cardiomyopathy

UNKNOWN NA

Detailed Description

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

Conditions

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

Paroxysmal 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

SINGLE

Participants

Study Groups

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

expandable cryoballoon

POLARxFIT

Group Type EXPERIMENTAL

cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)

Intervention Type DEVICE

first applications in LSPV and RSPV are done with 31 mm balloon

standard cryoballoon

POLARx

Group Type EXPERIMENTAL

cryoablation of atrial fibrillation using only 28 mm size balloon

Intervention Type DEVICE

all applications in all PVs are done with 28 mm balloon

Interventions

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

cryoablation of atrial fibrillation using only 28 mm size balloon

all applications in all PVs are done with 28 mm balloon

Intervention Type DEVICE

cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)

first applications in LSPV and RSPV are done with 31 mm balloon

Intervention Type DEVICE

Eligibility Criteria

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

Inclusion Criteria

* primary PVI
* paroxysmal atrial fibrillation
* sinus rhythm at the admission
* participant meets clinical criteria for PVI

Exclusion Criteria

* LA diameter \<38 mm or \>50 mm
* LVEF \<40%
* intrinsic sinus node disease
* advanced atrioventricular block (PR interval \>300 ms, II or III degree AV block)
* previous cardioneuroablation procedure
* pregnancy
* contraindications to anticoagulation treatment
* any other clinical contraindications to PVI
* known atropine intolerance

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No