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NCT06053606
The Impact of Expandable Cryoballoon on Autonomic Control of the Heart
NA trial testing cryoablation of atrial fibrillation using only 28 mm size balloon in Paroxysmal Atrial Fibrillation in 100 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | Wroclaw Medical University |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 10 May 2024 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- cryoablation of atrial fibrillation using only 28 mm size balloon
- cryoablation of atrial fibrillation using expandable balloon (28 / 31 mm)
Conditions studied
- Paroxysmal Atrial Fibrillation — all drugs for Paroxysmal Atrial Fibrillation →
Sponsor
Wroclaw Medical University
Who can join
Adults 18 to 79, any sex, with Paroxysmal Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06053606
- Europe PMC full search
- ASCO Meeting Library
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Related trials
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Currently open trials in the same condition.
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- NCT07116525 — A Study Assessing Arrhythmia Mapping With a Multi-Electrode Mapping Catheter · NA · recruiting
- NCT06765356 — Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias · Phase 4 · active not recruiting
Other Wroclaw Medical University trials
Trials by the same sponsor.
- NCT07413419 — Evaluation of Remote Motivational Interviewing for Disease Management in Heart Failure Patients and Their Carers · NA · not yet recruiting
- NCT07159932 — Poland Integrated Medicines Management (PL-IMM) - Study Assessing the Provision of Complex Clinical Pharmacy Services to · NA · not yet recruiting
- NCT07141745 — Electroporation vs. Radiofrequency Ablation Guided by 3D Imaging in Repeat Procedures for Atrial Fibrillation · NA · recruiting
- NCT07099885 — Simple Urine Composition-based Personalized Algorithm for Effective Congestion Relief in Decompensated Heart Failure · NA · recruiting
- NCT07157475 — Vascular Complications in Patients Undergoing Peripheral Revascularization and Taking SGLT-2 Inhibitors · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06053606 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Wroclaw Medical University
- Last refreshed: 24 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06053606.
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