Last reviewed · How we verify
NCT03587181: SubstrateAF
Investigation of Substrates Associated With the Recurrence of Atrial Fibrillation After PV Cryoablation
trial testing Cryoablation of the pulmonary veins and myocardial biopsy in Atrial Fibrillation in 100 participants. Completed in 30 October 2019.
30 October 2019
Quick facts
| Lead sponsor | National Research Center for Preventive Medicine |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 3 April 2017 |
| Primary completion | 30 October 2019 |
| Estimated completion | 30 October 2019 |
| Sites | 1 location across Russia |
Drugs / interventions tested
- Cryoablation of the pulmonary veins and myocardial biopsy
Conditions studied
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
Sponsor
National Research Center for Preventive Medicine
Who can join
Adults 18 to 80, any sex, with Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The two main mechanisms for atrial fibrillation (AF) recurrence after cryoablation include Pulmonary vein (PV) reconnection and the presence of non-PV associated arrhythmic focuses. The aim of this study is to investigate the prevalence of each mechanism and if biomarkers may be used to predict of these events. Eighty patients with paroxysmal or persistent AF will undergo PV isolation with cryoablation followed by loop recorder implantation. Patients in whom atrial tachyarrhythmias recur during 12 months follow-up (outside of the 3-month post procedure blanking window) will be offered a second electrophysiology study (EP) study to assess PV isolation and non-PV focuses and further ablation performed as required. At baseline blood samples will be taken to investigate the correlation between specific biomarkers and both the incidence and type of recurrence. The correlation between recurrence of atrial tachyarrhythmias due to non-PV associated arrhythmic focuses and elevated baseline levels of NT-ProBNP, CRP, TNF, MMP1 will be pre-specified. 40 consecutive patients will have a biopsy taken from the intraventricular and interatrial septum to investigate the correlation between myocardial inflammation, the presence of fibrosis and recurrence of atrial tachyarrhythmias. Correlation between biomarkers of inflammation and biopsy-proven myocardial inflammation or fibrosis will be assessed.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
The predictive role of early recurrences of atrial arrhythmias after pulmonary vein cryoballoon ablation. Is blanking period an outdated concept? Insights from 12-month continuous cardiac monitoring.
Davtyan KV, Topchyan AH, Brutyan HA, Kalemberg EN, et al · · 2021 · cited 10× · PMID 34620082 · DOI 10.1186/s12872-021-02300-2 -
Does cryoballoon ablation affect the symptom severity of atrial fibrillation? Insights from 12-months continuous cardiac monitoring.
Davtyan K, Topchyan A, Brutyan H, Kalemberg E, et al · · 2025 · PMID 41013270 · DOI 10.1186/s12872-025-05134-4
Verify or expand the search:
- PubMed search for NCT03587181
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Atrial Fibrillation
Currently open trials in the same condition.
- NCT07429214 — A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF · NA · recruiting
- NCT07271238 — Feasibility Study on the VERAFEYE Imaging and Navigation System for Guided Catheter Ablation Procedures · NA · recruiting
- NCT07388108 — Atrial Dyssynchrony to Predict Arrhythmias in the Postoperative Setting of Cardiovascular Surgery. · recruiting
- NCT07428967 — AV Node Ablation and CONDUCTion System Pacing for Atrial Fibrillation With Preserved Left Ventricular Function · NA · recruiting
- NCT06650995 — AlEX-DHF: Ablation and Exercise in Diastolic Heart Failure · NA · recruiting
Other National Research Center for Preventive Medicine trials
Trials by the same sponsor.
- NCT04408612 — Dyspnea in Stable Patients With Coronary Artery Disease. · completed
- NCT04522076 — Prospective Hospital Registry of Patients With Suspected or Confirmed Coronavirus Infection (COVID-19) and Community-acq · active not recruiting
- NCT04400500 — Differential Diagnosis and Risk Stratification in Patients With Suspected NSTEACS · completed
- NCT04262583 — Assessment of adherenCe tO Medical theraРy and Its infLuence on Long-term Outcomes In pAtieNts With Heart Failure · completed
- NCT03883282 — Influence of Participation in Randomized Controlled Trials on adheRence to Medicines' Intake and regUlar viSits to the d · completed
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 NCT03587181 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Research Center for Preventive Medicine
- Last refreshed: 13 January 2020
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/NCT03587181.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing