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NCT04442113: ROC-STAR
RandOmised Controlled Trial of STAR Mapping™ Guided Ablation for AF.
NA trial testing Pulmonary vein isolation plus ablation guided by novel STAR mapping™ in Atrial Fibrillation. Withdrawn.
1 September 2022
Quick facts
| Lead sponsor | Rhythm AI Ltd |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 December 2021 |
| Primary completion | 1 September 2022 |
| Estimated completion | 1 September 2022 |
Drugs / interventions tested
- Pulmonary vein isolation plus ablation guided by novel STAR mapping™
- Pulmonary vein isolation
Conditions studied
- Atrial Fibrillation — all drugs for Atrial Fibrillation →
Sponsor
Rhythm AI Ltd
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
Atrial fibrillation (AF) is the most common arrhythmia with an expected rise in prevalence over the next decade. Beyond causing troublesome symptoms AF is associated with increased mortality and morbidity. Catheter ablation is a safe treatment which is effective for paroxysmal AF but the success rate for persistent AF remains approximately 50% at 1 year. A new mapping technique, called Stochastic Trajectory Analysis of Ranked signals (STAR Mapping™) Method, has recently been developed. In a pilot study, localised sources driving AF were consistently mapped and ablated with excellent acute and long term outcomes. This trial will test the clinical effectiveness of this approach by comparing conventional ablation with pulmonary vein isolation (PVI) to PVI plus STAR mapping™ guided ablation. We plan to test this through a prospective multicenter randomized controlled trial including 177 patients.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Ablation guided by STAR-mapping in addition to pulmonary vein isolation is superior to pulmonary vein isolation alone or in combination with CFAE/linear ablation for persistent AF.
Honarbakhsh S, Schilling RJ, Providencia R, Dhillon G, et al · · 2021 · cited 6× · PMID 33368766 · DOI 10.1111/jce.14856 -
Transcatheter options for atrial fibrillation treatment: an overview of the ablative techniques currently available and future perspectives.
Penela D, Falasconi G, Zucchelli G. · · 2024 · cited 3× · PMID 38380136 · DOI 10.21037/acs-2023-afm-0060 -
Future Directions for Mapping Atrial Fibrillation.
Zaman JA, Grace AA, Narayan SM. · · 2022 · cited 2× · PMID 35734143 · DOI 10.15420/aer.2021.52
Verify or expand the search:
- PubMed search for NCT04442113
- 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
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 NCT04442113 (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 Rhythm AI Ltd
- Last refreshed: 14 April 2021
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/NCT04442113.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing