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NCT03550573: 3D-CMH
3D Non-invasive Myocardial Electrical Propagation Mapping as a New Tool to Predict Sudden Death Risk in Patients With Hypertrophic Cardiomyopathy
NA trial testing CardioInsight™ Noninvasive 3D Mapping System in Hypertrophic Cardiomyopathy in 30 participants. Completed in 23 September 2022.
23 September 2022
Quick facts
| Lead sponsor | Hospices Civils de Lyon |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 30 |
| Start date | 28 January 2019 |
| Primary completion | 23 September 2022 |
| Estimated completion | 23 September 2022 |
| Sites | 1 location across France |
Drugs / interventions tested
- CardioInsight™ Noninvasive 3D Mapping System
Conditions studied
- Hypertrophic Cardiomyopathy — all drugs for Hypertrophic Cardiomyopathy →
Sponsor
Hospices Civils de Lyon — full company profile →
Who can join
18 and older, any sex, with Hypertrophic Cardiomyopathy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Hypertrophic cardiomyopathy (HCM) is very common. The thickened heart muscle can disrupt the normal functioning of the heart's electrical system, resulting in fast or irregular heartbeats. Today, there are no reliable means to identify HCM patients at risk of sudden death. The CardioInsight™ has recently been developed by Medtronic for non-invasive advanced cardiac mapping system. The CardioInsight™ Noninvasive 3D Mapping System is a non-invasive mapping system that collects chest ECG signals and combines these signals with CT scan data to produce and display simultaneous, bi-atrial and biventricular, 3-D cardiac maps. It is a monocentric, prospective, comparative and analytical study. 20 HCM patients will be recruited in the National Reference Center for inherited cardiac diseases of Lyon. The 3D-propagation maps of 10 well phenotyped and genotyped HCM patients with previous VF (ventricular fibrillation) will be compared to 10 HCM patients without previous VF. After consent signed, Holter ECG, scanner and CardioInsightTM 3D\_ECG mapping will be planned in the month following the inclusion. 12-lead ECG, 24h holter ECG, cardiac scanner will be performed as standard procedure of each center in the current health care of the patient. The widespread screening of HCM patients with 3D high-density noninvasive mapping should improve the risk-benefit ratio of implantable defibrillator therapy. It is expected that more patients at risk will benefit from this device.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03550573
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Hypertrophic Cardiomyopathy
Currently open trials in the same condition.
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- NCT06490250 — Comparison of the Effects of Inspiratory Muscle Training and Baduanjin Exercises in Hypertrophic Cardiomyopathy Patients · NA · recruiting
- NCT06573723 — Institutional Registry of Rare Diseases · recruiting
- NCT06549608 — A Retrospective Cohort Study of Mavacamten Patient Support Program in Canada · active not recruiting
- NCT05939700 — Mavacamten Pregnancy Surveillance Program · recruiting
Other Hospices Civils de Lyon trials
Trials by the same sponsor.
- NCT07569536 — Efficacy of the Alpha 2 Agonist Dexmedetomidine for Sympathetic Deactivation in REfractory Septic Shock · Phase 3 · not yet recruiting
- NCT07529314 — Evaluating Interventional Radiology for Cancer Pain Management · NA · not yet recruiting
- NCT07273929 — Comparative Study of the Effectiveness of Three Access Routes for Implanting an Electronic Intracardiac Device · Phase 3 · not yet recruiting
- NCT07474532 — Attitudes and Beliefs Related to Benzodiazepine Deprescribing · not yet recruiting
- NCT07313007 — Assessment of Gut Microbiota-Derived Amino Acid Metabolite Production in Patients With MASLD · NA · not yet 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 NCT03550573 (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 Hospices Civils de Lyon
- Last refreshed: 18 January 2023
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/NCT03550573.
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