This is an exploratory research aiming to accurately identify the site of origin of tachyarrhythmia using Magnetocardiography (MCG), which will have guiding significance for early diagnosis, the formulation of treatment plans and preoperative positioning for radiofrequency ablation.

开始日期2024-03-14

申办/合作机构

Qilu Hospital of Shandong University

NCT05763953 / Recruiting临床2期

The NODE-202 Study Multi-Center, Multi-National, Open-Label, Efficacy and Safety Study of Etripamil Nasal Spray in Pediatric Patients With Paroxysmal Supraventricular Tachycardia

NODE-202 is a Phase 2, multicenter, multinational, single dose, open-label, 2-part, sequential design study in pediatric patients with an established diagnosis of paroxysmal supraventricular tachycardia (PSVT) presenting with a symptomatic episode of PSVT.
In Part 1, at least 30 patients aged 12 to <18 years will be enrolled and treated with etripamil nasal spray (NS). Efficacy, safety, tolerability and PK (for at least 12 patients) will be assessed after administration of 70 mg etripamil NS (Part 1A). At least 18 subsequent patients will be enrolled and treated with the etripamil NS with the dose determined by the Pharmacokinetic (PK) analysis and will undergo efficacy and safety/tolerability assessments (Part 1B).
In Part 2, at least 30 patients aged 6 to <12 years will be enrolled and treated with etripamil NS at a dose selected based on appropriate body size-based modeling, as well as efficacy, safety/tolerability, and PK data collected in Part 1. Efficacy, safety, tolerability and PK (for at least 12 patients) will be assessed after administration of etripamil NS (Part 2A). At least 18 subsequent patients will be enrolled and treated with the etripamil NS with the dose determined by the PK analysis and will undergo efficacy and safety/tolerability assessments (Part 2B).
The study will include the following visits: A Screening Visit, A Treatment Visit, , and A Follow-Up/End of Study Visit.

开始日期2023-12-11

申办/合作机构

Milestone Pharmaceuticals, Inc.

NCT06077799 / RecruitingN/A

prehospItal maNagement oF paroxysmaL supraventrICular Tachycardia - Gestione Preospedaliera Della Tachicardia Parossistica Sopraventricolare

Retrospective multicentre study on management of supraventricular tachycardia in prehospital setting.

开始日期2023-06-14

申办/合作机构

Azienda USL di Bologna

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项与阵发性室上性心动过速相关的文献（医药）

2024-02-24·Trials

Comparing the effects of pulsed and radiofrequency catheter ablation on quality of life, anxiety, and depression of patients with paroxysmal supraventricular tachycardia: a single-center, randomized, single-blind, standard-controlled trial.

Article

作者: Ying Du ; Shanshan Ma ; Pan Yue ; Ying Xu ; Ya Wen ; Mingzhu Ji ; Lingxiao He ; Dengbin Liao

BACKGROUND:

Radiofrequency catheter ablation (RFCA) may lead to decreased quality of life (QOL) and increased anxiety and depression in patients with paroxysmal supraventricular tachycardia (PSVT), possibly due to the lack of selectivity of the ablation tissue and the long ablation time. In recent years, pulsed field ablation (PFA) has been used for the first time in China to treat PSVT patients because of its ability to ablate abnormal tissue sites in a precise and transient manner. This study was conducted to compare the effects of PFA and RFCA on QOL and psychological symptoms of PSVT patients.

METHODS:

We have designed a single-center, randomized, single-blind, standard-controlled trial. A total of 50 participants who met the eligibility criteria would be randomly allocated into the PFA group or RFCA group in a 1:1 ratio. All participants were assessed using the 36-Item Short-Form Health Survey (SF-36) and the Hospital Anxiety and Depression Scale (HADS) at pre-procedure (T0), post-procedure (T1), and 3 months post-procedure (T2). The SPSS 21.0 software was used to analyze the data through Wilcoxon and Fisher's exact tests and repeated measures ANOVA.

RESULTS:

Twenty-five in the PFA group and 24 in the RFCA group completed the trial. SF-36: (1) Between-group comparison: At T1, PFA group had significantly higher SF-36 scores on physiological function (PF) and general health (GH) than RFCA group, with a treatment difference of 5.61 points and 18.51 points(P < 0.05). (2) Within-group comparison: We found that in the PFA and RFCA groups, T2 showed significant improvement in the remaining 6 subscales of the SF-36 scale compared to T1 and T0 (P < 0.05), except for body pain (BP) and social function (SF) scores. HADS: (1) Between-group comparison: no significant difference (P > 0.05). (2) Within-group comparison: The HADS scores of the PFA and RFCA groups were statistically significant at T2 compared to T0 and T1 (P < 0.05).

CONCLUSIONS:

Our study provided new and meaningful evidence that PFA was effective in significantly improving QOL and decreasing anxiety and depression in PFA patients.

TRIAL REGISTRATION:

Chinese Clinical Trial Registry, ChiCTR2200060272.

2024-02-15·Maternal and child health journal

Outcome of Infants Born to Women with Chronic Hepatitis B: A Local Risk-Based Strategy in a Low Prevalence Country.

Article

作者: Giannina Izquierdo Copiz ; Carolina Ibañez ; Cecilia Piñera ; Luis Cordova ; Ernesto Payá ; Paula Leal ; Rodolfo Villena

BACKGROUND:

Chronic hepatitis-B virus (HBV) infection due to mother-to-child transmission (MTCT) during the perinatal period is an important global health concern. Chile is a low-prevalence country with an increasing migratory inflow from Latin- American countries, with intermediate to high endemic rates of HBV infection, and until 2021, there is no universal maternal screening. This study aimed to evaluate infant outcomes using a risk-based strategy of maternal screening to prevent MTCT of hepatitis B virus (HBV) in a low-prevalence country.

METHODS:

This prospective study included infants born to HBsAg-positive women detected using a local risk-based strategy. The exposed infants received immunoprophylaxis (IP) and follow-up to evaluate their clinical outcomes and immune responses through post-serological vaccine testing (PSVT) after completing the three- dose schedule of the HBV vaccine.

RESULTS:

A total of 99 HBsAg-positive mothers were detected. Seventy-six (82%) infants completed the follow-up and had PSVT between 9 and 12 months of age. 55.2% female, the median gestational age was 39 weeks (25-41) and the median birth weight was 3,130g (816-4,400 g). All patients received IP with recombinant HBV vaccine plus hepatitis-B virus immunoglobulin (HBIG) and three doses of the HBV vaccine. There were no cases of HBV infection, and 96% (72) responded to immunization with HBsAg antibodies (anti-HBsAg) >10 UI/ml, with a median level of 799 IU/ml.

CONCLUSIONS:

A high-risk strategy can be implemented in countries with non-universal screening for VHB. Timely IP plus high-uptake VHB vaccination in infants born to HBsAg-positive mothers was associated with a high immunogenic response and absence of MTCT.

2024-02-13·Pacing and clinical electrophysiology : PACE

Cannon A wave validation as a diagnostic tool in paroxysmal supraventricular tachycardias.

Article

作者: David González-Casal ; Alberto Pérez-Castellanos ; Nina Soto Flores ; Alejandro Carta-Bergaz ; Esteban González-Torrecilla ; Vanesa Bruña Fernández ; Pablo Ávila ; Felipe Atienza ; Ángel Arenal ; Jorge González-Panizo ; Francisco Fernández-Avilés ; José Angel Cabrera ; Tomás Datino

OBJECTIVE:

The presence of cannon A waves, the so called "frog sign", has traditionally been considered diagnostic of atrioventricular nodal re-entrant tachycardia (AVNRT). Nevertheless, it has never been systematically evaluated. The aim of this study is to assess the independent diagnostic utility of cannon A waves in the differential diagnosis of supraventricular tachycardias (SVTs).

METHODS:

We prospectively included 100 patients who underwent an electrophysiology (EP) study for SVT. The right jugular venous pulse was recorded during the study. In 61 patients, invasive central venous pressure (CVP) was registered as well. CVP increase is thought to be related with the timing between atria and ventricle depolarization; two groups were prespecified, the short VA interval tachycardias (including typical AVNRT and atrioventricular reciprocating tachycardia (AVRT) mediated by a septal accessory pathway) and the long VA interval tachycardias (including atypical AVNRT and AVRT mediated by a left free wall accessory pathway).

RESULTS:

The relationship between cannon A waves and AVNRT did not reach the statistical significance (OR: 3.01; p = .058); On the other hand, it was clearly associated with the final diagnosis of a short VA interval tachycardia (OR: 10.21; p < .001). CVP increase showed an inversely proportional relationship with the VA interval during tachycardia (b = -.020; p < .001). CVP increase was larger in cases of AVNRT (4.0 mmHg vs. 1.2 mmHg; p < .001) and short VA interval tachycardias (3.9 mmHg vs. 1.2 mmHg; p < .001).

CONCLUSION:

The presence of cannon A waves is associated with the final diagnosis of short VA interval tachycardias.

项与阵发性室上性心动过速相关的新闻（医药）

2024-04-03

·GlobeNewswire-Health Care

Milestone® Pharmaceuticals to Present at the 23rd Annual Needham Healthcare Conference

MONTREAL and CHARLOTTE, N.C., April 03, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) today announced that members of its management team will deliver a company presentation at the 23rd Annual Needham Virtual Healthcare Conference on April 10, 2024 at 8:45 am ET. The webcast is available to watch both live and replay for approximately 90 days following the presentation in the News & Events section of Milestone’s website. www.milestonepharma.com About Milestone PharmaceuticalsMilestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular solutions to improve the lives of people living with complex and life-altering heart conditions. The Company’s focus on understanding unmet patient needs and improving the patient experience has led us to develop new treatment approaches that provide patients with an active role in self-managing their care. Milestone’s lead investigational product is etripamil, a novel calcium channel blocker nasal spray that is being studied for patients to self-administer without medical supervision to treat highly symptomatic episodic attacks associated with PSVT and AFib-RVR. Contact:Kim Fox, Vice President, Communications, kfox@milestonepharma.com Investor RelationsChris Calabrese, ccalabrese@lifesciadvisors.comKevin Gardner, kgardner@lifesciadvisors.com

AHA会议

2024-04-01

·GlobeNewswire-Health Care

Milestone® Pharmaceuticals to Present Data on Etripamil at the American College of Cardiology and European Heart Rhythm Association Annual Conferences

MONTREAL and CHARLOTTE, N.C., April 01, 2024 (GLOBE NEWSWIRE) -- Milestone® Pharmaceuticals Inc. (Nasdaq: MIST) a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced that it will present data on etripamil at two upcoming cardiology conferences this month. The company will deliver oral and poster presentations at the American College of Cardiology annual meeting (ACC24), to be held April 6-8th in Atlanta, Georgia, and a poster presentation at the annual meeting of the European Heart Rhythm Association (EHRA), to be held April 7-9th in Berlin, Germany. The presentations will be available following the embargo at https://MilestonePharma.com. ACC Presentation Details: Oral Presentation Title: Multi-Center, Open-Label Study of the Efficacy and Safety of Etripamil Nasal Spray Self-Administered For Multiple Episodes of Symptomatic Supraventricular Tachycardia Without Supervision (Phase 3, NODE-303)Presenter: James Ip, M.D., Professor and Director of Cardiac Pacing and Implantable Devices, Division of Cardiology, Weill Cornell Medicine, New York Presbyterian HospitalDate and time: Monday, April 8, 2024, 11:36 – 11:46 a.m. EDT Poster Presentation Title: Symptom-prompted, Self-administered Intranasal Etripamil for Termination of Paroxysmal Supraventricular Tachycardia in the RAPID Study: Relationship Among Etripamil-Induced Reduction in Tachycardia Rates, Conversion to Sinus Rhythm, and Improvement in Patient SymptomsPresenter: James Ip, M.D., Professor and Director of Cardiac Pacing and Implantable Devices, Division of Cardiology, Weill Cornell Medicine, New York Presbyterian HospitalDate and time: Sunday, April 7, 2024, 12:15 – 1:00 p.m. EDT EHRA Presentation Details: Poster Presentation Title: Characterising paroxysmal supraventricular tachycardia episodes by patient-perceived episode duration, symptoms, and severity: longitudinal patient-reported outcomesPresenter: David Bharucha, M.D., Ph.D., FACC, Chief Medical Officer of Milestone Pharmaceuticals, Inc.Date and time: Sunday, April 7, 2024, 10:15 a.m. CET About Milestone Pharmaceuticals Milestone Pharmaceuticals Inc. (Nasdaq: MIST) is a biopharmaceutical company developing and commercializing innovative cardiovascular solutions to improve the lives of people living with complex and life-altering heart conditions. The Company’s focus on understanding unmet patient needs and improving the patient experience has led us to develop new treatment approaches that provide patients with an active role in self-managing their care. Milestone's lead investigational product is etripamil, a novel calcium channel blocker nasal spray that is being studied for patients to self-administer without medical supervision to treat highly symptomatic episodic attacks associated with PSVT and AFib-RVR. Contact: Kim Fox, Vice President, Communications kfox@milestonepharma.com Investor Relations Chris Calabrese, ccalabrese@lifesciadvisors.com Kevin Gardner, kgardner@lifesciadvisors.com

AHA会议临床3期

2024-03-28

·FierceBiotech

Milestone resubmits new drug application while Aldeyra readies similar 2nd-chance filing

Milestone Pharmaceuticals' resubmitted NDA package for etripamil is critical for a second, larger indication. Milestone Pharmaceuticals has resubmitted a new drug application to the FDA, with Aldeyra Therapeutics readying a similar ask for the second half of the year. The regulatory updates disclosed Thursday offer a glimmer of hope to two biotechs trying to rebound from previous NDA misses. Milestone is the first to give it another go, resubmitting an application for etripamil, a self-administered nasal spray to treat paroxysmal supraventricular tachycardia (PSVT), a type of abnormal heart rhythm. The biotech received a refuse-to-file letter in late December 2023 after regulators deemed the application insufficient for review and asked for additional information on the timing of side effect data. The company said at the time that the FDA didn’t express concern about the side effects themselves. “We believe we have addressed all the issues raised in the Refusal to File letter and look forward to working with the agency as it reviews our application,” President and CEO Joseph Oliveto said in Thursday’s release. The resubmission is made more critical by its impact on etripamil’s second and larger indication, atrial fifibrillation with rapid ventricular response. Milestone said in a fourth-quarter earnings update that the FDA reiterated prior guidance that should the spray be approved to treat PSVT, a single atrial fibrillation study should suffice as part of a supplemental NDA to expand the indication. Milestone expects to finalize the study protocol for a registrational trial by the middle of 2024. Aldeyra is not too far behind, expecting to resubmit an application for reproxalap after being rejected in November 2023. It was hardly a surprise after the company said a month earlier that the move was anticipated. Aldeyra plans to initiate a dry eye chamber trial in the first half of 2024, which, if successful, would form the basis for a resubmitted NDA in the second half. The biotech also plans to conduct another trial at a separate dry eye chamber plus a six-week field trial in parallel with the pivotal study “as part of a comprehensive strategy designed to account for disease heterogeneity and potential differences in clinical sites and environment,” according to a release. Aldeyra reiterated that its $142.8 million in cash on hand is enough to last “beyond 2026.”