Aortic valve replacement with bioprosthesis according to indications in the current guidelines for the management of valvular heart disease including surgical closure of left atrial appendage

aortic valve replacement with bioprosthesis according to indications in the current guidelines for the management of valvular heart disease. The operation as well as the pre and post-operative care will be performed according to local surgical policies.

Surgical closure of left atrial appendage

Aortic valve replacement with bioprosthesis according to indications in the current guidelines for the management of valvular heart disease.

aortic valve replacement with bioprosthesis according to indications in the current guidelines for the management of valvular heart disease.

No closure of left atrial appendage

On the basis of standard treatment, a combined treatment plan of TCM universal treatment and syndrome-specific treatment was given.

TCM universal treatment plan:

(Intensive treatment) Chuanzhi Tongluo Capsules (Lunan Pharmaceutical), 4 capsules each time, orally, 3 times a day; administration from day 1 to day 14 of the disease.

(Sequential treatment) Chuanzhi Tongluo Capsules (Lunan Pharmaceutical), 2 capsules each time, orally, 3 times a day; administration from day 15 to day 365.

TCM decoction: Individualized herbal decoction based on TCM diagnosis (four diagnostic methods), administered for 14 days during intensive phase.

4 capsules each time, orally, 3 times a day; administration from day 1 to day 14 of the disease.

(Intensive treatment) Chuanzhi Tongluo Capsules

2 capsules each time, orally, 3 times a day; administration from day 15 to day 365.

(Sequential treatment) Chuanzhi Tongluo Capsules

Individualized herbal decoction based on TCM diagnosis (four diagnostic methods), administered for 14 days during intensive phase.

TCM Syndrome Differentiation Decoction

Guideline-based treatment for cerebral infarction with diabetes: aspirin (100 mg/day) + clopidogrel (75 mg/day) + atorvastatin (20 mg/day) + metformin (500 mg bid). Other antiplatelet/antidiabetic drugs may be added per clinician discretion.

Combination therapy including: 1. Antiplatelet: aspirin 100 mg/day + clopidogrel 75 mg/day. 2. Lipid-lowering: atorvastatin 20 mg/day. 3. Antidiabetic: metformin 500 mg bid (max 2000 mg/day). \*Doses may be adjusted per local guidelines or patient tolerance.

Standard Treatment (Guideline-Based)

Guangzhou University of Traditional Chinese Medicine

All subjects will be assigned to the XL1 Coil treatment group.

The surgeon verifies the intestinal diameter and selects the appropriate device diameter size. The device is introduced into the lumen of the intestine and advanced about 5-10cm. The surgeon uses 4-0 chromic sutures placed in the seromuscular layer to secure the XL1 Coil within the intestine. The surgeon places metal clips on proximal and distal sutures and in the mesentery adjacent to the XL1 Coil ends to mark the location for radiologic evaluation. The surgeon releases the XL1 Coil and closes the enterotomy.

Distraction Enterogenesis in Adult Patients with Short Bowel Syndrome

Shweta Namjoshi, MD

Matthew Lin, MD

Anisha Abreo

Joseph Forrester, MD

Clarivet Torres, MD

Meghan Fitzgerald

Mark Puder, MD

Beth Cobb

Michael Helmrath, MD

Paul Wales, MD

다운증후군 아동을 대상으로 2개월간 드럼 레슨이 자기 통제력과 타이밍 기술 향상에 미치는 영향을 연구하는 시험입니다.

Experimental group will receive the drumming lesson intervention between baseline and testing approximately 2 to 3 months later, so the effects of the intervention can be assessed in the lab measures.

Drumming lessons consisting of how to use hands to drum on djembe drum, using alternating hands to drum, drumming to a metronome and to music.

2 months of drumming lessons given by a professional drummer with extensive experience working with children with Down syndrome

Children in the Control condition will receive drumming lessons only after they have completed lab baseline and testing measures, about 2 to 3 months later.

Receiving lessons after the two lab visits should still offer any possible positive effects to participants while still allowing us to compare the Control group children's behaviors to those of the Experimental group.

Lessons after measurement

실험군은 기준선과 시험 사이에 약 2~3개월 후에 드럼 연주 레슨 개입을 받게 되므로, 실험실 측정을 통해 개입의 효과를 평가할 수 있습니다.

다운증후군 아동을 대상으로 광범위한 경험을 쌓은 전문 드러머가 제공하는 2개월간의 드럼 레슨

통제 조건에 있는 어린이는 실험실 기준선과 시험 측정을 완료한 후 약 2~3개월 후에만 드럼 레슨을 받게 됩니다.

측정 후의 교훈

Caroline Danforth, MS

Alison Rubin, BA

Amy Needham, PhD

Miriam Lense, PhD

드럼 레슨이 다운증후군 아동에게 미치는 영향

Patients with elevated mean PAP (mean PAP ≥ 30 mmHg) and randomized to the HM3 group will receive the device within 14 days of randomization.

The CardioMEMS™ HF System is comprised of a lead-less and battery-less pressure sensor which remotely transmits pulmonary artery pressure measurements.

CardioMEMS HF System

The HeartMate 3 LVAS is a mechanical circulatory support pump with Full MagLev Technology that assumes some or all of the workload of the left ventricle. The HeartMate 3 LVAS is used in advanced heart failure patients needing short or long-term mechanical circulatory support.

HeartMate 3 Left Ventricular Assist System

Optimal doses of medical therapy per established heart failure guidelines which includes the following stable combination of Beta Blockers, ACE-inhibitors or ARB or ARNi, MRA and SGLT2 inhibitors.

Guideline Medical Directed Therapy

Patients with elevated mean PAP (mean PAP ≥ 30 mmHg) and randomized to the control group will continue their medical therapy per established heart failure guidelines.

Patients who do not meet the mean PAP threshold (mean PAP \<30 mmHg) and are enrolled in the single arm will continue their medical therapy per established heart failure guidelines.

Julia Riebandt, MD, PhD

Daniel Zimpfer, MD

Ivan Netuka, MD

Christina Moeller

Kasper Rossing, MD

Victoria Himstedt

Michael Borger, MD

Antje Juergens

Dominik Berliner, MD

Annegret Schneider

Felix Schoenrath, MD

Giuditta Cuccuru

Antonino Loforte, MD

Nico Van Den Berg

Rudolf De Boer, MD

Manon Kuikhoven

Linda Van Laake, MD

Joud Hewaidi

Mohammed Alreshidan, MD

Luluah Altukhaifi

Jehad Abdulhamid Al Buraiki, MD

Abisola Akinbobola

Radha Gopalan, MD

Victoria Marren

Patrick Campbell, MD

Jessica Mccall

Michael Gibson, MD

Tyre Richardson

Shweta Motiwala, MD

Hellina Birru

Sheikh Farooq, MD

Erikson Walter

Mustafa Ahmed, MD

Maria Mejia-Gomez

Mauricio Velez, MD

Andrew Bailey

Catherine Marti, MD

Jennifer Hansen

Darshak Karia, MD

Amuthanayaki Kanagaraj

Abdul Bikak, MD

Mairead Delaney

Vinh Chau, MD

Regina Margiotti

Ashwin Ravichandran, MD

Terry Christenson

Zubair Shah, MD

Brianna Grimm

Emma Birks, MD

Bronwen Rees-Weidemann

Erin Coglianese, MD

Zack Malouf

Lindsey Aurora, MD

Stephanie Hanson

Matthew Gonzalez, MD

Kate Jappe

Mosi Bennett, MD

Colleen Irlbeck

Andrew Rosenbaum, MD

Amanda Huffman

Timothy Fendler, MD

Ryan Ruskamp

Adam Burdorf, DO

Salome Reddy

Maria Avila, MD

Jessica Idumonyi

Nir Uriel, MD

Lori Caufield

Leway Chen, MD

Hanna Mixon

William Mostertz, MD

Dana Amaro

Sanjeev Gulati, MD

Susanne Pasley

Emani Sitaramesh, MD

Barbara Gus

Michael Tong, MD

Jill Bethany Fife

Luke Cunningham, MD

Allyson O'Guin

Luis David Meggo Quiroz, MD

Ricardo Mendoza

Christopher Chien, MD

Colleen Marchand

Donald Haas, MD

Amanda Donnangelo

John Boehmer, MD

Laurie Machen

Matthew Lander, MD

Melissa Lamicq

Arman Kilic, MD

Abigail Anderson

Brooks Ferguson

James Ampadu, MD

Rishi Bhula

Dmitry Yaranov, MD

Jennifer Mcsorley

Raymond Bietry, MD

Shelby Shull

Cesar Guerrero-Miranda, MD

Wajeeha Abrar

Ajith Nair, MD

Mary Kelly

Cindy Martin, MD

Shelby McCoy

Aasim Afzal, MD

Rohini Bagewadi

Jaime Hernandez-Montfort, MD

Ashley Elmer

Craig Selzman, MD

Don Lobacz

Nasir Sulemanjee, MD

Lymphoma and sarcoma cancer survivors will be seen at one time point, 1 year after completion of anthracycline-based therapy.

All participants receive a standard 12-lead ECG when they present for follow-up 1 year after completion of anthracycline-based therapy. All participants will also record a 6-lead Kardia (AliveCor, Mountain View, CA, USA) and 1-lead Apple Watch (Apple, Cupertino, CA, USA) ECG with Mayo-owned or participant-owned devices.

Longitudinal participants will receive an Apple Watch to use during this study if they do not have their own (and agree to download the app) and will be able to transmit ECGs anytime anywhere from their Apple Watch from before the initiation, all through the treatment, up to 1-year after anthracycline-based therapy. For validation, these participants will transmit ECGs from their smart watch at the time of routine follow-up visits (at 3-, 6- \& 9-months post therapy visits) along with 6-lead Kardia ECGs, and 12-lead standard ECGs.

Electrocardiogram

All participants will have an echocardiogram as part of standard of care when they present for their follow-up 1 year after completion of anthracycline-based therapy.

Echocardiogram

Participants will undergo a limited LVEF echocardiogram at the 6-month post therapy visit.

LVEF echocardiogram

Biospecimen collection

Participants fill out 2 questionnaires: 1) the Kansas City Cardiomyopathy-12 (KCCQ-12) Questionnaire, and 2) the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) ore 30 (EORTC QLQ-C30) to evaluate health related quality of life and heart failure symptoms.

Questionnaires

Lymphoma and sarcoma cancer survivors will be seen before the start of anthracycline-based therapy and followed every three months up to 1 year after completion of therapy. Longitudinal participants will have the option of recording ECG and cardio fitness data through an Apple Watch from before up to 1 year post anthracycline treatment.

Longitudinal participants will receive an Apple Watch to use during this study if they do not have their own (and agree to download the app) and will be able to transmit ECGs anytime anywhere from their Apple Watch from before the initiation, all through the treatment, up to 1-year after anthracycline-based therapy. For validation, these participants will transmit ECGs from their smart watch at the time of routine follow-up visits (at 3-, 6- \& 9-months post therapy visits) along with 6-lead Kardia ECGs, and 12-lead standard ECGs.

Longitudinal participants will be asked to transmit weekly cardio fitness (estimates of peak VO2) from baseline to 1-year post therapy.

Apple Watch

Undergo CPET to assess the response of heart and lungs to exercise.

Cardio-pulmonary exercise test

Complete a 6MWT, to see how far participants can walk on a hard, flat surface for 6 minutes

6 minute walk test

A hand-held device called a dynamometer will be used to measure the muscle strength in hand/forearm

Grip strength test

Tera Peck

Clinical Trials Referral Office

Joerg Herrmann, MD

좌심방 부속기의 수술적 폐쇄, 좌심방 부속기 폐쇄 없음

(집중치료) 천지동락캡슐, 표준치료(지침기반), (순차치료) 천지동락캡슐, 중의학 증후군 감별탕

단장증후군 성인 환자의 분산성 장내생성

드럼 레슨이 다운증후군 아동에게 미치는 영향

CardioMEMS HF 시스템, HeartMate 3 좌심실 보조 시스템, 가이드라인 의료 지시 치료

심전도, 심초음파, 좌심실 구심초음파, Apple Watch, 생체 시료 채취, 설문지, 심폐 운동 검사, 6분 보행 검사, 악력 검사