Clinical Trials

An Evolut™ EXPAND TAVR II Pivotal Trial

Rochester, MN

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An Evolut™ EXPAND TAVR II Pivotal Trial

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is to obtain safety and effectiveness data to support indication expansion for the Medtronic transcatheter aortic valve replacement (TAVR) System to include patients with moderate, symptomatic Aortic Stenosis (AS).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 22-004293
NCT ID:
NCT05149755
Sponsor Protocol Number:
D00411092

ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

Rochester, MN

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ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

Location:
Interventional
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is to establish the safety and effectiveness of the Edwards SAPIEN X4 Transcatheter Heart Valve (THV) in subjects with symptomatic, severe, calcific aortic stenosis (AS).

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 22-004385
NCT ID:
NCT05172960
Sponsor Protocol Number:
2021-05

International Bicuspid Aortic Valve Consortium (BAVCon)

Rochester, MN

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International Bicuspid Aortic Valve Consortium (BAVCon)

Location:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

Bicuspid aortic valve (BAV) disease is the most frequent congenital cardiac malformation, occurring in 0.5-1.2% of the US population. In young adults, it is generally a benign abnormality; but in older adults it is associated with thoracic aortic aneurysm or dissection in 20-30% of those with BAV. BAV is strongly associated with early development of aortic valve calcification or incompetence in >50% of BAV patients, and accounts for ~40% of the >30,000 aortic valve replacements (AVR) performed in the US each year. Yet, we know little of the etiology, cellular events and modifiers of progression of BAV to calcific aortic valve disease and we still do not understand the genetic cause(s) of BAV despite evidence for its high heritability.

The Specific Aims of this study are:

1. To identify the genetic causes of bicuspid aortic valve disease and its associated thoracic aortic disease.

2. To identify potential pathways to predict the clinical course of BAV disease and for treating human BAV disease.

To achieve these aims, we have created the International Bicuspid Aortic Valve Consortium (BAVCon), a consortium of institutions with cohorts of BAV patients and the expertise to fulfill the performance of these aims.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Open for enrollment	View complete study & contact information

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Site IRB:
- Rochester, Minnesota: 14-005324
NCT ID:
NCT01980797
Sponsor Protocol Number:
2013P000260

A Study to Evaluate Proximal Aortic Seal Zone Stress and Strain Following Endovascular Aortic Repair

Jacksonville, FL

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A Study to Evaluate Proximal Aortic Seal Zone Stress and Strain Following Endovascular Aortic Repair

Location:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is to obtain baseline stress and strain of abdominal aortic artery prior to endovascular repair, and to compare the variation in stress and strain of Ovation vs. Cook stent grafts immediately post-operativelythen after 1 month, 3 months, 6 months, and 12 months following endovascular repair.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla.	Contact us for the latest status	View complete study & contact information

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Site IRB:
- Jacksonville, Florida: 19-012033
Sponsor Protocol Number:
19-012033

A Study to Evaluate Aortic Dilatation in Patients with Conotruncal Abnormalities

Rochester, MN

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A Study to Evaluate Aortic Dilatation in Patients with Conotruncal Abnormalities

Location:
Observational
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.

About this study

The purpose of this study is to assess operative and postoperative outcomes after aortic valve surgery, evaluate for changes in ascending aorta diameter by comparing pre-operative CT imaging to measurements on follow-up imaging, and examine late outcomes and functional status during the follow-up period with specific focus on mortality, need for re-operation and incidence of aortic dissection.

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location	Status	Contact
Rochester, Minn.	Contact us for the latest status	View complete study & contact information

Print study details

Site IRB:
- Rochester, Minnesota: 20-004723

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Search Results 1-5 of 5 for

An Evolut™ EXPAND TAVR II Pivotal Trial

ALLIANCE: Safety and Effectiveness of the SAPIEN X4 Transcatheter Heart Valve

International Bicuspid Aortic Valve Consortium (BAVCon)

A Study to Evaluate Proximal Aortic Seal Zone Stress and Strain Following Endovascular Aortic Repair

A Study to Evaluate Aortic Dilatation in Patients with Conotruncal Abnormalities

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