Clinical Trials

A Study to Assess the Feasibility of Combining Clinically- indicated MitraClip Transcatheter Mitral Valve Repair (TMVR) and Watchman Left Atrial Appendage Occlusion (LAAO)

Rochester, MN

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A Study to Assess the Feasibility of Combining Clinically- indicated MitraClip Transcatheter Mitral Valve Repair (TMVR) and Watchman Left Atrial Appendage Occlusion (LAAO)

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

This investigation constitutes a feasibility study involving assessing the safety and feasibility of combining clinically indicated Left Atrial Appendage Occlusion (LAAO) and Transcatheter Mitral Valve Repair (TMVR) in one setting using approved devices.

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: 20-007047

The ENCIRCLE Trial

Rochester, MN

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The ENCIRCLE 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 establish the safety and effectiveness of the SAPIEN M3 System in subjects with mitral regurgitation (MR) who are at high surgical risk.

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: 20-001382
NCT ID:
NCT04153292
Sponsor Protocol Number:
4.0

Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation

Rochester, MN

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Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation

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 evaluate the safety and effectiveness of the Tendyne™ Mitral Valve System for the treatment of patients with symptomatic, moderate-to-severe or severe mitral regurgitation or for patients with symptomatic mitral valve disease due to severe mitral annular calcification.

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: 20-012840
NCT ID:
NCT03433274
Sponsor Protocol Number:
CS0004-P

A Study to Evaluate a Computerized Stethoscope called ©CompuSteth to Diagnose Heart Disease

Rochester, MN

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A Study to Evaluate a Computerized Stethoscope called ©CompuSteth to Diagnose Heart Disease

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 identify patients presenting to the echocardiogram laboratroy for routine clinically indicated echocardiography or to the cardiac catheterization laboratory for routine clinically indicated catheterization procedures. These patients will undergo a cardiac physical examination using the ( VoqX) stethoscope for the following 2 aims:

1) Collect computerized auscultation data to train the ©VoqX device on how a variety of cardiac pathologies "sound", including normal heart sounds, aortic stenosis, and mitral valve disease, after identifying these cardiac pathologies using gold-standard testing with echocardiography or invasive cardiac catheterization.

2)Prospectively determine the accuracy of the ©VoqX device as a tool to non-invasively screen for structural cardiac pathologies, by comparing the results in terms of structural cardiac pathologies ascertained from using the ©VoqX device with those derived from echocardiography or cardiac catheterization testing.

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: 20-012844
NCT ID:
NCT04960280

A Study to Evaluate Mitral Implantation of Transcatheter Valves

Rochester, MN

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A Study to Evaluate Mitral Implantation of Transcatheter Valves

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.
Study phase:
2/3
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to enroll high surgical risk patients with severe mitral annular calcification (MAC) and symptomatic mitral valve disease. There are 2 arms in this study: Transseptal Valve-in-MAC (ViMAC) and a control arm of patients treated with medical treatment only which will include patients who can't be treated due to the presence of anatomical exclusion criteria or other exclusion criteria.

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: 20-010096
NCT ID:
NCT04408430
Sponsor Protocol Number:
20-010096

TVMR With the Innovalve System Trial - Early Feasibility Study

Rochester, MN

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TVMR With the Innovalve System Trial - Early Feasibility Study

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.
Study phase:
1
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

About this study

The purpose of this study is to assess the technical and procedural success of the Innovalve TMVR system when used to treat adult patients with symptomatic moderate-severe and severe mitral regurgitation who are at elevated risk for surgical mitral valve repair or replacement and who are anatomically eligible for a transfemoral catheterization with transseptal approach to the left atrium.

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

Print study details

Site IRB:
- Rochester, Minnesota: 21-004739
NCT ID:
NCT04919980
Sponsor Protocol Number:
DMS-9144

A Study to Evaluate Long-term Outcomes of Alcohol Septal Ablation for Hypertrophic Cardiomyopathy

Rochester, MN

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A Study to Evaluate Long-term Outcomes of Alcohol Septal Ablation for Hypertrophic Cardiomyopathy

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 determine long term vital status, symptoms, and need for repeat procedure after alcohol septal ablation, to determine patient and procedural factors associated with successful alcohol septal ablation and need for repeat procedure, and to determine the impact of conduction abnormalities after alcohol septal ablation on long-term outcomes.

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

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Site IRB:
- Rochester, Minnesota: 19-008770
Sponsor Protocol Number:
19-008770

Surgical Outcomes of Mitral Valve Repair

Rochester, MN

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Surgical Outcomes of Mitral Valve 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 learn more about early and late outcomes in patients after mitral valve repair.

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: 17-010238
Sponsor Protocol Number:
17-010238

A Study to Identify the Genetic Defect(s) in Individuals with Arrhythmogenic Bi-Leaflet Mitral Prolapse (aBiMVP)

Rochester, MN

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A Study to Identify the Genetic Defect(s) in Individuals with Arrhythmogenic Bi-Leaflet Mitral Prolapse (aBiMVP)

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 elucidate the genetic basis of aBiMVP in hopes of determining novel mechanisms that underlie aBiMVP pathogenesis.

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

Print study details

Site IRB:
- Rochester, Minnesota: 17-002065
Sponsor Protocol Number:
17-002065

Stress Echo 2030

Rochester, MN

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Stress Echo 2030

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

This study (SE2030) will establish a platform of data to build the perfect stress echo test, suitable for all patients, anywhere, anytime, also quantitative and operator independent.

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

Print study details

Site IRB:
- Rochester, Minnesota: 21-006982

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Search Results 1-10 of 11 for

A Study to Assess the Feasibility of Combining Clinically- indicated MitraClip Transcatheter Mitral Valve Repair (TMVR) and Watchman Left Atrial Appendage Occlusion (LAAO)

The ENCIRCLE Trial

Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation

A Study to Evaluate a Computerized Stethoscope called ©CompuSteth to Diagnose Heart Disease

A Study to Evaluate Mitral Implantation of Transcatheter Valves

TVMR With the Innovalve System Trial - Early Feasibility Study

A Study to Evaluate Long-term Outcomes of Alcohol Septal Ablation for Hypertrophic Cardiomyopathy

Surgical Outcomes of Mitral Valve Repair

A Study to Identify the Genetic Defect(s) in Individuals with Arrhythmogenic Bi-Leaflet Mitral Prolapse (aBiMVP)

Stress Echo 2030

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