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Presentation TCT 2025

Regulatory Approvals for Therapies for Patients with “Not Suitable for Conventional Therapy?"

Presenter: Jeffrey Popma

October 28, 2025

Presentation TCT 2025

How Does Real World Evidence Fit into the Regulatory Pathway?

Presenter: David J. Cohen

October 28, 2025

Presentation TCT 2025

Heterotopic Valves

Presenter: Rishi Puri

October 28, 2025

Presentation TCT 2025

TTVR

Presenter: Kashish Goel

October 28, 2025

Presentation TCT 2025

Novel Structural Therapies for Pulmonary Hypertension: Balancing Safety, Functional Improvements, and Clinical Efficacy

Presenter: Daniel Burkhoff

October 28, 2025

Presentation TCT 2025

Regulatory Controversies for Transcatheter Mitral Therapies: Are There Options Beyond the Red Zone?

Presenter: Jeffrey Popma

October 28, 2025

Presentation TCT 2025

Long Long-Term Follow-up

Presenter: Sreekanth Vemulapalli

October 28, 2025

Presentation TCT 2025

Breakthrough Device Designation: Current Insights

Presenter: Todd J. Brinton

October 28, 2025

Presentation TCT 2025

EFS in the US is Back! What’s needed for EFS 2.0 to Maintain and Grow the Program?

Presenter: Michael J. Mack

October 28, 2025

Presentation TCT 2025

Clinical Evidence Experience with First Human Use

Presenter: Alexandre Abizaid

October 28, 2025

Presentation TCT 2025

Expanding Labelling Indications: RCT, Well Constructed Registries, or Both

Presenter: Brad Sutton

October 28, 2025

Presentation TCT 2025

Same Setting Hybrid Procedures: Pulse Field Ablation and Left Atrial Appendage Closure

Presenter: Shephal K. Doshi

October 28, 2025

Presentation TCT 2025

Evidence Requirements for New Generation LAAC

Presenter: Jason H. Rogers

October 28, 2025

Presentation TCT 2025

European Transition from Medical Device Director (MDD) to Medical Device Regulation (MDR): Roadmap for the Future of Global AF Studies

Presenter: Philippe PM Garot

October 28, 2025

Presentation TCT 2025

How Data from the AHA and C3TN Registries of Cardiogenic Shock can Improve Care of Patients with Cardiogenic Shock

Presenter: David A. Morrow

October 28, 2025

Presentation TCT 2025

Evaluating Best Practice Adherence and Outcomes in Cardiogenic Shock: The OASIS Study

Presenter: Navin K. Kapur

October 28, 2025

Presentation TCT 2025

Can New Devices be Approved from Single Arm Studies: Use of Real-World Data as an External Control Group or for Propensity Matching or Generating Objective Performance Criteria

Presenter: Daniel Burkhoff

October 28, 2025

Presentation TCT 2025

Is There a Practical Solution for Emergency Consent in USA Shock RCTs?

Presenter: Graham Nichol

October 28, 2025

Presentation TCT 2025

Moving to Randomized SCAI A Shock CAD Phenotype Approval Studies: Barriers & Solutions

Presenter: Mitchell W. Krucoff

October 28, 2025

Presentation TCT 2025

Electrosurgical Tools in Structural Heart Interventions: How to Drive Best Practices, Device Development, and Regulatory Approval

Presenter: Adam B. Greenbaum

October 28, 2025

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Regulatory Approvals for Therapies for Patients with “Not Suitable for Conventional Therapy?"

How Does Real World Evidence Fit into the Regulatory Pathway?

Heterotopic Valves

TTVR

Novel Structural Therapies for Pulmonary Hypertension: Balancing Safety, Functional Improvements, and Clinical Efficacy

Regulatory Controversies for Transcatheter Mitral Therapies: Are There Options Beyond the Red Zone?

Long Long-Term Follow-up

Breakthrough Device Designation: Current Insights

EFS in the US is Back! What’s needed for EFS 2.0 to Maintain and Grow the Program?

Clinical Evidence Experience with First Human Use

Expanding Labelling Indications: RCT, Well Constructed Registries, or Both

Same Setting Hybrid Procedures: Pulse Field Ablation and Left Atrial Appendage Closure

Evidence Requirements for New Generation LAAC

European Transition from Medical Device Director (MDD) to Medical Device Regulation (MDR): Roadmap for the Future of Global AF Studies

How Data from the AHA and C3TN Registries of Cardiogenic Shock can Improve Care of Patients with Cardiogenic Shock

Evaluating Best Practice Adherence and Outcomes in Cardiogenic Shock: The OASIS Study

Can New Devices be Approved from Single Arm Studies: Use of Real-World Data as an External Control Group or for Propensity Matching or Generating Objective Performance Criteria

Is There a Practical Solution for Emergency Consent in USA Shock RCTs?

Moving to Randomized SCAI A Shock CAD Phenotype Approval Studies: Barriers & Solutions

Electrosurgical Tools in Structural Heart Interventions: How to Drive Best Practices, Device Development, and Regulatory Approval

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