Informed Consent for Participation in an Advanced Cardiology Research Study

Procedure Name

Form Sections

Section 1info grid

Research Institution / Clinic

Principal Investigator

Participant Full Legal Name

Date of Birth

Full Study Protocol Title

NCT Protocol Number

IRB Approval Number

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Section 9signature block

Participant Signature

Investigator or Person Obtaining Consent Signature

Independent Witness Signature

Date and Time of Consent

Informed Consent for Participation in an Advanced Cardiology Research Study

Study and Participant Information

Research Institution / Clinic

Principal Investigator

Participant Full Legal Name

Date of Birth

Full Study Protocol Title

NCT Protocol Number

IRB Approval Number

Purpose and Background of the Research

You are being invited to participate in a clinical research study. Before you decide to participate, FDA regulations (21 CFR Part 50) and international guidelines require that you fully understand the experimental nature of this study, its potential risks, and what will be expected of you. The primary purpose of this clinical trial is to evaluate the safety, efficacy, and clinical performance of an experimental cardiac device or protocol (such as a next-generation percutaneous heart valve or drug-eluting scaffold). Standard cardiac interventions have limitations, and this research aims to generate scientific evidence comparing this new approach against established standards of care. Approximately [X] participants will enroll across multiple medical centers.

Description of Study Procedures

Screening and Baseline Testing: Detailed clinical evaluation, echocardiogram, computed tomography (CT) scan, and blood draws to confirm eligibility.

Randomized Treatment Intervention: 1:1 computer-based assignment to either the experimental device group or the active standard control group.

Longitudinal Follow-up: Regular clinic visits at 1, 3, 6, and 12 months, followed by annual phone calls or checkups for up to 5 years.

Biobanking and Secondary Research: Storage of leftover blood or tissue specimens for future unspecified genomic or cardiovascular research.

Material Risks and Potential Complications

Significant risk of myocardial infarction (heart attack) during the percutaneous valve insertion or catheter manipulation.

Acute renal failure (kidney failure) following iodinated contrast medium administration, which may require temporary or permanent dialysis.

Risks of sudden cardiac death associated with the experimental device insertion, severe arrhythmias, or vascular dissection.

Vascular access complications including retroperitoneal bleeding, pseudoaneurysm, or occlusion at the insertion site.

Privacy risk: potential for data exposure or re-identification of de-identified genomic profiles.

Reasonable Alternatives to Participation

Standard clinical care: undergoing standard FDA-approved valve replacement or coronary stenting outside of a clinical trial.

Optimal medical therapy using pharmacological agents (beta-blockers, nitrates, statins) without invasive intervention.

Participating in a different cardiology clinical trial or registry.

Decline participation and undergo no active clinical intervention.

Data Privacy and HIPAA Protections

Your identity and protected health information will be shielded. Coded identifiers will replace your direct identification markers on all research databases. Authorized representatives from the Study Sponsor, the Food and Drug Administration (FDA), and the Institutional Review Board (IRB) may inspect study records to ensure scientific integrity. Data shared with collaborating researchers will be fully de-identified. The Genetic Information Nondiscrimination Act (GINA) protects you from genetic-based discrimination by health insurers or employers.

Voluntary Participation and Right to Withdraw

Your participation in this trial is entirely voluntary. You may choose to withdraw from the study at any time without penalty or loss of benefits. If you withdraw, no new data will be collected, but data collected prior to your withdrawal will remain part of the trial database to preserve the validity of the scientific findings as mandated by FDA regulations.

Specimen Storage for Future Research (Optional)

[ ] I agree to have my de-identified biological samples (blood, tissue, DNA) stored in the study biobank for future approved research studies related to cardiovascular disease.

[ ] I do NOT agree to biospecimen storage for future research; my samples will be analyzed for this study only and destroyed thereafter.

Signatures and Verification

Participant Signature

Investigator or Person Obtaining Consent Signature

Independent Witness Signature

Date and Time of Consent

Document ID: CC-PENDING

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