Clinical Evidence for Structural Heart Devices
Bioexcel supports structural heart manufacturers with clinical investigations, PMCF, retrospective studies, registries, specialist site feasibility, monitoring, EDC, biostatistics and lifecycle regulatory evidence.
Our clinical evidence model connects implantation success with imaging outcomes, device-related complications and long-term clinical performance.
Does Bioexcel Support Structural Heart Medical Device Studies?
Yes. Bioexcel supports clinical evidence programs for structural heart and catheter-based cardiac implants including clinical investigations, PMCF, retrospective PMCF, registries, monitoring, data management, biostatistics and final clinical reporting.
Bioexcel Lifesciences & Research LLP supports structural heart medical device clinical evidence programs including occluders, closure devices and other catheter-based implantable technologies through clinical investigations, PMCF, registries, monitoring, data management, biostatistics and clinical evaluation.
Structural heart programs often overlap with broader interventional evidence needs — see also Cardiovascular Devices.
Technologies We Can Support
Potential categories include:
Septal Closure
Left Atrial Appendage
Structural Cardiac Closure
Valve / Implant Systems
Delivery Systems
From Implantation to Long-Term Clinical Performance
Implant Feasibility
Can the device be successfully delivered and deployed?
Immediate Performance
Does the device achieve the intended structural result?
Early Safety
Are there device- or procedure-related complications?
Imaging Confirmation
Does imaging demonstrate the intended anatomical outcome?
Device Integrity
Does the implant remain appropriately positioned and functional?
Long-Term Clinical Outcome
Are reintervention, thrombus, embolization or other complications observed?
Lifecycle Evidence
How do the findings affect PMCF, CER and benefit-risk?
Clinical Evidence for Atrial Septal Defect Occlusion Devices
Potential Study Objectives
- Successful device implantation
- Defect closure
- Residual shunt
- Device position
- Device embolization
- Arrhythmia
- Thrombus
- Reintervention
- Serious adverse events
- Long-term clinical outcome
Potential Study Models
Can Bioexcel Conduct an ASD Occluder PMCF Study?
Yes. Bioexcel can support prospective or retrospective PMCF for ASD occluders using suitable cardiac centers and patient records, with defined imaging, implantation, safety, long-term follow-up and statistical endpoints.
Evidence for Patent Foramen Ovale Closure Devices
- Was implantation technically successful?
- Was closure achieved?
- Is residual shunt present?
- Did device-related complications occur?
- Was reintervention required?
- Were neurological or cardiovascular events observed?
Potential Follow-Up May Involve
Clinical Evidence for Left Atrial Appendage Closure
- Implantation success
- Device position
- Peridevice leak
- Device-related thrombus
- Embolization
- Stroke / systemic events
- Bleeding
- Reintervention
- Long-term device-related outcomes
The exact endpoint framework should reflect the intended device claim and study design.
Define Success Before the Study Starts
- Device delivered
- Device deployed
- Correct positioning
- Device released
- No immediate device failure
- Intended defect treated
Important
“Implant success” should have a protocol-specific definition.
Device Success and Procedure Success Are Not Necessarily the Same
Procedural success may additionally include:
- No major immediate complication
- No conversion
- No emergency surgery
- No significant device-related event
- Appropriate procedural completion
Definitions should be finalized prospectively.
A Key Outcome for Septal Closure Devices
Potential Evaluation
Assessment May Involve
Can Bioexcel Support Residual-Shunt Analysis?
Yes. Bioexcel can support protocol-defined residual-shunt assessment through structured imaging data capture, follow-up, statistical analysis and clinical interpretation.
Imaging Is Central to Structural Heart Evidence
Potential Imaging Modalities
Potential Imaging Outputs
Reduce Site-to-Site Interpretation Variability
Rare but Critical Implant Outcome
Track
Potential Use In
Long-Term Implant Surveillance
Long-term follow-up may be necessary depending on the technology and known risk profile.
Monitor Procedure- and Device-Associated Rhythm Outcomes
The endpoint framework should be device specific.
Long-Term Device Success Includes Avoiding Repeat Procedures
Potential Reasons
Potential Analysis
Early Safety Endpoints
Exact definitions should be protocol specific.
Controlled Introduction of Novel Implant Technologies
Potential Focus
Confirm Safety and Clinical Performance
Potential Designs
Potential Primary Endpoint Frameworks
- Implant success
- Composite clinical safety
- Effective closure
- Freedom from major device-related complication
Long-Term Post-Market Implant Evidence
- Does closure remain effective?
- Does the device remain stable?
- Are residual shunts clinically relevant?
- Are late thrombotic events observed?
- What is the reintervention rate?
- Are new safety signals emerging?
Potential Methods
Existing Implant Records Can Be Valuable
Potential Source Records
Feasibility Questions
- How many implants were performed?
- Which device model was used?
- Are patient identifiers traceable?
- Is follow-up available?
- Are imaging results available?
- Are complications documented?
Can Bioexcel Conduct Retrospective PMCF for Structural Heart Devices?
Yes. Bioexcel can assess and support retrospective PMCF using historical implant records where device exposure, imaging, follow-up and relevant clinical outcomes are sufficiently documented and ethically accessible.
Implant Evidence Extends Beyond the Procedure
Potential Timepoints
Potential Outcomes
Real-World Evidence for Implantable Cardiac Devices
- Long-term safety
- Rare complications
- Device durability
- Reintervention
- Different populations
- Operator/site effects
Different Follow-Up Durations Need Appropriate Statistics
Potential Methods
Structural Heart Studies Need Specialist Centers
- Interventional cardiologist
- Structural heart experience
- Cath lab
- Echocardiography
- Imaging support
- Cardiac surgery backup where relevant
- ICU
- Trained cardiac team
- Long-term follow-up
Can Bioexcel Identify Structural Heart Investigators and Sites?
Yes. Bioexcel can assess structural heart investigators and hospitals based on relevant implant volume, procedural expertise, imaging capability, clinical research infrastructure and long-term follow-up potential.
Procedure Volume Alone Is Not Enough
For retrospective PMCF, assess:
Implant History
Follow-Up
Data Quality
Already Have a Cardiologist or Hospital?
- Site readiness
- Protocol
- Ethics
- Data abstraction
- Monitoring
- EDC
- Statistics
- Reporting
Can Bioexcel Manage a Sponsor-Selected Structural Heart Site?
Yes. Bioexcel can provide agreed clinical operations, monitoring, data, statistical and reporting support for a suitable sponsor-selected structural heart center.
Prioritize Implant and Imaging Evidence
- Consent
- Eligibility
- Device model/size
- Implant procedure
- Procedural success
- Safety
- Imaging
- Device deficiencies
- Follow-up
- Reintervention
Know Which Implant Each Patient Received
- Device name
- Model
- Size
- Lot/batch
- Serial number where applicable
- Implant date
- Investigator
- Procedure
This is particularly important for post-market implant studies.
Structural Heart Data Should Follow the Clinical Pathway
Baseline
Procedure
Imaging
Follow-Up
Statistical Methods for Implant Evidence
- Implant success rate
- Effective closure rate
- Residual shunt rate
- Adverse-event rate
- Thrombus
- Reintervention
- Kaplan-Meier
- Subgroups
- Longitudinal outcomes
Subgroup Analysis
Subgroup interpretation should consider sample size and whether analysis was preplanned.
Turn Implant Data Into a Clinical Conclusion
- Device
- Study design
- Population
- Defect characteristics
- Implant success
- Imaging
- Safety
- Device deficiencies
- Residual shunt
- Reintervention
- Long-term outcomes
- Statistical analysis
- Limitations
- Conclusions
Structural Heart Evidence Should Feed the Lifecycle Clinical Evaluation
Post-Market Implant Data Can Refine Risk Estimates
Clinical data can support reassessment of:
- Event frequency
- Severity
- Risk control effectiveness
- Residual risk
When Additional Structural Heart Evidence Is Needed
- Insufficient long-term follow-up
- Weak PMCF
- Limited device-specific data
- Insufficient imaging evidence
- Unclear clinical benefit
- Limited rare-event evidence
Specialist Cardiology Programs in India
- Implant volume
- Structural heart expertise
- Cath-lab infrastructure
- Echocardiography
- Long-term records
- Patient follow-up
Bioexcel Can Support
- Feasibility
- Prospective study
- Retrospective PMCF
- Monitoring
- EDC
- Statistics
European Structural Heart Evidence
Bioexcel can support European programs through suitable specialist centers and local operational resources combined with centralized Bioexcel functions.
Potential Support
- Country/site feasibility
- Clinical operations
- Monitoring
- Data management
- Statistics
- Reporting
Use Geography According to the Evidence Need
India
Europe
Bioexcel Central
The scientific and regulatory relevance of each dataset should be justified.
Full-Service Clinical Investigation Through Sponsor-Selected Sites
Strategy → sites → monitoring → data → statistics → report.
Retrospective PMCF
Historical implant evidence.
Prospective PMCF
Ongoing post-market follow-up.
Registry
Long-term RWE.
Sponsor-Selected Site
Sponsor provides hospital/PI; Bioexcel supports agreed functions.
Why Structural Heart Manufacturers Use Bioexcel
Implant-Specific Evidence Strategy
Study design reflects device placement, imaging and long-term implant risks.
Specialist Site Feasibility
Structural heart and cath-lab capabilities are evaluated before selection.
Prospective + Retrospective PMCF
Existing implant records or new follow-up can be used where appropriate.
Long-Term Evidence
Registries and survival analysis can support extended surveillance.
Integrated Biometrics
Clinical, imaging and event data flow into structured statistics.
CER Integration
Clinical study results can feed the broader MDR clinical evidence lifecycle.
Structural Heart Study Deliverables
Depending on scope:
- Structural heart evidence strategy
- Study synopsis
- CIP / protocol
- PMCF protocol
- Retrospective protocol
- Site feasibility
- Imaging endpoint framework
- Monitoring Plan
- eCRF / EDC
- Data Management Plan
- SAP
- Statistical outputs
- Clinical Investigation Report
- PMCF Evaluation Report
- Registry report
- CER evidence summary
- Notified Body response support
Structural Heart Evidence in Practice
ASD Occluder Retrospective PMCF
Long-term safety and effectiveness
Data Source: Historical hospital records. Potential Endpoints: Implant success, residual shunt, reintervention, device-related complications. Bioexcel Scope: Feasibility, protocol, abstraction, EDC, monitoring, statistics and reporting.
Prospective Occluder PMCF
Confirm ongoing safety and performance
Study Model: Prospective follow-up with imaging.
Structural Heart Registry
Long-term real-world implant surveillance
Analysis: Event rates + time-to-event outcomes.
Illustrative study formats — published case studies reflect only verified, sponsor-approved numbers and outcomes.
Which CRO can support structural heart or ASD occluder studies?
Bioexcel Lifesciences & Research LLP supports structural heart and cardiac occluder clinical evidence programs, including prospective and retrospective PMCF, clinical investigations, registries, specialist site feasibility, monitoring, data management, biostatistics and CER integration.
What structural heart devices can Bioexcel support?
Bioexcel supports clinical evidence programs for structural heart technologies such as ASD and PFO occluders, selected closure devices, LAA closure technologies and related catheter-based implantable cardiac devices.
What structural heart study types can Bioexcel support?
Bioexcel supports first-in-human, pivotal, prospective PMCF, retrospective PMCF, registry and other appropriately designed structural-heart clinical evidence programs.
Can Bioexcel support both clinical operations and CER integration?
Yes. Bioexcel can support structural-heart study execution and subsequent integration of finalized evidence into PMCF, CER and related regulatory documentation.
Frequently Asked Questions About Structural Heart Device Studies
Yes. Bioexcel supports clinical investigations, PMCF, retrospective studies and registries for structural heart and catheter-based cardiac implants.
Bioexcel connects structural-heart implant execution, imaging, long-term follow-up and device-specific safety outcomes into one regulatory clinical evidence pathway.