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Enabling Safe Cardiac Procedures: A Space Maker Device Clinical Trial

A pioneering cardiovascular device company developed a Class III implantable cardiac space maker-designed to temporarily create pericardial space during minimally invasive structural heart procedures. As a high-risk implantable device, the product required rigorous clinical investigation under FDA IDE and EU MDR for CE Marking.

Client Challenges

  • Conduct a first-in-human (FIH) and pivotal trial across multiple global cardiac centers
  • Demonstrate safety, biocompatibility, and functional performance during and after pericardial access
  • Navigate complex FDA IDE submission, DSMB oversight, and EU MDR Annex XIV compliance
  • Coordinate logistics, training, and data flow for live surgical environments
  • Prepare for event-driven analysis, including device-related SAE tracking

Clinvigilant Research Solution

Clinical Strategy & Regulatory Pathway

  • Designed and submitted a detailed Clinical Investigation Plan (CIP), including:
  • Primary endpoint: Device deployment success without cardiac injury
  • Secondary endpoints: Surgeon usability, operative time, pericardial clearance, recovery metrics
  • Led the FDA IDE preparation, including pre-sub (Q-sub) meetings and biocompatibility justifications
  • Supported EU MDR pathway with generation of:
  • Clinical Evaluation Plan (CEP)
  • Risk-Benefit Analysis
  • PMCF strategy

Intraoperative Data Capture & Imaging Integration

  • Developed a real-time eSource workflow integrated with:
  • Intraoperative transesophageal echo (TEE) imaging logs
  • Device deployment video documentation
  • Operating room nurse-reported usability assessments
  • Captured data on:
  • Deployment duration
  • Inflation parameters
  • Device retrieval success
  • Pericardial injury (if any)

Site Enablement & Surgeon Training

  • Activated 6 cardiac surgery centers in U.S. and EU
  • Organized live and virtual proctoring sessions with KOLs
  • Delivered surgical playbooks, animation-based training, and validated operative checklist CRFs

Safety Oversight & Risk Mitigation

  • Established a DSMB with cardiac surgery experts
  • Defined SAE reporting timelines and causality adjudication
  • Conducted real-time safety reviews using Clinvigilant’s event tracking dashboard
  • Engaged a third-party imaging core lab to validate pericardial access images

Data Management & Regulatory Reporting

  • Locked database 45 days post last-patient-follow-up
  • Delivered
  • Clinical Study Report (CSR) for FDA PMA module
  • Clinical Evaluation Report (CER) + GSPR checklist for EU
  • Supported Notified Body Q&A and FDA pre-PMA panel prep

Outcomes

45

Total Subjects
(FIH + Pivotal)

100%

Deployment
Success Rate

4.9 / 5.0

Surgeon Satisfaction
(5-point Likert)

1

(resolved without intervention)

Device-related
Adverse Events

7 weeks from submission

IDE Approval Timeline

Delivered within 10 weeks of DB lock

PMA Submission

Accepted with no major comments

EU CER Review Outcome

Client Testimonial

Chief Medical Officer
Cardiac Device Company

“Clinvigilant was instrumental in helping us navigate the high-risk device space. Their clinical team, data quality standards, and ability to support both FDA and EU MDR requirements gave us speed and confidence.”

Value Delivered

Clinvigilant Research successfully executed a complex, multicenter clinical investigation for a Class III cardiac device, combining real-time surgical data capture, risk oversight, and regulatory expertise-positioning the sponsor for FDA PMA submission and EU market entry with confidence.

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