This is the second of three case studies covered in a webinar Castor held with AKRN Scientific Consulting. Watch the webinar for more insights from the AKRN team. You can also download this case study below.
Pulmonary vein isolation (PVI) is a procedure that can block irregular electrical signals in patients with atrial fibrillation (AF) and other heart conditions, and make that patient’s heart beat normally. However, there are significant limitations to measuring the success of this treatment and optimizing how effective it is. This is largely due to the fact that there are many diverse PVI methodologies returning disparate and inconclusive data. According to the limited study data available, success rates for PVI after 3-5 years sit at only 30-50%.1
To combat the ambiguity of PVI, a digital health company, Company Y, developed a solution that’s revolutionizing the way that we measure this data and determine how effective the procedure is. With their innovative AI algorithm, Company Y can measure the success rate of PVI, begin making improvements to this largely unreliable procedure, and start improving long- term quality of life for patients with chronic heart conditions.
Although, proving the effectiveness of this AI algorithm would be challenging — Company Y needed to collect and standardize complex PVI data across four sites, with limited time to visit each site. It was essential for their team to have a straightforward, yet comprehensive eCRF form to collect the data they need in this short amount of time.
Capturing complex, unstructured data
With the support of their partners AKRN Scientific Consulting, a medical device CRO based in Europe, Company Y would be equipped with the infrastructure and expertise needed to solve this data capture challenge and prove the efficacy of their tech in a clinical setting. A study of 100 participants, separated into four sites in Belgium and France, would determine whether their AI algorithm was an effective tool for monitoring patients’ PVI procedures.
Researchers from AKRN and Company Y faced the challenge of capturing complex PVI data in a standardized format. Even with modern advancements, it remains complicated to capture every detail you might need in a traditional clinical trial case report form (CRF) and gain regulatory approval from investigators.
At the sites, clinicians didn’t have the time to fill out long forms with multiple dependencies, as it was impractical in the limited time during site visits. They needed an electronic CRF simple enough that clinicians could easily understand and enter data to hold all the PVI analyzer results, yet comprehensive enough to capture all data fields needed for regulatory approval, including:
- Date & time of index procedures
- Types of procedure
- Heart isolations
- Heart pacing
- Subject monitoring
Streamlining case report form (CRF) entry
AKRN’s team of clinical trial experts chose Castor EDC for a simplified, standardized way to collect PVI data and measure success rates. Partnered with Castor, AKRN would be equipped with an eCRF that was easy to use, efficient, and effective; enabling providers to quickly and systematically capture data at each site. Some of the benefits from using Castor’s eCRF included:
- Self-service form building
- Multiple options for restricting data entry options
- Easily readable text fields for clinicians entering data
“They decided they wanted to have just a simple eCRF—with a simple feature that was easy to use. It had a quick overview of what was happening and the status of everything and just a repository instead of having a lengthy eCRF that doubles the information they already have.”
– Iñigo Marquet De Solís, Clinical Research Scientist & Data Manager, AKRN By Namsa
Striving for better PVI success rates
AKRN and Company Y were able to complete their 100-person study in nine months to help test the effectiveness of their PVI analyzer in confirming PVI results. Collecting study data with Castor’s eCRF was easy for clinicians— reducing the burden of conducting this study in a fast-paced environment and expediting a process that would normally be lengthy and cumbersome. As a result, Company Y and AKRN are on the path to finally deliver an accurate, standardized, and seamless way to measure the long-term effectiveness of the PVI procedure, and provide the data needed to prompt a push for better PVI success rates.
- “Is pulmonary vein isolation still the cornerstone in atrial fibrillation ….” https://www.ncbi.nlm.nih.gov/pmc/ articles/PMC4321067/. Accessed 30 Aug. 2022.