One participation package
Registry participation, the MANIFEST-ASC study schedule, and the Business Associate Agreement (BAA), with California and Texas addenda where applicable.
An ACCESS Foundation program
ACCESS Registry · Enrollment now open
ACCESS Registry & MANIFEST-ASC Study
Help build the evidence for catheter ablation in ambulatory surgery centers. Join a multicenter observational registry sponsored by ACCESS Foundation, a 501(c)(3) nonprofit. Participation is free: your site pays no participation fee and receives no payment.
What you’re signing
One agreement. A clear role for your center.
No participation fee or payment
Your site pays nothing and receives no payment for participation. ACCESS covers the platform and data management; ACCESS Foundation covers the central IRB.
Your routine care, your records
Your staff enter standard-of-care catheter ablation cases. No study-mandated procedures, extra visits, or ACCESS/Sponsor chart monitoring.
No enrollment target
Activation follows signing and delivery of the required IRB/reliance materials and public registration record. Eligible earlier cases may be entered as permitted by the protocol and waivers.
Your center’s numbers stay protected
Site-level operational data are not disclosed to third parties without your prior written consent for each disclosure, subject to required legal disclosures.
Central IRB oversight
The v7 agreement identifies Advarra central IRB approval with waivers of informed consent and HIPAA authorization. Your site remains responsible for any local review its own policies require.
This is a summary of the unsigned v7 agreement, not a replacement for it. Review the complete terms before signing.
Study & governance
MANIFEST-ASC: catheter ablation in the ASC
MANIFEST-ASC is a prospective, multicenter observational registry evaluating the safety, efficacy, and efficiency of standard-of-care catheter ablation performed in ambulatory surgery centers. The current participation agreement covers catheter ablation.
Network principal investigators: Arash Aryana, MD, PhD; Vijay Swarup, MD; and Vivek Reddy, MD. Investigator interests are disclosed in the protocol and managed through the IRB process.
ACCESS Foundation — nonprofit sponsor
ACCESS Foundation, a 501(c)(3) nonprofit, holds the research grants, pays the central IRB, owns the study database and de-identified data, and governs publications.
ACCESS — platform and data operations
ACCESS hosts the Registry and holds identifiable data as your site’s HIPAA business associate under the BAA. Your site retains ownership of its medical records and protected health information.
Independent of device selection
The agreement identifies research grants from Medtronic and Biosense Webster. Funders have no role in clinical care or device selection, no platform access, and receive aggregate de-identified data only.
The agreement requires public study registration before enrollment. Ask registry@accesspartner.org for the public registration record and your site’s IRB/reliance materials.
Your team’s workflow
Direct entry or worksheet upload. Your choice.
Record standard-of-care cases
Enter the defined case information directly in the Registry web app, or upload the approved one-page ACCESS worksheet at your site’s election.
Verify every extracted field
Your site staff confirm each worksheet transcription. Unverified transcriptions remain quarantined and are never exported. The agreement provides for worksheet image deletion after verification or within 30 days, whichever is earlier.
Follow up from your own records
Enter 30- and 90-day outcomes from records in your site’s custody, including ordinary post-procedure contacts. ACCESS does not contact patients for study follow-up.
Review quality together
Electronic edit checks, queries, and aggregate data-quality reports support completeness. Neither ACCESS nor the Sponsor performs source-data verification or accesses your medical charts; regulatory and IRB inspection rights still apply.
Your data
Defined access. Clear ownership.
Identifiable data stay within the protected Registry environment. ACCESS de-identifies data under the BAA before analytic use. The Foundation does not receive patient-identifiable information.
Funders receive aggregate de-identified information only. Named, authorized Foundation analysts and permitted licensee personnel may access restricted de-identified records under the agreement’s safeguards. They do not receive the keys that identify sites or patients.
Your center’s reports are for your center. ACCESS may provide your site with its own data and benchmarking against de-identified aggregates. Your site-level numbers are not shared with device companies, other centers, or the Sponsor without your prior written consent for each disclosure, subject to required legal disclosures.
The Foundation may license de-identified data under the agreement’s restrictions. Review Sections 8–9 and Exhibit A for access, permitted uses, retention, publication, and licensing terms.
Participation boundaries
What this Registry is not
Not a device-company registry
ACCESS Foundation sponsors the study. Funders receive aggregate de-identified data only and have no access to the Registry platform.
Not a change to patient care
No study-mandated procedures, investigational products, or extra visits. Clinical decisions remain with your physicians.
Not a purchasing commitment
Participation is separate from GPO enrollment, purchasing, management services, and other commercial arrangements. There is no payment tied to enrollment, volume, or device choice.
Not a public patient-data submission form
Use DocuSign for center participation details. Enter clinical data only through the approved Registry workflow after site activation.
Enroll now
Review. Sign. Prepare your team.
Open the DocuSign form, review the agreement, and complete your site’s information and signature. The signing sequence is your site, ACCESS, then ACCESS Foundation; the agreement’s Effective Date is the final Foundation signature.
Activation also requires delivery of the IRB approval and reliance acceptance, and public study registration. Under the agreement, ACCESS provisions user accounts and provides training within five business days after execution. No enrollment target or separate activation deadline applies.
Enroll your center now in DocuSign ↗Before you enroll
Questions from administrators and investigators
Do we need our own IRB?
The v7 agreement identifies Advarra central IRB approval and waivers of informed consent and HIPAA authorization. Sites rely on the central IRB unless their policies prohibit it, and remain responsible for any required local review. Obtain the approval letter and reliance acceptance before activation.
Who sees our center’s numbers?
Your site receives its own reports. ACCESS uses site-level information internally to operate the Registry and conduct quality review. Disclosure of site-level operational data to third parties requires your prior written consent for each disclosure, subject to required legal disclosures. Funders receive aggregates only; designated Foundation analysts and permitted licensees may access restricted de-identified records under Sections 8–9.
What about California and Texas law?
Exhibits B and C are included in the agreement and apply automatically to sites performing study procedures in California or Texas. They address state-specific privacy and related obligations. Additional state terms are added when required before patient data are entered.
What does participation cost?
There is no participation fee and no payment to your site or investigators. ACCESS pays platform and data-management costs; the Foundation pays central IRB fees. Your staff perform the data-entry and follow-up responsibilities described in the agreement.
When can we start, and can we enter earlier cases?
Activation follows execution of the Schedule and BAA, delivery of the central IRB approval letter and reliance acceptance, and public study registration. ACCESS provides accounts and training within five business days after execution. Earlier eligible cases may be entered from your records to the extent the IRB-approved protocol and waivers permit. There is no enrollment target.
Do we have to upload worksheets or arrange extra patient visits?
No. Your staff may enter data directly or choose the approved worksheet-upload workflow and verify every transcription. Follow-up at 30 and 90 days comes from your own records and ordinary clinical contacts. There are no study-mandated procedures or extra visits.
Who owns the data, and can we withdraw?
Your site retains its medical records and protected health information. The Foundation owns the study database and de-identified data and may license them under the agreement’s restrictions. Study withdrawal requires 30 days’ notice; agreement termination requires 60 days’ notice. Data already contributed remain in the Registry. Review the agreement for retention and publication terms.
Does this enroll us in GPO or cover CIED procedures?
No. GPO participation has a separate agreement. This Registry participation package includes MANIFEST-ASC and covers catheter ablation. It does not add a CIED study module or automatically grant member portal access.
These answers summarize the agreement; the signed document governs. Review the complete terms in DocuSign before signing.
Join the ACCESS Registry
Review the participation agreement and enroll your center online. Questions? Email registry@accesspartner.org or call (833) 742-2237.
Enroll your center now