---
title: CONFORM TRIAL PORTAL
---

[![CONFORM pivotal trial negative_blue RGB](https://info.conformalmedical.com/hs-fs/hubfs/CONFORM%20pivotal%20trial%20negative_blue%20RGB.png?width=200&height=78&name=CONFORM%20pivotal%20trial%20negative_blue%20RGB.png "CONFORM pivotal trial negative_blue RGB")](https://info.conformalmedical.com/conform-trial-portal?hsLang=en)

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# Site Startup Documents

CONFORM IDE Trial NCT05147792

## Welcome New Sites Participating in the CONFORM IDE Trial

Use the links below to download documents from the CONFORM Trial startup binder.  

![Screenshot 2025-02-25 at 10.11.18 AM](https://info.conformalmedical.com/hubfs/Screenshot%202025-02-25%20at%2010.11.18%20AM.png)

## Protocols & ICF Documents

### Protocol Rev. R

18Feb2026

[ Download Here

](https://info.conformalmedical.com/hubfs/(C-5)%20CONFORM%20Protocol%20Rev%20R%20Clean.pdf?hsLang=en)

### Protocol Synopsis Rev. R

18Feb2026

[ Download Here

](https://info.conformalmedical.com/hubfs/(C-13)%20CONFORM%20Protocol%20Rev%20R%20Synopsis.pdf?hsLang=en)

### CONFORM Pivotal TEE Imaging Acquisition Protocol

V. 6.0 12Mar2024

[ Download Here

](https://info.conformalmedical.com/hubfs/CONFORM%20Pivotal%20Trial_DAF_TEE%20Imaging%20Aquisition%20Protocol_V6.0_12Mar2024_Signed.pdf?hsLang=en)

### CONFORM Angio Protocol

V1.0 13Apr2023

[ Download Here

](https://info.conformalmedical.com/hubfs/CONFORM%20Angio%20Protocol%20V1.0.pdf?hsLang=en)

### CONFORMAL CT Acquisition Protocol Rev. A

 15Jun2022

[ Download Here

](https://info.conformalmedical.com/hubfs/CONFORMAL%20CT_Acquisition%20Protocol_Rev%20A_Executed_15Jun2022-1.pdf?hsLang=en)

### CONFORM Template ICF Rev. R

27March2026

[ Download Here

](https://info.conformalmedical.com/hubfs/CONFORM%20Template%20Consent%20Form%20Rev%20R.doc?hsLang=en)

## Budget & CTA Documents

### CONFORM Pivotal Payment Terms Template

V. 6.1 Mar25

[ Download Here

](https://info.conformalmedical.com/hubfs/CONFORM%20Pivotal%20Payment%20Terms%20Template%20V6.1.docx?hsLang=en)

### CONFORM Pivotal Trial Detailed Budget Rev. K

V9.1 Mar25

[ Download Here

](https://info.conformalmedical.com/hubfs/CONFORM%20Pivotal%20Trial%20Detailed%20Budget%20Rev%20K%20V9.1.xlsx?hsLang=en)

### CONFORM Investigator Agreement (US)

 V. 2.0 Mar2025

[ Download Here

](https://info.conformalmedical.com/hubfs/CONFORM_Investigator%20Agreement%20(US)_Template_V2.0-3.docx?hsLang=en)

### Conformal - Pivotal Clinical Trial Agreement Template

V. 8.0 6Mar2024

[ Download Here

](https://info.conformalmedical.com/hubfs/Conformal%20-%20Pivotal%20Clinical%20Trial%20Agreement%20Template%20V8.0%2006MAR24.docx?hsLang=en)

### Conformal Medical CONFORM IDE Reimbursement Guide

V. 1.0 15Jul2022

[ Download Here

](https://info.conformalmedical.com/hubfs/Conformal%20Medical%20CONFORM%20IDE%20Reimbursement%20Guide%20(v1.0)-3.pdf?hsLang=en)

### Conformal Medical CONFORM IDE study - Sample Prior Authorization Letter

V. 1.0 Mar2025

[ Download Here

](https://info.conformalmedical.com/hubfs/Conformal%20Medical%20CONFORM%20IDE%20study%20-%20Sample%20Prior%20Authorization%20Letter%20V1.0-2.docx?hsLang=en)

### F-90 Financial Disclosure Form Rev. B

Mar2025

[ Download Here

](https://info.conformalmedical.com/hubfs/F-90%20Financial%20Disclosure%20Form%20Rev%20B%20Clean-1.pdf?hsLang=en)

### W9 Conformal Medical

Mar2025

[ Download Here

](https://info.conformalmedical.com/hubfs/W9%20Conformal%20Medical%20-%20signed%203-15-24-1.pdf?hsLang=en)

### Subject Injury Language Support

CED Approval CONFORMAL Pivotal Trial letter

23Mar2022

[ Download Here

](https://info.conformalmedical.com/hubfs/CED%20Approval%20CONFORMAL%20Pivotal%20Trial%20letter%2023-Mar-2022%5B3%5D.pdf?hsLang=en)

### Subject Injury Language Support

Medicare National Coverage Determination

07Sept2007

[ Download Here

](https://info.conformalmedical.com/hubfs/Medicare%20National%20Coverage%20Determination%20dated%20September%207%2c%202007.pdf?hsLang=en)

### Subject Injury Language Support

Subject Injury Language Rationale

23Mar2022

[ Download Here

](https://info.conformalmedical.com/hubfs/Subject%20injury%20language%20rationale.pdf?hsLang=en)

### CMS—No Cost Device Amount to Place on Claim

MLN909368 May2022

[ Download Here

](https://info.conformalmedical.com/hubfs/No%20Cost%20Device%20Amount%20to%20place%20on%20claim-1.pdf?hsLang=en)

## FDA & CMS Approval Documents

### CED Approval CONFORM IDE Trial Letter

 23Mar2022

[ Download Here

](https://info.conformalmedical.com/hubfs/CED%20Approval%20CONFORMAL%20Pivotal%20Trial%20letter%2023-Mar-2022-4.pdf?hsLang=en)

### FDA Approval, Supplement 016/A001

22Dec2021

[ Download Here

](https://info.conformalmedical.com/hubfs/G180189-S016.Letter.APCN.APPR-3.pdf?hsLang=en)

### FDA Approval, Supplement 033

13Dec2023

[ Download Here

](https://info.conformalmedical.com/hubfs/G180189_S033%20CONFORM%20Pivotal%2013DEC2023-2.pdf?hsLang=en)

### FDA Approval Letter to Resume CONFORM IDE Trial

20Dec2024

[ Download Here

](https://info.conformalmedical.com/hubfs/G180189-S041_Approved-Re-start_20Dec2024.pdf?hsLang=en)

## Instructions for Use Documents

### CLAAS System IFU Rev. L

12May2025

[ Download Here

](https://info.conformalmedical.com/hubfs/60-00430_CLAAS%20System%20IFU_Rev%20L-1.pdf?hsLang=en)

## Patient Facing Materials

 Please make sure your IRB has approved the use of these materials. 

### CLAAS Device for Demonstration

[ Download Here

](https://info.conformalmedical.com/hubfs/CLAAS%20Device%20for%20Demonstration-2.pdf?hsLang=en)

### CONFORMAL Clinical Trial Poster Rev. C

[ Download Here

](https://info.conformalmedical.com/hubfs/CONFORMAL%20Clinical%20Trial%20Poster_Proof_Rev.%20C-1.pdf?hsLang=en)

### Conformal Medical Implant Card Rev. B

[ Download Here

](https://info.conformalmedical.com/hubfs/Conformal%20Medical%20Implant%20Card%2060-00432%20Rev.%20B_clean.pdf?hsLang=en)

### Conformal Medical Patient Brochure Rev. C

[ Download Here

](https://info.conformalmedical.com/hubfs/Conformal%20Medical%20Patient%20Brochure_Proof_%20Rev.%20C.pdf?hsLang=en)

### Conformal Medical Patient Magnet Rev. A

[ Download Here

](https://info.conformalmedical.com/hubfs/Conformal%20Medical%20Patient%20Magnet%20(60-00445%20Rev%20A).pdf?hsLang=en)

### Implant Flipbook Conform Pivotal

[ Download Here

](https://info.conformalmedical.com/hubfs/Implant%20Flipbook%20Conform%20Pivotal.pdf?hsLang=en)

## CONFORM Trial Referral Letters & Form

Conformal has crafted a referral letter and form to help** Trial Investigators **inform **referring cardiologists and fellow physicians** that your hospital/center is enrolling patients the CONFORM Pivotal Trial. 

This letter serves as a professional introduction to the study, outline its purpose and patient eligibility, and encourage collaboration in identifying potential participants. Providing clear, consistent information ensures referring physicians are aware of the clinical trial. 

### NEW CONFORM SITES — CONFORM Trial Referral Letter V.1

 For new sites who have recently joined the study. 

[ Download Here

](https://info.conformalmedical.com/hubfs/MC-64_v1.0_CONFORM%20Trial%20Referral%20Letter_New-Sites%20(3).docx?hsLang=en)

### CURRENT SITES— CONFORM Trial Referral Letter V1.

 Recommended for CONFORM Sites who have been with the study for more than 9 months.

[ Download Here

](https://info.conformalmedical.com/hubfs/MC-64_v1.0_CONFORM%20Trial%20Referral%20Letter_Current-Sites%20(2).docx?hsLang=en)

### CONFORM Trial Referral Form V1.

 Share this form with your referral partners as a way to access which of your non-valvular atrial fibrillation (AFib) patients may be appropriate for a Left Atrial Appendage Occlusion (LAA) device and connect them with an implanter for a consultation about treatment options including the CLAAS AcuFORM LAAO device

[ Download Here

](https://info.conformalmedical.com/hubfs/MC-107_CONFORM-Pivotal-Trial_Referral%20Form_digital%20(1).pdf?hsLang=en)

## CONFORM IDE Trial Regulatory Binder

Use the link below to download the full CONFORM Trial Regulatory binder. 

13Apr2026

[ Download Here

](https://info.conformalmedical.com/hubfs/CONFORM%20Reg%20Binder%20Merge%20Updated%2013Apr2026.pdf?hsLang=en)

![Regulatory Binder](https://info.conformalmedical.com/hubfs/Regulatory%20Binder.png)

CAUTION: Investigational Device   
Limited by federal (or United States) law to investigational use. Outside the United States, the device is intended exclusively for clinical investigation. Not approved for commercial use.