COMPANY

CardioFocus

HQ: Marlborough, MA source · cardiofocus.com ↗ · New England

FDA-cleared device company Past trials only

Location: Marlborough, MA · source · Oct 14, 2026

Profile checked Oct 10, 2026

Keywords: Atrial Fibrillation Paroxysmal Atrial Fibrillation Atrial Fibrillation (Paroxysmal) Persistant Atrial Fibrillation breast cancer pulsed field ablation HeartLight X3 HeartLight EAS-AC (HeartLight) CardioFocus EAS-AC CardioFocus HeartLight Endoscopic Ablation System Endoscopically Guided Ablation

11Trials (company is sponsor)10NIH grants

Timeline

Dec 12, 2024 Trial start Not phased (device or behavioral study): Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF source ↗
Feb 27, 2023 Trial start Not phased (device or behavioral study): Ablation With the PFA System With a Large-Area Focal Catheter for the Treatment of Persistent Atrial Fibrillation source ↗
Feb 26, 2019 Trial start Not phased (device or behavioral study): HeartLight X3 Endoscopic Ablation System With Excalibur Balloon for Treatment of Symptomatic Persistent AF source ↗
Feb 15, 2018 Trial start Not phased (device or behavioral study): Clinical Study of the HeartLight X3 Endoscopic Ablation System With Excalibur Balloon source ↗
Jun 16, 2017 Trial start Not phased (device or behavioral study): CardioFocus HeartLight Post-Approval Study source ↗
2012-01 Trial start Phase 3: HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF) source ↗
2010-09 Trial start Phase 4: Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation source ↗
2009-12 Trial start Phase 4: Post-Market Randomized Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation source ↗
2009-09 Trial start Phase 2: Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation source ↗
2009-08 Trial start Phase 3: Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic AF source ↗
2007-03 Trial start Phase 3: Pivotal Clinical Study of Endoscopic Ablation for Atrial Fibrillation (AF) in Patients That Have Failed Drugs source ↗

Upcoming milestones

2026-10 (ESTIMATED) · Not phased · CardioFocus HeartLight Post-Approval Study · NCT03168659
Mar 31, 2027 (ESTIMATED) · Not phased · Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF · NCT06828939

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 11

Record	Title	Phase	Status	Start	Primary completion
NCT06828939	Pulmonary Vein Isolation With the Single Shot Endoscopic Ultra-Compliant PFA Balloon for the Treatment of AF	Not phased (device or behavioral study)	Recruiting	Dec 12, 2024	Mar 31, 2027 (estimated)
NCT07281521	Ablation With the PFA System With a Large-Area Focal Catheter for the Treatment of Persistent Atrial Fibrillation	Not phased (device or behavioral study)	Active, not recruiting	Feb 27, 2023	2026-08 (estimated)
NCT03168659	CardioFocus HeartLight Post-Approval Study	Not phased (device or behavioral study)	Recruiting	Jun 16, 2017	2026-10 (estimated)
NCT03988244	HeartLight X3 Endoscopic Ablation System With Excalibur Balloon for Treatment of Symptomatic Persistent AF	Not phased (device or behavioral study)	Completed	Feb 26, 2019	Apr 30, 2019 (actual)
NCT03470636	Clinical Study of the HeartLight X3 Endoscopic Ablation System With Excalibur Balloon	Not phased (device or behavioral study)	Completed	Feb 15, 2018	Nov 15, 2018 (actual)
NCT01456000	HeartLight Ablation in Patients With Paroxysmal Atrial Fibrillation (PAF)	Phase 3	Completed	2012-01	2014-12 (actual)
NCT00958165	Clinical Study of the CardioFocus Endoscopic Ablation System for the Treatment of Symptomatic AF	Phase 3	Completed	2009-08	2012-03 (actual)
NCT00971204	Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation	Phase 2	Completed	2009-09	2011-12 (actual)
NCT01057394	Post-Market Randomized Trial: Endoscopically- Guided Ablation vs. Radiofrequency Ablation	Phase 4	Terminated	2009-12	2011-06 (actual)
NCT01196923	Post-Market Clinical Study of the CardioFocus Endoscopic Ablation System - Adaptive Contact (CF-EAS-AC) for the Treatment of Symptomatic Atrial Fibrillation	Phase 4	Completed	2010-09	2012-03 (actual)
NCT00477230	Pivotal Clinical Study of Endoscopic Ablation for Atrial Fibrillation (AF) in Patients That Have Failed Drugs	Phase 3	Terminated	2007-03	2009-05 (actual)

NIH awards 10

Annual award amounts. Total $2.1M.

Jul 30, 1999 NIH award 1R43HL063536-01 FY1999: $99,909 awarded for that fiscal year; activity R43 (SBIR); PI SINOFSKY, EDWARD L; recipient as written: CARDIOFOCUS, INC., MARLBOROUGH, MA. PHOTONIC TREATMENT OF ATRIAL ARRHYTHMIA source ↗
Jun 18, 1998 NIH award 1R43CA074675-01A1 FY1998: $99,517 awarded for that fiscal year; activity R43 (SBIR); PI SINOFSKY, EDWARD L; recipient as written: CARDIOFOCUS, INC., MARLBOROUGH, MA. X RAY GUIDED LASER THERAPY SYSTEM FOR BR source ↗
Apr 20, 1998 NIH award 5R44HL054397-03 FY1998: $367,940 awarded for that fiscal year; activity R44 (SBIR); PI SINOFSKY, EDWARD L; recipient as written: CARDIOFOCUS, INC., MARLBOROUGH, MA. CATHETER FOR SIMULATANEOUS MAPPING AND LA source ↗
Feb 27, 1997 NIH award 2R44HL054397-02 FY1997: $380,475 awarded for that fiscal year; activity R44 (SBIR); PI SINOFSKY, EDWARD L; recipient as written: CARDIOFOCUS, INC., MARLBOROUGH, MA. CATHETER FOR SIMULATANEOUS MAPPING AND LA source ↗
Jun 7, 1996 NIH award 1R43HD034314-01 FY1996: $99,991 awarded for that fiscal year; activity R43 (SBIR); PI SINOFSKY, EDWARD L; recipient as written: CARDIOFOCUS, INC., MARLBOROUGH, MA. TRANSCERVICAL STERILIZATION USING LASER DI source ↗
Jun 7, 1996 NIH award 1R43CA069870-01 FY1996: $100,000 awarded for that fiscal year; activity R43 (SBIR); PI SINOFSKY, EDWARD L; recipient as written: CARDIOFOCUS, INC., MARLBOROUGH, MA. CONTROLLING THERMAL LESION VOLUME WITH AN source ↗
Apr 5, 1996 NIH award 5R44CA060225-03 FY1996: $360,012 awarded for that fiscal year; activity R44 (SBIR); PI SINOFSKY, EDWARD L; recipient as written: CARDIOFOCUS, INC., MARLBOROUGH, MA. DIFFUSING TIPS FOR LASER THERAPY source ↗
Sep 1, 1995 NIH award 1R43HL054397-01 FY1995: $99,978 awarded for that fiscal year; activity R43 (SBIR); PI SINOFSKY, EDWARD L; recipient as written: CARDIOFOCUS, INC., MARLBOROUGH, MA. CATHETER FOR SIMULTANEOUS MAPPING AND LASE source ↗
Mar 21, 1995 NIH award 2R44CA060225-02 FY1995: $388,684 awarded for that fiscal year; activity R44 (SBIR); PI SINOFSKY, EDWARD L; recipient as written: CARDIOFOCUS, INC., MARLBOROUGH, MA. DIFFUSING TIPS FOR LASER THERAPY source ↗
Jan 21, 1994 NIH award 1R43CA060225-01A1 FY1994: $74,488 awarded for that fiscal year; activity R43 (SBIR); PI SINOFSKY, EDWARD L; recipient as written: CARDIOFOCUS, INC., MARLBOROUGH, MA. DIRECTIONAL & ISOTROPIC DIFFUSING TIPS F source ↗