Medtronic Terminate AF Study

Part of paid clinical trials in Palo Alto, California.

Sponsor
Medtronic Cardiac Surgery
Study ID
NCT03546374
Status
Recruiting
Apply to this trial

Conditions

  • Longstanding Persistent Atrial Fibrillation
  • Persistent Atrial Fibrillation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Surgical Ablation — PROCEDURE
    In addition to the concomitant surgery, subjects are required to have amputation or closure (with sutures or ligation) of the left atrial appendage.The Cox Maze IV lesion set is required to be performed.
  • Cardioblate and Cryoflex hand held devices — DEVICE
    The Cardioblate hand held devices consist of the Cardioblate iRF and Cryoflex surgical ablation devices.

Study Details

The purpose of this study is to demonstrate the safety and effectiveness of the Cardioblate iRF and CryoFlex hand held devices for the treatment of non-paroxysmal atrial fibrillation (AF).

Key Dates

Start date
Nov 15, 2018
Status verified
May 2026
Primary completion
Oct 1, 2024
Completion
Dec 31, 2026

Study Design

Enrollment
160 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Primary Cohort
    Patients with a history of persistent atrial fibrillation and long-standing persistent atrial fibrillation (non-paroxysmal atrial fibrillation) who are undergoing concomitant cardiac surgery

Primary Outcome Measure

Composite acute major adverse event rate [ Time Frame: 30-days post-procedure or hospital discharge (whichever is longer) ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Stanford Hospitals and ClinicPalo AltoCalifornia94304-
Adventist Health St. HelenaSt. HelenaCalifornia94574-
Hartford HealthcareHartfordConnecticut06102-
St Vincent Heart Center of IndianaIndianapolisIndiana46290
David Heimansohn, MD
[email protected]
Massachusetts General HospitalBostonMassachusetts02114
Serguei Melnitchouk, MD
[email protected]
Corewell HealthGrand RapidsMichigan49503
Edward Murphy, MD
[email protected]
Washington University School of MedicineSt LouisMissouri63110
Ralph J Damiano, MD
[email protected]
ProMedica ToledoToledoOhio43606-
Allegheny General HospitalPittsburghPennsylvania15212
Stephen Bailey, MD
[email protected]
Lankenau Medical CenterWynnewoodPennsylvania19096-
Intermountain Medical CenterMurrayUtah84107-
Sentara Norfolk General HospitalNorfolkVirginia23507-
Swedish Medical CenterSeattleWashington98122
Eric Lehr, MD
[email protected]
Virginia Mason Heart InstituteSeattleWashington98101
Robert Moraca, MD
[email protected]
St. Joseph Medical CenterTacomaWashington98405-

Find similar trials in Palo Alto, CA

By research site
Stanford Hospitals and Clinic· Palo Alto, CAAdventist Health St. Helena· St. Helena, CAHartford Healthcare· Hartford, CTSt Vincent Heart Center of Indiana· Indianapolis, INMassachusetts General Hospital· Boston, MACorewell Health· Grand Rapids, MI

Related Studies