DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation

NCT ID: NCT03643224

Last Updated: 2025-10-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 376 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-19
• Study Completion Date: 2024-10-31

Brief Summary

The purpose of the Diamond-AF II study is to establish the safety and effectiveness of the DiamondTemp Ablation System for the treatment of drug refractory, symptomatic persistent atrial fibrillation in patients.

Detailed Description

The DIAMOND-AF II Study is a prospective, non-randomized (single-group assignment) trial being performed at multiple centers in the United States, Canada and Europe to evaluate the safety and effectiveness of the DiamondTemp Ablation System for the treatment of patients with persistent atrial fibrillation.

Conditions

Persistent Atrial Fibrillation; Atrial Fibrillation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

Radiofrequency Ablation. Catheter ablation to treat persistent atrial fibrillation using temperature-controlled ablation catheter

Group Type: EXPERIMENTAL

Radiofrequency Ablation

Intervention Type: DEVICE

A procedure will be performed using a radiofrequency ablation catheter.

Interventions

Radiofrequency Ablation

A procedure will be performed using a radiofrequency ablation catheter.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.

2. Subjects with a history of documented symptomatic, persistent Atrial Fibrillation with 1) a physician's note documenting a continuous AF episode lasting longer than 7 days but less than 12 months AND 2) two electrocardiograms from any form of rhythm monitoring showing continuous AF taken at least 7 days apart OR a 24-hour Holter within 180 days of the ablation procedure showing continuous AF.

3. Refractory, intolerant or contraindicated to at least one Class I or III anti-arrhythmic (AAD) drug.

4. Suitable candidate for intra-cardiac mapping and ablation of arrhythmia.

5. Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months after enrollment.

6. Subject is willing and able to provide written consent.

Exclusion Criteria

At time of enrollment and/or prior to procedure:

1. Continuous AF >12 months (long-standing persistent AF)

2. Paroxysmal AF with longest episode <7 days

3. AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause

4. Rheumatic heart disease

5. Severe mitral regurgitation

6. Hypertrophic cardiomyopathy

7. LA diameter >5.5 cm

8. Left ventricular ejection fraction (LVEF) <40%

9. Currently NYHA Class III or IV or exhibits uncontrolled heart failure

10. Body Mass Index (BMI) >42 kg/m2.

11. LA ablation, septal closure device or mitral valve surgical procedure at any time prior to enrollment

12. Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation

13. Coagulopathy, bleeding diathesis or suspected procoagulant state

14. Sepsis, active systemic infection or fever (>100.5 oF / 38 oC) within a week prior to the ablation procedure

15. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition

16. Renal failure requiring dialysis or renal compromise that in the investigator's judgement would increase risk to the subject or deem the subject inappropriate to participate in the study.

17. Known allergies or intolerance to anticoagulant and antiplatelet therapies to be used in conjunction with the study or contrast sensitivity that cannot be adequately pre-treated prior to the ablation procedure.

18. Positive pregnancy test results for female subjects of childbearing potential or breast feeding.

19. Enrollment in a concurrent clinical study that in the judgement of the investigator would impact study outcomes.

20. Acute or chronic medical condition that in the judgment of the investigator would increase risk to the subject or deem the subject inappropriate to participate in the study.

21. Life expectancy <12 months based on medical history or the medical judgement of the investigator.

Within 1 month of enrollment or just prior to procedure:

22. Documented LA thrombus upon imaging

23. Creatinine >2.5mg/dl or creatinine clearance <30mL/min

Within 3 months of enrollment:

24. Significant gastrointestinal (GI) bleed

25. Myocardial infarction (MI), unstable angina, cardiac surgery or coronary intervention

Within 6 months of enrollment:

26. Coronary artery bypass graft (CABG) procedure

27. Implant procedure performed for ICD, CRT leads or pacemaker

28. Documented stroke, CVA, TIA or suspected neurological event

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Ablation Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Atul Verma, MD

Role: PRINCIPAL_INVESTIGATOR

Medical Director, Heart Rhythm Program, Southlake Regional Health Centre

Andrea Natale, MD

Role: PRINCIPAL_INVESTIGATOR

Director, Electrophysiology, Texas Cardiac Arrhythmia Institute at St. David's Medical Center

Locations

Grandview Medical Center

Birmingham, Alabama, United States

University Of Alabama

Birmingham, Alabama, United States

Keck School Of Medicine

Los Angeles, California, United States

Advent Health, Florida Hospital Orlando

Orlando, Florida, United States

Iowa Heart Center

West Des Moines, Iowa, United States

Kansas City Heart Rhythm Institute

Overland Park, Kansas, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Jackson Heart Clinic

Jackson, Mississippi, United States

North Mississippi Medical Center

Tupelo, Mississippi, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Montefiore Medical Center

New York, New York, United States

Trident Medical Center

Charleston, South Carolina, United States

Medical University Of South Carolina

Charleston, South Carolina, United States

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, United States

Houston Methodist Hospital

Houston, Texas, United States

Southlake Regional Health Center

Newmarket, Ontario, Canada

Montreal Heart Institute

Montreal, Quebec, Canada

Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)

Québec, Quebec, Canada

Institut Klinicke a Experimentalni Mediciny (IKEM)

Prague, Czechia, Czechia

Na Homolce

Prague, Prague, Czechia

St Ann's University Hospital

Brno, , Czechia

Clinique du Tonkin

Villeurbanne, Lyon, France

CHRU Nancy

Nancy, , France

Clinique Saint Pierre

Perpignan, , France

Clinique Pasteur

Toulouse, , France

Leipzig Heart Institute GmbH

Leipzig, , Germany

Centro Cardiologico Monzino

Milan, Milano, Italy

Ospedale dell'Angelo

Venezia, , Italy

Countries

United States; Canada; Czechia; France; Germany; Italy

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

TP01071

Identifier Type: -

Identifier Source: org_study_id