DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation

NCT03643224 | Completed Results DMC FDA Device

• 1 other identifier: TP01071
• Study Type: interventional
• Target: 376
• Locations: 6 countries
• Sites: 28

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.

Conditions

Persistent Atrial Fibrillation; Atrial Fibrillation

Keywords

ablation; electrophysiology; atrial fibrillation; catheter; persistent

Outcome Measures

Primary Outcomes (2)

• Primary Safety Events

  Participant count of a composite of safety events including: serious adverse events (SAEs), procedure and/or device-related significant pericardial effusion, severe or clinically symptomatic pulmonary vein stenosis and atrioesophageal fistula

  Ablation through 6 months

• Primary Effectiveness

  The primary effectiveness endpoint is defined as freedom from documented AF, Atrial Flutter, (AFL) and Atrial Tachycardia (AT) episodes following the blanking period (3-month follow-up post-ablation procedure) through the end of the effectiveness evaluation period (12-month follow-up post-ablation procedure).

  12 months

Secondary Outcomes (13)

• Freedom From a Composite of Serious Adverse Events (SAEs)

  Within 30-days post-index ablation

• Freedom From Documented AF/AFL/AT Episodes

  Within 3 months

• Freedom From Documented AF/AFL/AT Episodes in the Absence of Class I and III Anti-arrhythmic Drug Therapy.

  Within 3 months

• Acute Procedural Success

  Day of index ablation procedure

• Single Procedure Success With Freedom From AF/AT/AFL

  12 months after the index ablation procedure

Other Outcomes (7)

• Total Procedure Time (Minutes)

  Immediately after the index ablation procedure

• Total Treatment Device Time (Minutes)

  Day of index ablation procedure

• Cumulative RF Time

  Day of index ablation procedure

Study Arms (1)

Experimental

EXPERIMENTAL

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

Device: Radiofrequency Ablation

Interventions

Radiofrequency Ablation DEVICE

A procedure will be performed using a radiofrequency ablation catheter.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Above eighteen (18) years of age or of legal age to give informed consent specific to state and national law.
• 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.
• Refractory, intolerant or contraindicated to at least one Class I or III anti-arrhythmic (AAD) drug.
• Suitable candidate for intra-cardiac mapping and ablation of arrhythmia.
• Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months after enrollment.
• Subject is willing and able to provide written consent.

You may not qualify if:

• At time of enrollment and/or prior to procedure:
• Continuous AF \>12 months (long-standing persistent AF)
• Paroxysmal AF with longest episode \<7 days
• AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause
• Rheumatic heart disease
• Severe mitral regurgitation
• Hypertrophic cardiomyopathy
• LA diameter \>5.5 cm
• Left ventricular ejection fraction (LVEF) \<40%
• Currently NYHA Class III or IV or exhibits uncontrolled heart failure
• Body Mass Index (BMI) \>42 kg/m2.
• LA ablation, septal closure device or mitral valve surgical procedure at any time prior to enrollment
• Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation
• Coagulopathy, bleeding diathesis or suspected procoagulant state
• Sepsis, active systemic infection or fever (\>100.5 oF / 38 oC) within a week prior to the ablation procedure

Sponsors & Collaborators

• Medtronic Cardiac Ablation Solutions: lead

Study Sites (28)

Grandview Medical Center

Birmingham, Alabama, 35242, United States

Location

University Of Alabama

Birmingham, Alabama, 35294, United States

Location

Keck School Of Medicine

Los Angeles, California, 90033, United States

Location

Advent Health, Florida Hospital Orlando

Orlando, Florida, 32751, United States

Location

Iowa Heart Center

West Des Moines, Iowa, 50266, United States

Location

Kansas City Heart Rhythm Institute

Overland Park, Kansas, 66211, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

Location

North Mississippi Medical Center

Tupelo, Mississippi, 38801, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Montefiore Medical Center

New York, New York, 10467, United States

Location

Trident Medical Center

Charleston, South Carolina, 29406, United States

Location

Medical University Of South Carolina

Charleston, South Carolina, 29425, United States

Location

Texas Cardiac Arrhythmia Research Foundation

Austin, Texas, 78705, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Southlake Regional Health Center

Newmarket, Ontario, L3Y2P6, Canada

Location

Montreal Heart Institute

Montreal, Quebec, HITC8, Canada

Location

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

Québec, Quebec, G1V4G5, Canada

Location

Institut Klinicke a Experimentalni Mediciny (IKEM)

Prague, Czechia, 14021, Czechia

Location

Na Homolce

Prague, Prague, 15000, Czechia

Location

St Ann's University Hospital

Brno, 65691, Czechia

Location

Clinique du Tonkin

Villeurbanne, Lyon, 69100, France

Location

CHRU Nancy

Nancy, 54511, France

Location

Clinique Saint Pierre

Perpignan, 66000, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Leipzig Heart Institute GmbH

Leipzig, 04289, Germany

Location

Centro Cardiologico Monzino

Milan, Milano, 20138, Italy

Location

Ospedale dell'Angelo

Venezia, 30174, Italy

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Results Point of Contact

• Title: Josman Suri
• Organization: Medtronic CAS

josman.suri@medtronic.com

7635050262

Study Officials

• Atul Verma, MD

  Medical Director, Heart Rhythm Program, Southlake Regional Health Centre

  PRINCIPAL INVESTIGATOR

• Andrea Natale, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 22, 2018
• Study Start: September 19, 2018
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: October 23, 2025
• Results First Posted: October 23, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (3); US (15); DE (1); FR (4); IT (2); CA (3)