DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation (Diamond-AFII)

October 7, 2025 updated by: Medtronic Cardiac Ablation Solutions

A Prospective Clinical Evaluation of the DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
376

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Newmarket, Ontario, Canada, L3Y2P6
        • Southlake Regional Health Center
    • Quebec
      • Montreal, Quebec, Canada, HITC8
        • Montreal Heart Institute
      • Québec, Quebec, Canada, G1V4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
  • Czechia
      • Brno, Czechia, 65691
        • St Ann's University Hospital
    • Czechia
      • Prague, Czechia, Czechia, 14021
        • Institut klinicke a experimentalni mediciny (IKEM)
    • Prague
      • Prague, Prague, Czechia, 15000
        • Na Homolce
  • France
      • Nancy, France, 54511
        • CHRU Nancy
      • Perpignan, France, 66000
        • Clinique Saint Pierre
      • Toulouse, France, 31076
        • Clinique Pasteur
    • Lyon
      • Villeurbanne, Lyon, France, 69100
        • Clinique du Tonkin
  • Germany
      • Leipzig, Germany, 04289
        • Leipzig Heart Institute GmbH
  • Italy
      • Venezia, Italy, 30174
        • Ospedale dell'Angelo
    • Milano
      • Milan, Milano, Italy, 20138
        • Centro Cardiologico Monzino
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama
      • Birmingham, Alabama, United States, 35242
        • Grandview Medical Center
    • California
      • Los Angeles, California, United States, 90033
        • Keck School of Medicine
    • Florida
      • Orlando, Florida, United States, 32751
        • Advent Health, Florida Hospital Orlando
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Iowa Heart Center
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Kansas City Heart Rhythm Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Jackson Heart Clinic
      • Tupelo, Mississippi, United States, 38801
        • North Mississippi Medical Center
    • New York
      • New York, New York, United States, 10029
        • Icahn School of Medicine at Mount Sinai
      • New York, New York, United States, 10467
        • Montefiore Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Charleston, South Carolina, United States, 29406
        • Trident Medical Center
    • Texas
      • Austin, Texas, United States, 78705
        • Texas Cardiac Arrhythmia Research Foundation
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental
Radiofrequency Ablation. Catheter ablation to treat persistent atrial fibrillation using temperature-controlled ablation catheter
Device: Radiofrequency Ablation
A procedure will be performed using a radiofrequency ablation catheter.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Primary Safety Events
Time Frame: Ablation through 6 months
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
Time Frame: 12 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Freedom From a Composite of Serious Adverse Events (SAEs)
Time Frame: Within 30-days post-index ablation
Freedom from a composite of SAEs occurring within 30-days post-index ablation procedure as adjudicated by an independent CEC for relatedness to the procedure or device.
Within 30-days post-index ablation
Freedom From Documented AF/AFL/AT Episodes
Time Frame: Within 3 months
Freedom from documented AF/AFL/AT episodes during the effectiveness evaluation period lasting ≥ 30 seconds in duration by ECG monitoring.
Within 3 months
Freedom From Documented AF/AFL/AT Episodes in the Absence of Class I and III Anti-arrhythmic Drug Therapy.
Time Frame: Within 3 months
Freedom from documented AF/AFL/AT episodes during the effectiveness evaluation period in the absence of class I and III anti-arrhythmic drug therapy.
Within 3 months
Acute Procedural Success
Time Frame: Day of index ablation procedure
Participant count of acute procedural success, defined as confirmation of electrical isolation of PVs via assessment of entrance block at least 20 minutes following the last ablation around the respective PV
Day of index ablation procedure
Single Procedure Success With Freedom From AF/AT/AFL
Time Frame: 12 months after the index ablation procedure
Participant count of single procedure success defined as the rate of subjects treated with one single ablation procedure for the entire enrollment period and with freedom from documented symptomatic AF, AT and AFL* at 12 months.
12 months after the index ablation procedure
Single Procedure Success With Freedom From All Primary Effectiveness Failures
Time Frame: 12 months
Participant count of single procedure success with freedom from all primary effectiveness failure criteria.
12 months
AFEQT Quality of Life, Baseline
Time Frame: Day of index ablation procedure

QOL using the AFEQT Questionnaire, baseline questionnaires.

The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100.
Day of index ablation procedure
AFEQT Quality of Life, 6-month Follow-up
Time Frame: 6 months after index ablation procedure

QOL using the AFEQT Questionnaire, 6 month questionnaires.

The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100.
6 months after index ablation procedure
AFEQT Quality of Life, 12-month Follow up
Time Frame: 12 months after index ablation procedure

QOL using the AFEQT Questionnaire, 12-month questionnaires.

The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100.
12 months after index ablation procedure
Change in AFEQT Quality of Life From Baseline to 12-month
Time Frame: Index ablation procedure through 12 months

Changes in QOL using the AFEQT Questionnaire between 12-month and baseline questionnaires.

The scale is the AF Effect on Quality-of-Life (AFEQT) score. Higher scores are better. Minimum value: 0. Maximum value: 100.
Index ablation procedure through 12 months
National Institutes of Health Stroke Scale, Pre-discharge
Time Frame: Day of index ablation procedure

Neurological changes measured using the National Institutes of Health Stroke Scale (NIHSS)

The NIHSS which is comprised of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score possible is 0.
Day of index ablation procedure
National Institutes of Health Stroke Scale, One- Month Follow up
Time Frame: One month after index ablation procedure

Neurological changes measured using the National Institutes of Health Stroke Scale (NIHSS)

The NIHSS which is comprised of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score possible is 0.
One month after index ablation procedure
National Institutes of Health Stroke Scale, 12-month Follow-up
Time Frame: 12 months after the index ablation procedure

Neurological changes measured using the National Institutes of Health Stroke Scale (NIHSS)

The NIHSS which is comprised of 11 items, each of which scores a specific ability between a 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed in order to calculate a patient's total NIHSS score. The maximum possible score is 42, with the minimum score possible is 0.
12 months after the index ablation procedure

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Total Procedure Time (Minutes)
Time Frame: Immediately after the index ablation procedure
Total procedure time (minutes), defined as time of investigational catheter insertion into the vasculature to time of last procedural ablation catheter removed.
Immediately after the index ablation procedure
Total Treatment Device Time (Minutes)
Time Frame: Day of index ablation procedure
Total treatment device time (minutes), defined as time of delivery of first RF ablation with investigational catheter to removal of the investigational catheter.
Day of index ablation procedure
Cumulative RF Time
Time Frame: Day of index ablation procedure
Mean cumulative RF Time (minutes).
Day of index ablation procedure
Duration of RF Ablations (Seconds)
Time Frame: Day of index ablation procedure
Mean duration of RF ablations (seconds)
Day of index ablation procedure
Fluid Infused Through the Investigational Catheter (mL)
Time Frame: Day of index ablation procedure
Total fluid infused through the investigational catheter (mL)
Day of index ablation procedure
Fluoroscopy Time (Minutes)
Time Frame: Day of index ablation procedure
Total fluoroscopy exposure time (minutes)
Day of index ablation procedure
Incidence of Re-hospitalizations Due to Atrial Fibrillation Recurrence.
Time Frame: Between 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).
Number of subjects who were re-hospitalized due to atrial fibrillation recurrence after blanking period.
Between 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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Cardiac Ablation Solutions

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 19, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 21, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 22, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 23, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TP01071

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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