Persistent Atrial FibrillationDiamond-AFIINCT03643224
DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation
A study testing Radiofrequency Ablation in people with Persistent Atrial Fibrillation and Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 28 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Atrial Fibrillation, Atrial Fibrillation
- What is being tested?
- Radiofrequency Ablation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 28 sitesin 6 countries
- Study dates
- 19 Sep 2018to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 32Show fewer
- 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
- Significant restrictive or obstructive pulmonary disease or chronic respiratory condition
- 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.
- 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.
- Positive pregnancy test results for female subjects of childbearing potential or breast feeding.
- Enrollment in a concurrent clinical study that in the judgement of the investigator would impact study outcomes.
- 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.
- 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:
- Documented LA thrombus upon imaging
- Creatinine >2.5mg/dl or creatinine clearance <30mL/min
- Within 3 months of enrollment:
- Significant gastrointestinal (GI) bleed
- Myocardial infarction (MI), unstable angina, cardiac surgery or coronary intervention
- Within 6 months of enrollment:
- Coronary artery bypass graft (CABG) procedure
- Implant procedure performed for ICD, CRT leads or pacemaker
- Documented stroke, CVA, TIA or suspected neurological event
Trial locations and contacts
28 sites in 6 countries.
28 sites in 6 countries
United States15 sites
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, 78705
Grandview Medical Center
Birmingham, Alabama, 35242
University Of Alabama
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Trident Medical Center
Charleston, South Carolina, 29406
Medical University Of South Carolina
Charleston, South Carolina, 29425
Houston Methodist Hospital
Houston, Texas, 77030
Jackson Heart Clinic
Jackson, Mississippi, 39216
Keck School Of Medicine
Los Angeles, California, 90033
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Montefiore Medical Center
New York, New York, 10467
Advent Health, Florida Hospital Orlando
Orlando, Florida, 32751
Kansas City Heart Rhythm Institute
Overland Park, Kansas, 66211
North Mississippi Medical Center
Tupelo, Mississippi, 38801
Iowa Heart Center
West Des Moines, Iowa, 50266
France4 sites
CHRU Nancy
Nancy, 54511
Clinique Saint Pierre
Perpignan, 66000
Clinique Pasteur
Toulouse, 31076
Clinique du Tonkin
Villeurbanne, Lyon, 69100
Canada3 sites
Montreal Heart Institute
Montreal, Quebec, HITC8
Southlake Regional Health Center
Newmarket, Ontario, L3Y2P6
Institut Universitaire de Cardiologie et de Pneumologie de Québec (IUCPQ)
Québec, Quebec, G1V4G5
Czechia3 sites
St Ann's University Hospital
Brno, 65691
Institut Klinicke a Experimentalni Mediciny (IKEM)
Prague, Czechia, 14021
Na Homolce
Prague, Prague, 15000
Italy2 sites
Centro Cardiologico Monzino
Milan, Milano, 20138
Ospedale dell'Angelo
Venezia, 30174
About this study
Official title: 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.
Read the 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.
- Being tested
- Radiofrequency Ablation
- Keywords
- ablation, electrophysiology, atrial fibrillation, catheter, persistent
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency AblationDevice
A procedure will be performed using a radiofrequency ablation catheter.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Radiofrequency Ablation. Catheter ablation to treat persistent atrial fibrillation using temperature-controlled ablation catheter Receives: Device: Radiofrequency Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 12 months
Secondary outcomes (13)
Freedom From a Composite of Serious Adverse Events (SAEs)
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.
Measured: Within 30-days post-index ablation
Freedom From Documented AF/AFL/AT Episodes
Freedom from documented AF/AFL/AT episodes during the effectiveness evaluation period lasting ≥ 30 seconds in duration by ECG monitoring.
Measured: Within 3 months
Freedom From Documented AF/AFL/AT Episodes in the Absence of Class I and III Anti-arrhythmic Drug Therapy.
Freedom from documented AF/AFL/AT episodes during the effectiveness evaluation period in the absence of class I and III anti-arrhythmic drug therapy.
Measured: Within 3 months
Acute Procedural Success
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
Measured: Day of index ablation procedure
Single Procedure Success With Freedom From AF/AT/AFL
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.
Measured: 12 months after the index ablation procedure
Single Procedure Success With Freedom From All Primary Effectiveness Failures
Participant count of single procedure success with freedom from all primary effectiveness failure criteria.
Measured: 12 months
AFEQT Quality of Life, Baseline
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.
Measured: Day of index ablation procedure
AFEQT Quality of Life, 6-month Follow-up
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.
Measured: 6 months after index ablation procedure
AFEQT Quality of Life, 12-month Follow up
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.
Measured: 12 months after index ablation procedure
Change in AFEQT Quality of Life From Baseline to 12-month
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.
Measured: Index ablation procedure through 12 months
National Institutes of Health Stroke Scale, Pre-discharge
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.
Measured: Day of index ablation procedure
National Institutes of Health Stroke Scale, One- Month Follow up
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.
Measured: One month after index ablation procedure
National Institutes of Health Stroke Scale, 12-month Follow-up
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.
Measured: 12 months after the index ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start19 Sep 2018
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Persistent Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Ablation SolutionsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Ablation Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Atul Verma, MD, Principal investigator, Medical Director, Heart Rhythm Program, Southlake Regional Health CentreAndrea Natale, MD, Principal investigator, Director, Electrophysiology, Texas Cardiac Arrhythmia Institute at St. David's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643224
- Sponsor's protocol ID
- TP01071
- Acronym
- Diamond-AFII
- Status last verified
- Oct 2025
- First submitted
- 20 Aug 2018
- Last updated
- 23 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Evaluation of the DiamondTemp™ System for the Treatment of Persistent Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03643224
- Acronym / sponsor ID
- Diamond-AFII / TP01071
- Keywords
- ablation, electrophysiology, atrial fibrillation, catheter, persistent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- Medtronic Cardiac Ablation SolutionsIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Posted 23 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Radiofrequency AblationRadiofrequency Ablation. Catheter ablation to treat persistent atrial fibrillation using temperature-controlled ablation catheter |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency AblationA procedure will be performed using a radiofrequency ablation catheter. | Device | Experimental |
Primary outcome
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
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).
13 secondary outcomes
Freedom From a Composite of Serious Adverse Events (SAEs)
Time frame: 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 in the Absence of Class I and III Anti-arrhythmic Drug Therapy.
Time frame: Within 3 months
Acute Procedural Success
Time frame: Day of index ablation procedure
Single Procedure Success With Freedom From AF/AT/AFL
Time frame: 12 months after the index ablation procedure
Single Procedure Success With Freedom From All Primary Effectiveness Failures
Time frame: 12 months
AFEQT Quality of Life, Baseline
Time frame: Day of index ablation procedure
AFEQT Quality of Life, 6-month Follow-up
Time frame: 6 months after index ablation procedure
AFEQT Quality of Life, 12-month Follow up
Time frame: 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
National Institutes of Health Stroke Scale, Pre-discharge
Time frame: Day of index ablation procedure
National Institutes of Health Stroke Scale, One- Month Follow up
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atul Verma, MD principal investigator
Medical Director, Heart Rhythm Program, Southlake Regional Health Centre
Andrea Natale, MD principal investigator
Director, Electrophysiology, Texas Cardiac Arrhythmia Institute at St. David's Medical Center
28 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency Ablation in people with Persistent Atrial Fibrillation and Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 28 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, France, Canada, Czechia, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Safety Events (time frame: Ablation through 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2025.