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Paroxysmal Atrial FibrillationDIAMOND-AFNCT03334630

DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation

A study testing DiamondTemp Ablation catheter and TactiCath Quartz Ablation catheter in people with Paroxysmal Atrial Fibrillation and Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 23 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of the DIAMOND-AF study is to establish the safety and effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation in patients. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
DiamondTemp Ablation catheter and TactiCath Quartz Ablation catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
482 participants
Where
23 sitesin 5 countries
Study dates
6 Nov 2017to 3 Dec 2019
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

STUDY INCLUSION CRITERIA- Candidates must meet ALL the following criteria to be enrolled in the DIAMOND-AF study:

  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 symptomatic, paroxysmal atrial fibrillation (PAF) who have had ≥2 episodes of PAF reported within the 6 months prior to index ablation procedure with a physician note indicating recurrent, self-terminating AF.
  3. At least one episode of PAF documented by electrocardiographic data within the 12 months prior to index ablation procedure.
  4. Refractory to at least one Class I-IV AAD for treatment of PAF.
  5. Suitable candidate for intra-cardiac mapping and ablation of arrhythmia.
  6. Subject agrees to comply with study procedures and be available (geographically stable) for follow-up visits for at least 12 months after enrollment.
  7. Subject is willing and able to provide written consent.

STUDY EXCLUSION CRITERIA - Candidates will be excluded from the DIAMOND-AF study if any of the following conditions apply within the following timeframes:

At time of enrollment and/or prior to procedure:

  1. AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause.
  2. LA diameter > 5.5 cm.
  3. LVEF < 35%.
  4. Currently NYHA Class III or IV or exhibits uncontrolled heart failure.
  5. BMI > 40 kg/m2.
  6. LA ablation, septal closure device or mitral valve surgical procedure at any time prior to enrollment.
  7. Presence of intramural thrombus, tumor or abnormality that precludes vascular access, catheter introduction or manipulation.
  8. Coagulopathy, bleeding diathesis or suspected procoagulant state
  9. Sepsis, active systemic infection or fever (>100.5°F / 38°C) within a week prior to the ablation procedure.
  10. Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
  11. 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.
  12. 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.
  13. Positive pregnancy test results for female subjects of childbearing potential or breast feeding.
  14. Enrollment in a concurrent clinical study that in the judgement of the investigator would impact study outcomes.
  15. 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.
  16. 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:
  17. Documented LA thrombus upon imaging.
  18. Creatinine >2.5mg/dl or creatinine clearance <30mL/min. Within 2 months of enrollment:
  19. Regularly (uninterrupted) prescribed amiodarone. Within 3 months of enrollment:
  20. Significant GI bleed.
  21. MI, unstable angina, cardiac surgery or coronary intervention. Within 6 months of enrollment:
  22. CABG procedure.
  23. ICD, CRT leads or pacemaker implant procedure.
  24. Documented stroke, CVA, TIA or suspected neurological event. Within 12 months of enrollment:
  25. An episode of AF lasting >7 days in duration.

Trial locations and contacts

23 sites in 5 countries.

23 sites in 5 countries

United States14 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 Research Institute

    Houston, Texas, 77030

  • Jackson Heart Clinic

    Jackson, Mississippi, 39216

  • Keck School Of Medicine

    Los Angeles, California, 90033

  • Ochsner Medical Center

    New Orleans, Louisiana, 70121

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Montefiore Medical Center

    New York, New York, 10467

  • Florida Hospital Orlando

    Orlando, Florida, 32803

  • Sequoia Hospital

    Redwood City, California, 94062

Other trials in United States

Czechia3 sites

  • St Anne's University Hospital

    Brno, 65691

  • Na Homolce

    Prague, Prague, 15000

  • Institut Klinicke a Experimentalni Mediciny (IKEM)

    Prague, 14021

Other trials in Czechia

France3 sites

  • CHRU Nancy

    Nancy, 54511

  • Clinique Pasteur

    Toulouse, Cedex 3, 31076

  • Clinique du Tonkin

    Villeurbanne, Lyon, 69100

Other trials in France

Italy2 sites

  • Ospedale dell'Angelo di Mestre

    Mestre, Venezia, 30174

  • Centro Cardiologico Monzino

    Milan, Milano, 20138

Other trials in Italy

Canada1 site

  • Southlake Regional Medical Centre

    Toronto, Newmarket/Ontario, L3Y 2P9

Other trials in Canada

About this study

Official title: A Randomized Controlled Clinical Evaluation of the DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation

The purpose of the DIAMOND-AF study is to establish the safety and effectiveness of the DiamondTemp System for the treatment of drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation in patients.

Read the detailed description

The DIAMOND-AF study is a prospective, single blind, 1:1 randomized controlled study being performed at multiple centers in the United States, Canada and Europe. The study will evaluate the safety and effectiveness of the DiamondTemp System used for ablation in patients with paroxysmal atrial fibrillation (AF). Subjects will be randomized for treatment with either the DiamondTemp Ablation Catheter or the TactiCath™ Quartz Contact Force Ablation Catheter manufactured by Abbott. Patients will be followed for 12 months.

Being tested
DiamondTemp Ablation catheter, TactiCath Quartz Ablation catheter
Keywords
ablation, electrophysiology, atrial fibrillation, catheter, paroxysmal
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DiamondTemp Ablation catheterDevice

    a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

  • TactiCath Quartz Ablation catheterDevice

    a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter

Study groups in NCT03334630
Study groupRoleWhat they receive
DiamondTemp Ablation CatheterExperimentalCatheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter
Receives: Device: DiamondTemp Ablation catheter
TactiCath Quartz Ablation CatheterActive comparatorCatheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter
Receives: Device: TactiCath Quartz Ablation catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety: Freedom From a Composite of Pre-specified Serious Adverse Events (SAEs)

    The primary safety endpoint is defined as freedom from a composite of serious adverse events (SAE) occurring within 30-days and clinically symptomatic pulmonary vein stenosis through 6-months post-index ablation procedure, as adjudicated by an independent Clinical Events Committee (CEC) for relatedness to the procedure or device.

    The primary safety device- or procedure-related SAE composite will be the combined rate of the following events:

    • Atrioesophageal fistula
    • Bleeding complication
    • Cardiac tamponade / perforation
    • Death
    • Extended hospitalization
    • Myocardial infarction
    • Pericarditis
    • Phrenic nerve paralysis
    • Pulmonary edema
    • Pulmonary vein stenosis
    • Stroke post-ablation
    • Thromboembolism
    • Transient ischemic attack (TIA) post-ablation
    • Vagal nerve injury
    • Vascular access complications

    Measured: Within 30-days or 6-months after index ablation procedure

  2. Effectiveness: Freedom From Documented Atrial Fibrillation(AF), Atrial Flutter(AFL) and Atrial Tachycardia(AT) Episodes Following the Blanking Period (3M Post-ablation) Through the End of the Effectiveness Evaluation Period (12M Post-ablation).

    The primary effectiveness failure is defined by any of the following events:

    • Inability to electrically isolate all accessible targeted pulmonary veins during the ablation procedure
    • Documented episodes of AF, AFL or AT lasting ≥ 30 seconds in duration as evidenced by electrocardiographic data during the effectiveness evaluation period
    • DC cardioversion for AF, AFL or AT during the effectiveness evaluation period
    • A repeat ablation procedure to treat AF, AFL or AT during the effectiveness evaluation period
    • Use of a new or modification to existing Class I-IV anti-arrhythmic drug (AAD) regimen to treat AF, AFL or AT recurrence during the effectiveness evaluation period
    • Use of a non-study device for ablation of any AF targets during the index or repeat ablation procedure during the blanking period
    • More than one (1) repeat ablation procedure during the blanking period

    Measured: 3-12M (3-12 months) after index ablation procedure

Secondary outcomes (17)

  1. Mean Duration of Individual Radiofrequency (RF) Ablations (Seconds)

    Mean duration of individual RF ablations (seconds) during the index ablation procedure

    Measured: Index ablation procedure

  2. Mean Cumulative RF Time Per Procedure (Minutes)

    Mean cumulative RF time per procedure (minutes) during the index ablation procedure

    Measured: Index ablation procedure

  3. Freedom From a Composite of SAE Occurring Within 7-days

    Freedom from a composite of SAE occurring within 7-days post-index ablation procedure as adjudicated by an independent CEC for relatedness to the procedure or device.

    The device- or procedure-related SAE composite will be the combined rate of the following events:

    • Atrioesophageal fistula
    • Bleeding complication
    • Cardiac tamponade / perforation
    • Death
    • Extended hospitalization
    • Myocardial infarction
    • Pericarditis
    • Phrenic nerve paralysis
    • Pulmonary edema
    • Pulmonary vein stenosis
    • Stroke post-ablation
    • Thromboembolism
    • Transient ischemic attack (TIA) post-ablation
    • Vagal nerve injury
    • Vascular access complications

    Measured: Within 7-days after the index ablation procedure

  4. Freedom From Documented AF, AT and AFL Episodes in the Absence of Class I and III Anti-arrhythmic Drugs (AADs).

    Freedom from documented AF, AT and AFL episodes following the blanking period through 12-month follow-up post-ablation procedure in the absence of class I and III anti-arrhythmic drug therapy.

    Measured: 3-12 months after index ablation procedure

  5. Rate of Acute Procedural Success

    Rate of acute procedural success is 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: Index ablation procedure

  6. Rate of Single Procedure Success With Freedom From Documented AF, AT and AFL at 12 Months.

    Rate of single procedure success is defined as the rate of subjects treated with one single ablation procedure during study participation and with freedom from documented AF, AT and AFL at 12 months.

    Measured: Index ablation procedure through 12-months after index ablation procedure

  7. Rate of Single Procedure Success With Freedom From ALL Primary Effectiveness Endpoint Failure Criteria.

    Rate of single procedure success is defined as the rate of subjects treated with one single ablation procedure during study participation and with freedom from ALL primary effectiveness endpoint failure criteria.

    Measured: Index ablation procedure through 12-months after index ablation procedure

  8. Rate of Occurrence of Electrically Reconnected Pulmonary Veins (PVs)

    Rate of occurrence of electrically reconnected PVs following a 20-minute waiting period assessed by entrance block at index procedure.

    Measured: Index ablation procedure

  9. Accumulated Changes in Quality of Life (QOL) Using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire

    Accumulated changes in QOL using the AF QOL Survey (AFEQT Questionnaire) from baseline through 6 and 12 months following ablation procedure.

    The Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire is an atrial fibrillation-specific health-related quality of life Questionnaire. The overall AFEQT score can range from 0 to 100, with 0 corresponding to complete disability and 100 corresponding to no disability. So a higher AFEQT score means a better outcome.

    Measured: Baseline, 6-months after index ablation and 12-months after index ablation

  10. Neurological Changes Measured Using the National Institutes of Health Stroke Scale (NIHSS)

    Neurological changes measured using the NIH stroke scale between baseline and post-ablation (pre-discharge visit) and at 12 months post-ablation procedure.

    The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The total NIHSS score can range from 0 to 42, with 0 indicating no stroke symptoms and 42 indicating extremely severe stroke symptoms. So a higher NIHSS score means a worse outcome.

    Measured: Baseline, pre-discharge after index ablation and 12-months after index ablation procedure

  11. Total Procedure Time (Minutes)

    Total procedure time (minutes) at index procedure is defined as time of first assigned ablation catheter insertion into the vasculature to time of last procedural ablation catheter removed.

    Measured: Index ablation procedure

  12. Time to Achieve Initial Pulmonary Vein Isolation (PVI) (Minutes)

    Time to achieve initial PVI (minutes) at index procedure is defined as time of delivery of first RF ablation with the assigned ablation catheter until confirmation of PVI.

    Measured: Index ablation procedure

  13. Total Treatment Device Time (Minutes)

    Total treatment device time (minutes) at index procedure is defined as time of delivery of first RF ablation with the assigned ablation treatment catheter to removal of the treatment catheter.

    Measured: Index ablation procedure

  14. Total Number of RF Ablations Per Procedure

    Total number of RF ablations per procedure at index procedure

    Measured: Index ablation procedure

  15. Total Fluid Infused Through the Ablation Catheter (mL)

    Total fluid infused through the assigned ablation catheter (mL) at index procedure

    Measured: Index ablation procedure

  16. Total Fluoroscopy Time (Minutes)

    Total fluoroscopy time (minutes) at index procedure

    Measured: Index ablation procedure

  17. Number of Re-hospitalizations Due to Atrial Fibrillation Recurrence After Blanking Period

    Number of re-hospitalizations due to atrial fibrillation recurrence after blanking period

    Measured: 3-12 months after index ablation procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2017
  2. Study start6 Nov 2017
  3. Primary completion18 Nov 2019
  4. Study completion3 Dec 2019

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
482 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03334630
Sponsor's protocol ID
TP00599
Acronym
DIAMOND-AF
Status last verified
Feb 2025
First submitted
24 Oct 2017
Last updated
13 Feb 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Iwasawa J, Koruth JS, Petru J, Dujka L, Kralovec S, Mzourkova K, Dukkipati SR, Neuzil P, Reddy VY. Temperature-Controlled Radiofrequency Ablation for Pulmonary Vein Isolation in Patients With Atrial Fibrillation. J Am Coll Cardiol. 2017 Aug 1;70(5):542-553. doi: 10.1016/j.jacc.2017.06.008.

    PubMed 28750697

  • Kautzner J, Albenque JP, Natale A, Maddox W, Cuoco F, Neuzil P, Poty H, Getman MK, Liu S, Starek Z, Dukkipati SR, Colley BJ 3rd, Al-Ahmad A, Sidney DS, McElderry HT. A Novel Temperature-Controlled Radiofrequency Catheter Ablation System Used to Treat Patients With Paroxysmal Atrial Fibrillation. JACC Clin Electrophysiol. 2021 Mar;7(3):352-363. doi: 10.1016/j.jacep.2020.11.009. Epub 2021 Jan 27.

    PubMed 33516712

Questions about this trial

What is this clinical trial studying?

A study testing DiamondTemp Ablation catheter and TactiCath Quartz Ablation catheter in people with Paroxysmal Atrial Fibrillation and Atrial Fibrillation, run by Medtronic Cardiac Ablation Solutions at 23 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Czechia, France, Italy, Canada. 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 9 Dec 2020). 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?

Safety: Freedom From a Composite of Pre-specified Serious Adverse Events (SAEs) (time frame: Within 30-days or 6-months after index ablation procedure). 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?

On the ClinicalTrials.gov record for NCT03334630, which also lists 2 linked publications.

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 13 Feb 2025.

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