DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation

NCT03334630 | Completed Results DMC FDA Device

• 1 other identifier: TP00599
• Study Type: interventional
• Target: 482
• Locations: 5 countries
• Sites: 23

Brief 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.

Conditions

Paroxysmal Atrial Fibrillation; Atrial Fibrillation

Keywords

ablation; electrophysiology; atrial fibrillation; catheter; paroxysmal

Outcome Measures

Primary Outcomes (2)

• 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

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

• 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

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

Secondary Outcomes (17)

• Mean Duration of Individual Radiofrequency (RF) Ablations (Seconds)

  Index ablation procedure

• Mean Cumulative RF Time Per Procedure (Minutes)

  Index ablation procedure

• Freedom From a Composite of SAE Occurring Within 7-days

  Within 7-days after the index ablation procedure

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

  3-12 months after index ablation procedure

• Rate of Acute Procedural Success

  Index ablation procedure

Study Arms (2)

DiamondTemp Ablation Catheter

EXPERIMENTAL

Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter

Device: DiamondTemp Ablation catheter

TactiCath Quartz Ablation Catheter

ACTIVE COMPARATOR

Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter

Device: TactiCath Quartz Ablation catheter

Interventions

DiamondTemp Ablation catheter DEVICE

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

DiamondTemp Ablation Catheter

TactiCath Quartz Ablation catheter DEVICE

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

TactiCath Quartz Ablation Catheter

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 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.
• At least one episode of PAF documented by electrocardiographic data within the 12 months prior to index ablation procedure.
• Refractory to at least one Class I-IV AAD for treatment of PAF.
• 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:
• AF secondary to electrolyte imbalance, thyroid disease or reversible or non-cardiac cause.
• LA diameter \> 5.5 cm.
• LVEF \< 35%.
• Currently NYHA Class III or IV or exhibits uncontrolled heart failure.
• BMI \> 40 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°F / 38°C) 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.

Sponsors & Collaborators

• Medtronic Cardiac Ablation Solutions: lead

Study Sites (23)

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

Sequoia Hospital

Redwood City, California, 94062, United States

Location

Florida Hospital Orlando

Orlando, Florida, 32803, United States

Location

Ochsner Medical Center

New Orleans, Louisiana, 70121, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, 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 Research Institute

Houston, Texas, 77030, United States

Location

Southlake Regional Medical Centre

Toronto, Newmarket/Ontario, L3Y 2P9, Canada

Location

Na Homolce

Prague, Prague, 15000, Czechia

Location

St Anne's University Hospital

Brno, 65691, Czechia

Location

Institut Klinicke a Experimentalni Mediciny (IKEM)

Prague, 14021, Czechia

Location

Clinique Pasteur

Toulouse, Cedex 3, 31076, France

Location

Clinique du Tonkin

Villeurbanne, Lyon, 69100, France

Location

CHRU Nancy

Nancy, 54511, France

Location

Centro Cardiologico Monzino

Milan, Milano, 20138, Italy

Location

Ospedale dell'Angelo di Mestre

Mestre, Venezia, 30174, Italy

Location

Related Publications (2)

• 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.

  PMID: 28750697 BACKGROUND

• 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.

  PMID: 33516712 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Katie Flor, Principal Clinical Research Specialist
• Organization: Medtronic

katie.j.flor@medtronic.com

+1 763 526 9651

Study Officials

• Josef Kautzner, MD, PhD

  Institut klinické a experimentální medicíny (IKEM)

  PRINCIPAL INVESTIGATOR

• William Maddox, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Tom McElderry, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 7, 2017
• Study Start: November 6, 2017
• Primary Completion: November 18, 2019
• Study Completion: December 3, 2019
• Last Updated: February 13, 2025
• Results First Posted: December 9, 2020

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (14); CA (1); CZ (3); FR (3); IT (2)