DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
NCT ID: NCT03334630
Last Updated: 2025-02-13
Study Results
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View full resultsBasic Information
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COMPLETED
NA
482 participants
INTERVENTIONAL
2017-11-06
2019-12-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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DiamondTemp Ablation Catheter
Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter
DiamondTemp Ablation catheter
a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
TactiCath Quartz Ablation Catheter
Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter
TactiCath Quartz Ablation catheter
a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Interventions
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DiamondTemp Ablation catheter
a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
TactiCath Quartz Ablation catheter
a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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.
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Ablation Solutions
INDUSTRY
Responsible Party
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Principal Investigators
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Josef Kautzner, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Institut klinické a experimentální medicíny (IKEM)
William Maddox, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Tom McElderry, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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Grandview Medical Center
Birmingham, Alabama, United States
University Of Alabama
Birmingham, Alabama, United States
Keck School Of Medicine
Los Angeles, California, United States
Sequoia Hospital
Redwood City, California, United States
Florida Hospital Orlando
Orlando, Florida, United States
Ochsner Medical Center
New Orleans, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Jackson Heart Clinic
Jackson, Mississippi, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Montefiore Medical Center
New York, New York, United States
Trident Medical Center
Charleston, South Carolina, United States
Medical University Of South Carolina
Charleston, South Carolina, United States
Texas Cardiac Arrhythmia Research Foundation
Austin, Texas, United States
Houston Methodist Research Institute
Houston, Texas, United States
Southlake Regional Medical Centre
Toronto, Newmarket/Ontario, Canada
Na Homolce
Prague, Prague, Czechia
St Anne's University Hospital
Brno, , Czechia
Institut Klinicke a Experimentalni Mediciny (IKEM)
Prague, , Czechia
Clinique Pasteur
Toulouse, Cedex 3, France
Clinique du Tonkin
Villeurbanne, Lyon, France
CHRU Nancy
Nancy, , France
Centro Cardiologico Monzino
Milan, Milano, Italy
Ospedale dell'Angelo di Mestre
Mestre, Venezia, Italy
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol: Revision I
Document Type: Study Protocol: Revision G
Document Type: Study Protocol: Revision F
Document Type: Study Protocol: Revision E
Document Type: Study Protocol: Revision D
Document Type: Study Protocol: Revision C
Document Type: Study Protocol: Revision H
Document Type: Statistical Analysis Plan
Other Identifiers
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TP00599
Identifier Type: -
Identifier Source: org_study_id
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