Status:
COMPLETED
DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation
Lead Sponsor:
Medtronic Cardiac Ablation Solutions
Conditions:
Paroxysmal Atrial Fibrillation
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
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 i...
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...
Eligibility Criteria
Inclusion
- STUDY INCLUSION CRITERIA- Candidates must meet ALL the following criteria to be enrolled in the DIAMOND-AF study:
- 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.
- 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:
- 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.
- 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 2 months of enrollment:
- Regularly (uninterrupted) prescribed amiodarone.
- Within 3 months of enrollment:
- Significant GI bleed.
- MI, unstable angina, cardiac surgery or coronary intervention.
- Within 6 months of enrollment:
- CABG procedure.
- ICD, CRT leads or pacemaker implant procedure.
- Documented stroke, CVA, TIA or suspected neurological event.
- Within 12 months of enrollment:
- An episode of AF lasting \>7 days in duration.
Exclusion
Key Trial Info
Start Date :
November 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2019
Estimated Enrollment :
482 Patients enrolled
Trial Details
Trial ID
NCT03334630
Start Date
November 6 2017
End Date
December 3 2019
Last Update
February 13 2025
Active Locations (23)
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1
Grandview Medical Center
Birmingham, Alabama, United States, 35242
2
University Of Alabama
Birmingham, Alabama, United States, 35294
3
Keck School Of Medicine
Los Angeles, California, United States, 90033
4
Sequoia Hospital
Redwood City, California, United States, 94062