Evaluation for the Characterization of the Safety Profile of the DiamondTemp™ System for Fast Treatment of Patients With Atrial Fibrillation (FASTR-AF)

Medtronic

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: DiamondTemp Cardiac Ablation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT03626649

TP00983

Details and patient eligibility

About

The objective of this study is to characterize the performance of the DiamondTemp Ablation System for its intended use.

Full description

• The DiamondTemp Ablation System is indicated for use in patients requiring cardiac electrophysiological mapping (stimulation and recording) and, when used in conjunction with a radiofrequency generator and irrigation pump, for cardiac ablation with monitoring of tissue temperature during ablation.
• In this study, the DiamondTemp Ablation System will be evaluated for the treatment of patients with atrial fibrillation.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Suitable candidate for intra-cardiac mapping and ablation for arrhythmias
• History of recurrent symptomatic PAF with ≥2 episodes reported within the 365 days
• (12) months prior to enrollment
• At least 1 episode of AF documented by Holter monitor, rhythm strip, trans-telephonic monitor (TTM), or 12-lead ECG prior to enrollment
• Refractory to at least one Class I-IV anti-arrhythmic drug (AAD)
• Eighteen (18) years of age or above

Exclusion criteria

• Previous left atrial ablation procedure
• Intracardiac thrombus, tumor or other abnormality that precludes catheter introduction and placement
• Known severe cerebrovascular disease or history of cerebrovascular event (< 1 month)
• Subjects with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR)3 with a GFR ≤ 29. Active gastrointestinal bleeding
• Active infection or fever (>100.5 F/38 ◦C)
• Sepsis
• Cardiac surgery within the past two months.
• Short life expectancy (<1 yr.) due to other illnesses, such as cancer or pulmonary, hepatic, or renal disease Significant anemia (hemoglobin < 8.0 mg/dL)
• Severe uncontrolled systemic hypertension (systolic pressure > 240 mm Hg within the last 30 days)
• Documented anaphylaxis during previous exposure to angiographic contrast media
• Uncontrolled congestive heart failure (NYHA1 Class III or IV)
• Unstable angina or acute myocardial infarction within the past three months
• Bleeding, clotting disorders, or known thrombosis
• Severe Peripheral vascular disease
• Uncontrolled diabetes
• Heart valve replacement
• Mitral clip (E-valve)
• Women who are of childbearing potential who are currently pregnant or not willing to use contraception for the duration of the study
• Active participation in another investigational protocol currently or the last 30 days
• Unable or unwilling to take anti-coagulants
• Unwilling or unable to comply with any protocol or follow up requirements

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

DiamondTemp Cardiac Ablation System

Experimental group

Description:

Cardiac ablation procedure

Treatment:

Device: DiamondTemp Cardiac Ablation System