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

A Prospective Single Arm Clinical Evaluation for the Characterization of the Safety Profile of the DiamondTemp™ System for Fast Treatment of Patients With Atrial Fibrillation

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

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Device: DiamondTemp Cardiac Ablation System

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Prague, Czechia, 15000
    • Na Homolce
• France
  • Lyon, France
    • Clnique du Tonkin
  • Nancy, France
    • CHRU de Nancy
  • Toulouse, France
    • Clinique Pasteur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: DiamondTemp Cardiac Ablation System; Cardiac ablation procedure

Device: DiamondTemp Cardiac Ablation System; The DiamondTemp Ablation System is the test device in this investigational study. The DiamondTemp Ablation System consists of: DiamondTemp Ablation Cathetero Unidirectional and Bidirectional models; DiamondTemp Catheter-to RFG Cable; DiamondTemp GenConnect Cable; DiamondTemp FASTR Generator with Footswitch; DiamondTemp Irrigation Pump; DiamondTemp Irrigation Tubing Set; Other Names: Cardiac ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from a composite of serious adverse events (SAE)	Freedom from a composite of serious adverse events (SAE)	30 days
Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter(AFL) and atrial tachycardia (AT) episodes	Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter(AFL) and atrial tachycardia (AT) episodes	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Freedom from a composite SAE	Freedom from a composite SAE	7 days
Freedom from documented symptomatic and asymptomatic AF, AT and AFL episodes	Freedom from documented symptomatic and asymptomatic AF, AT and AFL episodes	12 months
Rate of single procedure success	Rate of single procedure success	12 months

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure
• Investigators: Principal Investigator: Petr Neuzil, MD, PhD, Na Homolce

Publications and helpful links

General Publications

• Neuzil P, Poty H, de Chillou C, Petru J, Getman MK, Liu S, Funasako M, Durand-Dubief A, Combes S, Albenque JP. Radiofrequency ablation using the second-generation temperature-controlled diamond tip system in paroxysmal and persistent atrial fibrillation: results from FASTR-AF. J Interv Card Electrophysiol. 2022 May 18. doi: 10.1007/s10840-022-01234-9. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2018
• Primary Completion (Actual): August 8, 2019
• Study Completion (Actual): August 8, 2019

Study Registration Dates

• First Submitted: August 8, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: TP00983

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No