Evaluation for the Characterization of the Safety Profile of the DiamondTemp™ System for Fast Treatment of Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— FASTR-AF  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03626649
• Other study ID #: TP00983
• Status: Completed
• Phase: N/A
• Start date: May 29, 2018
• Est. completion date: August 8, 2019

Study information

• Verified date: February 2021
• Source: Medtronic Cardiac Rhythm and Heart Failure
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 8, 2019
• Est. primary completion date: August 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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 Catheter o Unidirectional and Bidirectional models DiamondTemp Catheter-to RFG Cable DiamondTemp GenConnect Cable DiamondTemp FASTR Generator with Footswitch DiamondTemp Irrigation Pump DiamondTemp Irrigation Tubing Set

Locations

Country	Name	City	State
Czechia	Na Homolce	Prague
France	Clnique du Tonkin	Lyon
France	CHRU de Nancy	Nancy
France	Clinique Pasteur	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

Czechia,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from a composite of serious adverse events (SAE)	Freedom from a composite of serious adverse events (SAE)	30 days
Primary	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	Freedom from a composite SAE	Freedom from a composite SAE	7 days
Secondary	Freedom from documented symptomatic and asymptomatic AF, AT and AFL episodes	Freedom from documented symptomatic and asymptomatic AF, AT and AFL episodes	12 months
Secondary	Rate of single procedure success	Rate of single procedure success	12 months