Back to results

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

Primary Purpose

Atrial Fibrillation

Status

Completed

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

DiamondTemp Cardiac Ablation System

About this trial

This is an interventional treatment trial for Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Na Homolce
Clnique du Tonkin
CHRU de Nancy
Clinique Pasteur

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DiamondTemp Cardiac Ablation System

Arm Description

Cardiac ablation procedure

Outcomes

Primary Outcome Measures

Freedom from a composite of serious adverse events (SAE)

Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter(AFL) and atrial tachycardia (AT) episodes

Secondary Outcome Measures

Freedom from a composite SAE

Freedom from documented symptomatic and asymptomatic AF, AT and AFL episodes

Rate of single procedure success

Full Information

NCT ID

NCT03626649

First Posted

August 8, 2018

Last Updated

February 1, 2021

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

1. Study Identification

Unique Protocol Identification Number

NCT03626649

Brief Title

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

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Completed

Study Start Date

May 29, 2018 (Actual)

Primary Completion Date

August 8, 2019 (Actual)

Study Completion Date

August 8, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Cardiac Rhythm and Heart Failure

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atrial Fibrillation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

The DIAMOND FASTR-AF study is a prospective, single-arm trial being performed at multiple centers in Europe.

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DiamondTemp Cardiac Ablation System

Arm Type

Experimental

Arm Description

Cardiac ablation procedure

Intervention Type

Device

Intervention Name(s)

DiamondTemp Cardiac Ablation System

Other Intervention Name(s)

Cardiac ablation

Intervention Description

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

Primary Outcome Measure Information:

Title

Freedom from a composite of serious adverse events (SAE)

Description

Freedom from a composite of serious adverse events (SAE)

Time Frame

30 days

Title

Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter(AFL) and atrial tachycardia (AT) episodes

Description

Freedom from documented symptomatic atrial fibrillation (AF), atrial flutter(AFL) and atrial tachycardia (AT) episodes

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Freedom from a composite SAE

Description

Freedom from a composite SAE

Time Frame

7 days

Title

Freedom from documented symptomatic and asymptomatic AF, AT and AFL episodes

Description

Freedom from documented symptomatic and asymptomatic AF, AT and AFL episodes

Time Frame

12 months

Title

Rate of single procedure success

Description

Rate of single procedure success

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Petr Neuzil, MD, PhD

Organizational Affiliation

Na Homolce

Official's Role

Principal Investigator

Facility Information:

Facility Name

Na Homolce

City

Prague

ZIP/Postal Code

15000

Country

Czechia

Facility Name

Clnique du Tonkin

City

Lyon

Country

France

Facility Name

CHRU de Nancy

City

Nancy

Country

France

Facility Name

Clinique Pasteur

City

Toulouse

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35581464

Citation

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. 2023 Mar;66(2):343-351. doi: 10.1007/s10840-022-01234-9. Epub 2022 May 18.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs