DiamondTemp™ Ablation System for the Treatment of Paroxysmal Atrial Fibrillation

Not Applicable

Completed

Conditions: Paroxysmal Atrial Fibrillation
Atrial Fibrillation

Interventions: Device: DiamondTemp Ablation catheter
Device: TactiCath Quartz Ablation catheter

Registration Number: NCT03334630

Lead Sponsor: Medtronic Cardiac Ablation Solutions

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 in patients.

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 effectiveness of the DiamondTemp System used for ablation in patients with paroxysmal atrial fibrillation (AF). Subjects will be randomized for treatment with either the DiamondTemp Ablation Catheter or the TactiCath™ Quartz Contact Force Ablation Catheter manufactured by Abbott. Patients will be followed for 12 months.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 482

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DiamondTemp Ablation Catheter	DiamondTemp Ablation catheter	Catheter ablation to treat paroxysmal atrial fibrillation using DiamondTemp temperature-controlled ablation catheter
TactiCath Quartz Ablation Catheter	TactiCath Quartz Ablation catheter	Catheter ablation to treat paroxysmal atrial fibrillation using TactiCath Quartz contact-force sensing ablation catheter

Primary Outcome Measures

Name	Time	Method
Safety: Freedom From a Composite of Pre-specified Serious Adverse Events (SAEs)	Within 30-days or 6-months after index ablation procedure	The primary safety endpoint is defined as freedom from a composite of serious adverse events (SAE) occurring within 30-days and clinically symptomatic pulmonary vein stenosis through 6-months post-index ablation procedure, as adjudicated by an independent Clinical Events Committee (CEC) for relatedness to the procedure or device. The primary safety device- or procedure-related SAE composite will be the combined rate of the following events: * Atrioesophageal fistula * Bleeding complication * Cardiac tamponade / perforation * Death * Extended hospitalization * Myocardial infarction * Pericarditis * Phrenic nerve paralysis * Pulmonary edema * Pulmonary vein stenosis * Stroke post-ablation * Thromboembolism * Transient ischemic attack (TIA) post-ablation * Vagal nerve injury * Vascular access complications
Effectiveness: Freedom From Documented Atrial Fibrillation(AF), Atrial Flutter(AFL) and Atrial Tachycardia(AT) Episodes Following the Blanking Period (3M Post-ablation) Through the End of the Effectiveness Evaluation Period (12M Post-ablation).	3-12M (3-12 months) after index ablation procedure	The primary effectiveness failure is defined by any of the following events: * Inability to electrically isolate all accessible targeted pulmonary veins during the ablation procedure * Documented episodes of AF, AFL or AT lasting ≥ 30 seconds in duration as evidenced by electrocardiographic data during the effectiveness evaluation period * DC cardioversion for AF, AFL or AT during the effectiveness evaluation period * A repeat ablation procedure to treat AF, AFL or AT during the effectiveness evaluation period * Use of a new or modification to existing Class I-IV anti-arrhythmic drug (AAD) regimen to treat AF, AFL or AT recurrence during the effectiveness evaluation period * Use of a non-study device for ablation of any AF targets during the index or repeat ablation procedure during the blanking period * More than one (1) repeat ablation procedure during the blanking period

Secondary Outcome Measures

Name	Time	Method
Total Fluid Infused Through the Ablation Catheter (mL)	Index ablation procedure	Total fluid infused through the assigned ablation catheter (mL) at index procedure
Mean Duration of Individual Radiofrequency (RF) Ablations (Seconds)	Index ablation procedure	Mean duration of individual RF ablations (seconds) during the index ablation procedure
Rate of Acute Procedural Success	Index ablation procedure	Rate of acute procedural success is defined as confirmation of electrical isolation of PVs via assessment of entrance block at least 20 minutes following the last ablation around the respective PV.
Rate of Single Procedure Success With Freedom From Documented AF, AT and AFL at 12 Months.	Index ablation procedure through 12-months after index ablation procedure	Rate of single procedure success is defined as the rate of subjects treated with one single ablation procedure during study participation and with freedom from documented AF, AT and AFL at 12 months.
Rate of Occurrence of Electrically Reconnected Pulmonary Veins (PVs)	Index ablation procedure	Rate of occurrence of electrically reconnected PVs following a 20-minute waiting period assessed by entrance block at index procedure.
Time to Achieve Initial Pulmonary Vein Isolation (PVI) (Minutes)	Index ablation procedure	Time to achieve initial PVI (minutes) at index procedure is defined as time of delivery of first RF ablation with the assigned ablation catheter until confirmation of PVI.
Total Fluoroscopy Time (Minutes)	Index ablation procedure	Total fluoroscopy time (minutes) at index procedure
Mean Cumulative RF Time Per Procedure (Minutes)	Index ablation procedure	Mean cumulative RF time per procedure (minutes) during the index ablation procedure
Freedom From a Composite of SAE Occurring Within 7-days	Within 7-days after the index ablation procedure	Freedom from a composite of SAE occurring within 7-days post-index ablation procedure as adjudicated by an independent CEC for relatedness to the procedure or device. The device- or procedure-related SAE composite will be the combined rate of the following events: * Atrioesophageal fistula * Bleeding complication * Cardiac tamponade / perforation * Death * Extended hospitalization * Myocardial infarction * Pericarditis * Phrenic nerve paralysis * Pulmonary edema * Pulmonary vein stenosis * Stroke post-ablation * Thromboembolism * Transient ischemic attack (TIA) post-ablation * Vagal nerve injury * Vascular access complications
Freedom From Documented AF, AT and AFL Episodes in the Absence of Class I and III Anti-arrhythmic Drugs (AADs).	3-12 months after index ablation procedure	Freedom from documented AF, AT and AFL episodes following the blanking period through 12-month follow-up post-ablation procedure in the absence of class I and III anti-arrhythmic drug therapy.
Rate of Single Procedure Success With Freedom From ALL Primary Effectiveness Endpoint Failure Criteria.	Index ablation procedure through 12-months after index ablation procedure	Rate of single procedure success is defined as the rate of subjects treated with one single ablation procedure during study participation and with freedom from ALL primary effectiveness endpoint failure criteria.
Total Procedure Time (Minutes)	Index ablation procedure	Total procedure time (minutes) at index procedure is defined as time of first assigned ablation catheter insertion into the vasculature to time of last procedural ablation catheter removed.
Total Treatment Device Time (Minutes)	Index ablation procedure	Total treatment device time (minutes) at index procedure is defined as time of delivery of first RF ablation with the assigned ablation treatment catheter to removal of the treatment catheter.
Neurological Changes Measured Using the National Institutes of Health Stroke Scale (NIHSS)	Baseline, pre-discharge after index ablation and 12-months after index ablation procedure	Neurological changes measured using the NIH stroke scale between baseline and post-ablation (pre-discharge visit) and at 12 months post-ablation procedure. The National Institutes of Health Stroke Scale (NIHSS) is a systematic assessment tool that provides a quantitative measure of stroke-related neurologic deficit. The total NIHSS score can range from 0 to 42, with 0 indicating no stroke symptoms and 42 indicating extremely severe stroke symptoms. So a higher NIHSS score means a worse outcome.
Number of Re-hospitalizations Due to Atrial Fibrillation Recurrence After Blanking Period	3-12 months after index ablation procedure	Number of re-hospitalizations due to atrial fibrillation recurrence after blanking period
Accumulated Changes in Quality of Life (QOL) Using the Atrial Fibrillation Effect on QualiTy-of-Life (AFEQT) Questionnaire	Baseline, 6-months after index ablation and 12-months after index ablation	Accumulated changes in QOL using the AF QOL Survey (AFEQT Questionnaire) from baseline through 6 and 12 months following ablation procedure. The Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire is an atrial fibrillation-specific health-related quality of life Questionnaire. The overall AFEQT score can range from 0 to 100, with 0 corresponding to complete disability and 100 corresponding to no disability. So a higher AFEQT score means a better outcome.
Total Number of RF Ablations Per Procedure	Index ablation procedure	Total number of RF ablations per procedure at index procedure

Trial Locations

Locations (23): Clinique du Tonkin
🇫🇷
Villeurbanne, Lyon, France
Grandview Medical Center
🇺🇸
Birmingham, Alabama, United States
Florida Hospital Orlando
🇺🇸
Orlando, Florida, United States
University Of Alabama
🇺🇸
Birmingham, Alabama, United States
Keck School Of Medicine
🇺🇸
Los Angeles, California, United States
Sequoia Hospital
🇺🇸
Redwood City, California, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Houston Methodist Research Institute
🇺🇸
Houston, Texas, United States
Na Homolce
🇨🇿
Praha, Prague, Czechia
Southlake Regional Medical Centre
🇨🇦
Toronto, Newmarket/Ontario, Canada
St Anne's University Hospital
🇨🇿
Brno, Czechia
Clinique Pasteur
🇫🇷
Toulouse, Cedex 3, France
Institut Klinicke a Experimentalni Mediciny (IKEM)
🇨🇿
Praha, Czechia
CHRU Nancy
🇫🇷
Nancy, France
Centro Cardiologico Monzino
🇮🇹
Milan, Milano, Italy
Ospedale dell'Angelo di Mestre
🇮🇹
Mestre, Venezia, Italy
Ochsner Medical Center
🇺🇸
New Orleans, Louisiana, United States
Jackson Heart Clinic
🇺🇸
Jackson, Mississippi, United States
Icahn School of Medicine at Mount Sinai
🇺🇸
New York, New York, United States
Medical University Of South Carolina
🇺🇸
Charleston, South Carolina, United States
Trident Medical Center
🇺🇸
Charleston, South Carolina, United States
Texas Cardiac Arrhythmia Research Foundation
🇺🇸
Austin, Texas, United States
Montefiore Medical Center
🇺🇸
New York, New York, United States