Clinical Study for Workflow and Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System for Treating Symptomatic Paroxysmal AF (QDOT-Micro)

• Sponsor: Biosense Webster, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02944968
• Collaborator: (none)
• Enrollment: 51
• Locations: 6
• Arm: 1
• Actual Duration (Months): 23.1
• Patients Per Site: 8.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

The QDOT-Micro study is a prospective, multi-center, non-randomized, interventional clinical study.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Device: THERMOCOOL SMARTTOUCH® SF-5D catheter	N/A

Detailed Description

The purpose of this study is to evaluate the workflow and acute performance , during standard electrophysiology mapping and RF ablation procedures, of the THERMOCOOL SMARTTOUCH® SF-5D catheter with temperature sensing capabilities and micro electrodes used in combination with the CARTO® 3 Navigation System with THERMOCOOL SMARTTOUCH® SF-5D-module.

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Study for Workflow and Acute Performance Evaluation of the THERMOCOOL SMARTTOUCH® SF-5D System (the THERMOCOOL SMARTTOUCH® SF-5D Catheter With Temperature Sensing Capabilities and Micro Electrodes and CARTO 3 V 6.0 Technology) in Treatment of Patients With Paroxysmal Atrial Fibrillation (QDOT-Micro)
• Actual Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Aug 6, 2018
• Actual Study Completion Date: Aug 6, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment group Radiofrequency ablation treatment with the THERMOCOOL SMARTTOUCH® SF-5D catheter in Paroxysmal AF population.	Device: THERMOCOOL SMARTTOUCH® SF-5D catheter

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Entrance Block Confirmation in the Total Effectiveness Outcome Population [Day of ablation procedure]

   Confirmation of entrance block in all targeted PVs after adenosine and/or isoproterenol challenge achieved at the end of procedure. If the challenge was not done, confirmation data would not be available.

Secondary Outcome Measures

1. Number of Participants With Early Onset Primary Adverse Events in Total Safety Population [Seven Days Post Procedure]

   Primary adverse events include Death, Atrio-Esophageal Fistula, Cardiac Tamponade/Perforation, Myocardial Infarction, Stroke/Cerebrovascular Accident, Thromboembolism, Transient Ischemic Attack, Diaphragmatic Paralysis, Pneumothorax, Heart Block, Pulmonary Vein Stenosis, Pulmonary Edema (Respiratory Insufficiency), Vagal Nerve Injury, Pericarditis, Major Vascular Access Complication/Bleeding, Pulmonary vein (PV) stenosis and atrio-esophageal fistula

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Candidates for this study must meet ALL of the following criteria:

1. Age 18 or older

2. Patients who have signed the Patient Informed Consent Form (ICF)

3. Subjects diagnosed with symptomatic documented PAF* who are candidates for catheter ablation

4. Able and willing to comply with all pre-, post-, and follow-up testing and requirements (eg. Patient not confined by a court ruling)

Exclusion Criteria:

Candidates for this study will be EXCLUDED from the study if ANY of the following conditions apply:

1. Atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.

2. Previous ablation for atrial fibrillation.

3. Previously diagnosed with persistent AF.

4. Documented Left Atrial thrombus

5. Any carotid stenting or endarterectomy

6. LA size >50mm

7. LVEF <40%

8. Uncontrolled heart failure or NYHA function class III and IV

9. History of blood clotting or bleeding abnormalities or contraindication to anticoagulation ( heparin, warfarin, or dabigatran)

10. History of a documented thromboembolic event (including TIA) within the past 12 months.

11. Previous PCI/MI within the past 3 months

12. Previous cardiac surgery (e.g CABG) in conjunction with valve surgery or any valvular cardiac surgical/percutaneous procedure (e.g ventriculotomy, atriomy, valve repair or replacement, presence of a prosthetic valve) within the past 6 months.

13. Awaiting cardiac transplantation or other cardiac surgery within the next 6 months.

14. Unstable angina

15. Significant pulmonary disease (eg, restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.

16. Acute illness, active systemic infection, or sepsis.

17. Presence of intracardiac thrombus, myxoma, tumor, interatrial baffle or patch or other abnormality that precludes catheter introduction or manipulation.

18. Presence of a condition that precludes vascular access.

19. Presence of implantable cardioverter-defibrillator (ICD)

20. Significant congenital anomaly or a medical problem that in the opinion of the investigator would preclude enrollment in this trial.

21. Currently enrolled in an investigational study evaluating another device, biologics, or drug.

22. Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation (as evidenced by pregnancy test if of child bearing potential).

23. Life expectancy less than 12 months.

24. Presenting contra-indication for the devices used in the study, as indicated in the respective instructions for use.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	OLV Hospital Aalst	Aalst		Belgium	9300
2	Jessa Hospital	Hasselt		Belgium
3	IKEM	Prague		Czechia
4	Na Homolce Hospital	Prague		Czechia
5	Skejby _ Aarhus University hospital	Aarhus		Denmark
6	Ospedale Generale Regionale F Miulli	Bari		Italy

Sponsors and Collaborators

• Biosense Webster, Inc.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Nov 17, 2017
• Statistical Analysis Plan - Aug 2, 2018

More Information

Publications

None provided.

• Responsible Party: Biosense Webster, Inc.
• ClinicalTrials.gov Identifier: NCT02944968
• Other Study ID Numbers: MQDT-166
• First Posted: Oct 26, 2016
• Last Update Posted: Nov 25, 2019
• Last Verified: Nov 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Biosense Webster, Inc.: Interventional; Radiofrequency Ablation; Paroxysmal Atrial Fibrillation
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

Participant Flow

Recruitment Details	A total of 51 subjects were enrolled in the study at 6 sites in Europe. The first subject was enrolled on September 28th, 2016 and the last subject was enrolled on April 26th, 2018.
Pre-assignment Detail	Subjects were screened carefully prior to enrollment in the study to ensure compliance with the inclusion and exclusion criteria. All subjects had pre-procedure imaging to screen for the presence of left atrial appendage thrombus to decrease the potential for thromboembolic complications.

Arm/Group Title	THERMOCOOL SMARTTOUCH® SF-5D
Arm/Group Description	The THERMOCOOL SMARTTOUCH® SF-5D Catheter with improved temperature sensing capabilities and micro electrodes and CARTO®3 V6 technology
Period Title: Overall Study
STARTED	51
COMPLETED	48
NOT COMPLETED	3

Baseline Characteristics

Arm/Group Title	THERMOCOOL SMARTTOUCH® SF-5D
Arm/Group Description	The THERMOCOOL SMARTTOUCH® SF-5D Catheter with improved temperature sensing capabilities and micro electrodes and CARTO®3 V6 technology
Overall Participants	51
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	61.3 (11.92)
Sex: Female, Male (Count of Participants)
Female	19 37.3%
Male	32 62.7%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Number) [Number]
European Union	51 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Entrance Block Confirmation in the Total Effectiveness Outcome Population
Description	Confirmation of entrance block in all targeted PVs after adenosine and/or isoproterenol challenge achieved at the end of procedure. If the challenge was not done, confirmation data would not be available.
Time Frame	Day of ablation procedure

Outcome Measure Data

Analysis Population Description

This total effectiveness outcome population includes all subjects (under both protocols v1.0 and v2.0), complied with study inclusion and exclusion criteria, received investigational device, and had an adenosine challenge applied for verifying entrance block.

Arm/Group Title	THERMOCOOL SMARTTOUCH® SF-5D
Arm/Group Description	The THERMOCOOL SMARTTOUCH® SF-5D Catheter with improved temperature sensing capabilities and micro electrodes and CARTO®3 V6 technology
Measure Participants	47
Subjects with entrance block confirmation	46 90.2%
Subjects without entrance block confirmation	1 2%

2. Secondary Outcome

Title	Number of Participants With Early Onset Primary Adverse Events in Total Safety Population
Description	Primary adverse events include Death, Atrio-Esophageal Fistula, Cardiac Tamponade/Perforation, Myocardial Infarction, Stroke/Cerebrovascular Accident, Thromboembolism, Transient Ischemic Attack, Diaphragmatic Paralysis, Pneumothorax, Heart Block, Pulmonary Vein Stenosis, Pulmonary Edema (Respiratory Insufficiency), Vagal Nerve Injury, Pericarditis, Major Vascular Access Complication/Bleeding, Pulmonary vein (PV) stenosis and atrio-esophageal fistula
Time Frame	Seven Days Post Procedure

Outcome Measure Data

Analysis Population Description

Total Safety Population: includes subjects enrolled under CIP v1.0 and 2.0 who underwent study procedure with investigational device.

Arm/Group Title	THERMOCOOL SMARTTOUCH® SF-5D
Arm/Group Description	The THERMOCOOL SMARTTOUCH® SF-5D Catheter with improved temperature sensing capabilities and micro electrodes and CARTO®3 V6 technology
Measure Participants	50
Subjects with Pericard. effusion without tamponade	1 2%
Subjects with Pericarditis	1 2%
Subjects with Vascular pseudoaneurysm	1 2%
Subjects without primary adverse events	47 92.2%

Adverse Events

Time Frame	Three months follow up after procedure
Adverse Event Reporting Description	An AE is any untoward medical occurrence/clinical sign/unintended disease/injury in subjects/users/other persons, related or not to the investigational device.
Arm/Group Title	THERMOCOOL SMARTTOUCH® SF-5D
Arm/Group Description	The THERMOCOOL SMARTTOUCH® SF-5D Catheter with improved temperature sensing capabilities and micro electrodes and CARTO®3 V6 technology
All Cause Mortality
	THERMOCOOL SMARTTOUCH® SF-5D
	Affected / at Risk (%)	# Events
Total	0/50 (0%)
Serious Adverse Events
	THERMOCOOL SMARTTOUCH® SF-5D
	Affected / at Risk (%)	# Events
Total	7/50 (14%)
Cardiac disorders
Arrhythmia supraventricular	1/50 (2%)	1
Atrial flutter	1/50 (2%)	1
Pericarditis	1/50 (2%)	1
Atrial fibrillation	1/50 (2%)	1
Infections and infestations
Influenza	1/50 (2%)	1
Localised infection	1/50 (2%)	1
Injury, poisoning and procedural complications
Vascular pseudoaneurysm	1/50 (2%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer	1/50 (2%)	1
Other (Not Including Serious) Adverse Events
	THERMOCOOL SMARTTOUCH® SF-5D
	Affected / at Risk (%)	# Events
Total	22/50 (44%)
Blood and lymphatic system disorders
Lymphadenopathy mediastinal	1/50 (2%)	1
Cardiac disorders
Atrial flutter	1/50 (2%)	1
Atrial tachycardia	1/50 (2%)	1
Palpitations	2/50 (4%)	2
Pericarditis	1/50 (2%)	1
Endocrine disorders
Thyroid disorder	1/50 (2%)	1
Eye disorders
Visual impairment	1/50 (2%)	1
Gastrointestinal disorders
Abdominal pain	1/50 (2%)	1
Rectal haemorrhage	1/50 (2%)	1
General disorders
Chest pain	6/50 (12%)	6
Malaise	1/50 (2%)	1
Pyrexia	1/50 (2%)	1
Perforation	1/50 (2%)	1
Immune system disorders
Hypersensitivity	1/50 (2%)	1
Infections and infestations
Influenza	1/50 (2%)	1
Pneumonia	1/50 (2%)	1
Musculoskeletal and connective tissue disorders
Back pain	1/50 (2%)	1
Nervous system disorders
Cerebrovascular accident	1/50 (2%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea	4/50 (8%)	4
Sleep apnoea syndrome	1/50 (2%)	1
Vascular disorders
Haematoma	5/50 (10%)	5
Hypotension	1/50 (2%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between the Principal Investigator (PI)/Institution and the Sponsor (or its agents) that restricts the PI's rights to discuss, present or publish trial results after the trial is completed. Please contact Biosense Webster, Inc. for additional information.