nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation
Sponsor
Biosense Webster, Inc. (Industry)
Overall Status
Terminated
CT.gov ID
NCT01824394
Collaborator
(none)
481
48
2
55.9
10
0.2
Study Details
Study Description
Brief Summary
To demonstrate safety and effectiveness of nMARQ Catheter System [nMARQ] compared with THERMOCOOL® Navigational Family of catheters in treating subjects with drug-refractory symptomatic paroxysmal atrial fibrillation (PAF).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
481 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
reMARQable nMARQ™ Pulmonary Vein Isolation System for the Treatment of Paroxysmal Atrial Fibrillation
Actual Study Start Date
:
Apr 1, 2013
Actual Primary Completion Date
:
Nov 26, 2017
Actual Study Completion Date
:
Nov 26, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: nMARQ Catheter nMARQ Catheter System |
Device: nMARQ Navigation Catheters
|
| Active Comparator: NaviStar ThermoCool Catheters THERMOCOOL® Navigational family of catheters |
Device: NaviStar ThermoCool Catheters
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Early Onset Primary Adverse Events [30 days post-procedure]
The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs
- Incidence of Early Onset Primary Adverse Events for the Intent-to-Treat and As-Treated Population [30 days post-procedure]
The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Patients with symptomatic paroxysmal AF who have had at least one AF episode documented within one (1) year prior to enrollment. Documentation may include ECG, transtelephonic monitor (TTM), Holter monitor (HM), or telemetry strip.
-
Patients who have failed at least one antiarrhythmic drug (AAD; class I or III, or atrioventricular (AV) nodal blocking agents such as beta blockers and calcium channel blockers) as evidenced by recurrent symptomatic AF, or intolerance to the AAD.
-
Pre-procedure anticoagulation on warfarin, rivaroxaban, or apixaban.
-
Age 18 years or older.
-
Signed Patient Informed Consent Form (ICF).
-
Able and willing to comply with all pre-, post-, and follow-up testing and requirements.
Exclusion Criteria:
-
AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.
-
Previous ablation for atrial fibrillation.
-
Patients on amiodarone at any time during the past 3 months prior to enrollment.
-
AF episodes lasting > 7 days.
-
Any cardiac surgery within the past 60 days (2 months).
-
Any valvular cardiac surgical procedure (i.e., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
-
Coronary artery bypass graft (CABG) procedure within the last 180 days (6 months).
-
Awaiting cardiac transplantation or other cardiac surgery within the next 365 days (12 months).
-
Documented left atrial thrombus on imaging.
-
History of a documented thromboembolic event within the past one (1) year.
-
Diagnosed atrial myxoma.
-
Presence of implanted cardioverter defibrillator (ICD).
-
Significant pulmonary disease, (e.g., 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.
-
Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study.
-
Women who are pregnant (as evidenced by pregnancy test if subject is of child-bearing age and potential) or breast feeding.
-
Acute illness or active systemic infection or sepsis.
-
Unstable angina.
-
Myocardial infarction within the previous 60 days (2 months).
-
Left ventricular ejection fraction <40%.
-
History of blood clotting or bleeding abnormalities.
-
Contraindication to anticoagulation (i.e., heparin, dabigatran, Vitamin K Antagonists such as warfarin).
-
Life expectancy less than 365 days (12 months).
-
Enrollment in an investigational study evaluating another device or drug.
-
Uncontrolled heart failure or NYHA Class III or IV heart failure.
-
Presence of intramural thrombus, tumor or other abnormality that precludes catheter introduction or manipulation.
-
Presence of a condition that precludes vascular access.
-
Left atrial size >50 mm.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Alabama Hospital | Birmingham | Alabama | United States | 35294 |
| 2 | Arizona Heart Rhythm Center | Phoenix | Arizona | United States | 85016 |
| 3 | Good Samaritan Hospital Los Angeles | Los Angeles | California | United States | 90017 |
| 4 | Hoag Memorial Hospital Presbyterian | Newport Beach | California | United States | 92663 |
| 5 | Stanford Hospital and Clinics | Palo Alto | California | United States | 94304 |
| 6 | Sequoia Hospital | Redwood City | California | United States | 94062 |
| 7 | St. Vincent's Medical Center | Jacksonville | Florida | United States | 32204 |
| 8 | Florida Hospital Memorial Medical Center | New Smyrna Beach | Florida | United States | 32169 |
| 9 | Florida Hospital | Orlando | Florida | United States | 32803 |
| 10 | Piedmont Heart Institute | Atlanta | Georgia | United States | 30309 |
| 11 | University of Chicago | Chicago | Illinois | United States | 60637 |
| 12 | Advocate Christ Medical Center | Oak Lawn | Illinois | United States | 60453 |
| 13 | University of Kansas Hospital | Kansas City | Kansas | United States | 66160 |
| 14 | Central Baptist Hospital | Lexington | Kentucky | United States | 40503 |
| 15 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
| 16 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02215 |
| 17 | University of Michigan Health System | Ann Arbor | Michigan | United States | 48109 |
| 18 | Abbott Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
| 19 | Morristown Medical Center | Morristown | New Jersey | United States | 07960 |
| 20 | Valley Hospital | Ridgewood | New Jersey | United States | 07450 |
| 21 | Our Lady of Lourdes Medical Center | Voorhees | New Jersey | United States | 08043 |
| 22 | New York University | New York | New York | United States | 10016 |
| 23 | Mount Sinai School of Medicine, The | New York | New York | United States | 10029 |
| 24 | Duke University Medical Center | Durham | North Carolina | United States | 27705 |
| 25 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 26 | Ohio State University Medical Center, The | Columbus | Ohio | United States | 43210 |
| 27 | Oklahoma Heart Hospital | Oklahoma City | Oklahoma | United States | 73120 |
| 28 | University of Pennsylvania Health System | Philadelphia | Pennsylvania | United States | 19104 |
| 29 | Einstein Medical Center Philadelphia | Philadelphia | Pennsylvania | United States | 19141 |
| 30 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 31 | Centennial Heart | Nashville | Tennessee | United States | 37203 |
| 32 | Vanderbilt University Medical Center | Nashville | Tennessee | United States | 37232 |
| 33 | Texas Cardiac Arrhythmia Research - St. David's | Austin | Texas | United States | 78705 |
| 34 | St. Luke's Episcopal Hospital | Houston | Texas | United States | 77030 |
| 35 | The Heart Hospital Baylor Plano | Plano | Texas | United States | 75093 |
| 36 | Intermountain Medical Center | Murray | Utah | United States | 84157 |
| 37 | Virginia Commonwealth University Medical Center | Richmond | Virginia | United States | 23298 |
| 38 | Swedish Medical Center | Seattle | Washington | United States | 98122 |
| 39 | Imelda Ziekenhuis | Imeldalaan | Bonheiden | Belgium | 2820 |
| 40 | Clinique Saint-Pierre Ottignies | Ottignies | Belgium | ||
| 41 | Nemocnice Na Homolce | Prague | Czechia | 15030 | |
| 42 | Semmelweis University Heart and Vascular Center | Budapest | Városmajor U | Hungary | |
| 43 | Ospedale Generale Regionale "F. Miulli" | Acquaviva Delle Fonti | Bari | Italy | 70021 |
| 44 | Ospedale Cardinal Massaia | Asti | Italy | ||
| 45 | Centro Cardiologico Monzino | Milano | Italy | ||
| 46 | A.O.U. Città della Salute e della Scienza di Torino - Ospedale San Giovanni Battista - Molinette | Torino | Italy | ||
| 47 | Glenfield Hospital | Leicester | Leicestershire | United Kingdom | LE3 9QP |
| 48 | Freeman Hospital | Newcastle | United Kingdom |
Sponsors and Collaborators
- Biosense Webster, Inc.
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01824394
Other Study ID Numbers:
- reMARQable
First Posted:
Apr 4, 2013
Last Update Posted:
Feb 7, 2019
Last Verified:
Jan 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Biosense Webster, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | The first subject was enrolled on April 1, 2013. Enrollment was terminated on May 25, 2017. |
|---|---|
| Pre-assignment Detail | This was a prospective, multicenter, randomized, controlled, two arm single-blind design. Enrolled subjects N=481 (subjects signed informed consent) 468 does not include 13 subjects excluded prior to randomization. |
| Arm/Group Title | nMARQ® Group | ThermoCool Group | Roll-in Subjects |
|---|---|---|---|
| Arm/Group Description | Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter. | Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter. | Calibration roll-in cohort |
| Period Title: Overall Study | |||
| STARTED | 174 | 169 | 125 |
| Intent to Treat Population | 151 | 149 | 0 |
| Safety Population | 151 | 149 | 104 |
| Per-Protocol Population | 150 | 148 | 0 |
| COMPLETED | 55 | 53 | 51 |
| NOT COMPLETED | 119 | 116 | 74 |
Baseline Characteristics
| Arm/Group Title | nMARQ® Group | THERMOCOOL® Group | Roll-in Subjects | Total |
|---|---|---|---|---|
| Arm/Group Description | Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter. | Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter. | Calibration roll-in cohort | Total of all reporting groups |
| Overall Participants | 174 | 169 | 125 | 468 |
| Age (Years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [Years] |
62.0
(10.81)
|
61.8
(10.40)
|
63.6
(9.96)
|
62.4
(10.41)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
66
37.9%
|
60
35.5%
|
50
40%
|
176
37.6%
|
| Male |
108
62.1%
|
109
64.5%
|
75
60%
|
292
62.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
6
3.4%
|
3
1.8%
|
5
4%
|
14
3%
|
| Not Hispanic or Latino |
168
96.6%
|
165
97.6%
|
120
96%
|
453
96.8%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
2
1.2%
|
1
0.8%
|
3
0.6%
|
| Asian |
2
1.1%
|
0
0%
|
1
0.8%
|
3
0.6%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
2
1.1%
|
0
0%
|
0
0%
|
2
0.4%
|
| White |
169
97.1%
|
165
97.6%
|
121
96.8%
|
455
97.2%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
0.6%
|
2
1.2%
|
2
1.6%
|
5
1.1%
|
Outcome Measures
| Title | Number of Participants With Early Onset Primary Adverse Events |
|---|---|
| Description | The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs |
| Time Frame | 30 days post-procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety Population |
| Arm/Group Title | nMARQ® Group | ThermoCool Group | Roll-in Subjects |
|---|---|---|---|
| Arm/Group Description | Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter. | Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter. | Calibration roll-in cohort |
| Measure Participants | 151 | 149 | 104 |
| Count of Participants [Participants] |
8
4.6%
|
7
4.1%
|
9
7.2%
|
| Title | Incidence of Early Onset Primary Adverse Events for the Intent-to-Treat and As-Treated Population |
|---|---|
| Description | The primary safety endpoint was the incidence of early-onset primary adverse events within 7 days post the AF ablation procedure; Pulmonary vein stenosis and atrio-esophageal fistula that occurred beyond 7 days post-procedure and development of a significant pericardial effusion within 30 days post-procedure were also considered primary AEs |
| Time Frame | 30 days post-procedure |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Intent-to-Treat and As-Treated population which includes randomized patients who have the ablation catheter inserted |
| Arm/Group Title | nMARQ® Group | ThermoCool Group |
|---|---|---|
| Arm/Group Description | Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter. | Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter. |
| Measure Participants | 151 | 149 |
| Count of Participants [Participants] |
8
4.6%
|
7
4.1%
|
Adverse Events
| Time Frame | 3 years post ablation procedures | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | nMARQ® Group | THERMOCOOL® Group | Roll-in Subjects | |||
| Arm/Group Description | Pulmonary vein isolation by radiofrequency ablation treatment with the nMARQ® catheter. | Pulmonary vein isolation by radiofrequency ablation treatment with the THERMOCOOL® catheter | Calibration roll-in cohort | |||
All Cause Mortality |
||||||
| nMARQ® Group | THERMOCOOL® Group | Roll-in Subjects | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/151 (2%) | 2/149 (1.3%) | 4/104 (3.8%) | |||
Serious Adverse Events |
||||||
| nMARQ® Group | THERMOCOOL® Group | Roll-in Subjects | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 38/151 (25.2%) | 25/149 (16.8%) | 31/104 (29.8%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 1/104 (1%) | 1 |
| Chronic lymphocytic leukaemia (in remission) | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Hyperbilirubinaemia | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Cardiac disorders | ||||||
| Acute myocardial infarction | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Angina pectoris | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 1/104 (1%) | 1 |
| Arrhythmia | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Atrial fibrillation | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 4/104 (3.8%) | 5 |
| Atrial flutter | 6/151 (4%) | 11 | 2/149 (1.3%) | 2 | 2/104 (1.9%) | 3 |
| Atrioventricular block | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Bradycardia | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 2/104 (1.9%) | 2 |
| Cardiac arrest | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Cardiogenic shock | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Chest pain | 0/151 (0%) | 0 | 2/149 (1.3%) | 2 | 0/104 (0%) | 0 |
| Coronary artery disease | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Coronary artery occlusion | 0/151 (0%) | 0 | 2/149 (1.3%) | 2 | 1/104 (1%) | 1 |
| Dyspnoea | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 4/104 (3.8%) | 4 |
| Fluid overload | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Left ventricular dysfunction | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Myocardial infarction | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 2/104 (1.9%) | 2 |
| Palpitations | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 2 |
| Pericardial effusion | 3/151 (2%) | 3 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Pericarditis | 2/151 (1.3%) | 2 | 0/149 (0%) | 0 | 2/104 (1.9%) | 2 |
| Presyncope | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Pulmonary oedema | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Syncope | 2/151 (1.3%) | 2 | 1/149 (0.7%) | 1 | 1/104 (1%) | 1 |
| Tachycardia | 1/151 (0.7%) | 1 | 1/149 (0.7%) | 3 | 1/104 (1%) | 1 |
| Endocrine disorders | ||||||
| Goitre | 1/151 (0.7%) | 2 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Abdominal hernia | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Abdominal pain | 1/151 (0.7%) | 1 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Appendicitis | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Colon cancer | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Diarrhoea | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Enterocele | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Gastritis haemorrhagic | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Gastroenteritis | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Gastrointestinal haemorrhage | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Gastrooesophageal reflux disease | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Inguinal hernia | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Intestinal obstruction | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Pancreatitis acute | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Rectal cancer | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Retroperitoneal haematoma | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| General disorders | ||||||
| Chest discomfort | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Device dislocation | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 2 |
| Device related infection | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Implant site infection | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Pyrexia | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Hepatobiliary disorders | ||||||
| Cholelithiasis | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Hepatic cancer metastatic | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Immune system disorders | ||||||
| Asthma | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Infections and infestations | ||||||
| Bronchitis | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Cystitis | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Pneumonia | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 2/104 (1.9%) | 3 |
| Sepsis | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| Drug toxicity | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Hip fracture | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 2/104 (1.9%) | 2 |
| Joint dislocation | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Lumbar vertebral fracture | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Post procedural haematoma | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Postoperative fever | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Rib fracture | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Skin laceration | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Urinary retention postoperative | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Vascular pseudoaneurysm | 2/151 (1.3%) | 2 | 1/149 (0.7%) | 1 | 1/104 (1%) | 1 |
| Investigations | ||||||
| Anticoagulation drug level below therapeutic | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Blood sodium decreased | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Heart rate increased | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| International normalised ratio decreased | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 1/104 (1%) | 1 |
| International normalised ratio increased | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||
| Hyponatraemia | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Respiratory failure | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Intervertebral disc disorder | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Intervertebral disc protrusion | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 2/104 (1.9%) | 2 |
| Muscular weakness | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Musculoskeletal pain | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Osteoarthritis | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Brain neoplasm | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Ependymoma | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Lung neoplasm | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Tumour haemorrhage | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Lung neoplasm malignant | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 1/104 (1%) | 1 |
| Nervous system disorders | ||||||
| Cerebrovascular accident | 2/151 (1.3%) | 2 | 1/149 (0.7%) | 1 | 2/104 (1.9%) | 2 |
| Phrenic nerve paralysis | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Transient ischaemic attack | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 1/104 (1%) | 1 |
| Dizziness | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Gait disturbance | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Psychiatric disorders | ||||||
| Mental status changes | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Renal and urinary disorders | ||||||
| Haematuria | 1/151 (0.7%) | 2 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Reproductive system and breast disorders | ||||||
| Benign prostatic hyperplasia | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Cervical dysplasia | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Acute respiratory distress syndrome | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Chronic obstructive pulmonary disease | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Hypoxia | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Pleural effusion | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Pneumothorax | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Surgical and medical procedures | ||||||
| Cardiac pacemaker insertion | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Explorative laparotomy | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Hip arthroplasty | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Knee arthroplasty | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 2/104 (1.9%) | 2 |
| Meniscus operation | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Oesophagogastric fundoplasty | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Spinal fusion surgery | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Umbilical hernia repair | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Vascular disorders | ||||||
| Arteriovenous fistula | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Embolism | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Haematoma | 1/151 (0.7%) | 1 | 2/149 (1.3%) | 2 | 0/104 (0%) | 0 |
| Haemorrhage | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 2/104 (1.9%) | 2 |
| Vascular pseudoaneurysm | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Vessel puncture site haemorrhage | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Carotid artery stenosis | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||
| nMARQ® Group | THERMOCOOL® Group | Roll-in Subjects | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 86/151 (57%) | 86/149 (57.7%) | 74/104 (71.2%) | |||
| Blood and lymphatic system disorders | ||||||
| Anaemia | 0/151 (0%) | 0 | 3/149 (2%) | 3 | 2/104 (1.9%) | 2 |
| Cardiac disorders | ||||||
| Atrial flutter | 2/151 (1.3%) | 6 | 3/149 (2%) | 3 | 4/104 (3.8%) | 8 |
| Bradycardia | 4/151 (2.6%) | 4 | 1/149 (0.7%) | 1 | 2/104 (1.9%) | 2 |
| Chest pain | 1/151 (0.7%) | 10 | 1/149 (0.7%) | 11 | 6/104 (5.8%) | 9 |
| Dyspnoea | 3/151 (2%) | 3 | 2/149 (1.3%) | 2 | 2/104 (1.9%) | 2 |
| Fluid overload | 1/151 (0.7%) | 1 | 3/149 (2%) | 3 | 2/104 (1.9%) | 2 |
| Oedema peripheral | 2/151 (1.3%) | 3 | 2/149 (1.3%) | 3 | 2/104 (1.9%) | 2 |
| Palpitations | 1/151 (0.7%) | 1 | 2/149 (1.3%) | 2 | 2/104 (1.9%) | 2 |
| Pericardial effusion | 6/151 (4%) | 6 | 4/149 (2.7%) | 4 | 7/104 (6.7%) | 7 |
| Presyncope | 2/151 (1.3%) | 2 | 2/149 (1.3%) | 2 | 4/104 (3.8%) | 4 |
| Supraventricular tachycardia | 0/151 (0%) | 0 | 2/149 (1.3%) | 2 | 1/104 (1%) | 1 |
| Syncope | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 2/104 (1.9%) | 2 |
| Tachycardia | 5/151 (3.3%) | 5 | 4/149 (2.7%) | 4 | 5/104 (4.8%) | 6 |
| Ear and labyrinth disorders | ||||||
| Tinnitus | 0/151 (0%) | 0 | 2/149 (1.3%) | 2 | 0/104 (0%) | 0 |
| Endocrine disorders | ||||||
| Thyroid disorder | 0/151 (0%) | 0 | 2/149 (1.3%) | 2 | 0/104 (0%) | 0 |
| Eye disorders | ||||||
| Cataract | 2/151 (1.3%) | 2 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| Visual impairment | 1/151 (0.7%) | 1 | 2/149 (1.3%) | 2 | 1/104 (1%) | 1 |
| Corneal abrasionCorneal abrasion | 1/151 (0.7%) | 1 | 2/149 (1.3%) | 2 | 0/104 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Abdominal pain | 1/151 (0.7%) | 1 | 2/149 (1.3%) | 2 | 0/104 (0%) | 0 |
| Diarrhoea | 1/151 (0.7%) | 1 | 2/149 (1.3%) | 2 | 2/104 (1.9%) | 2 |
| Gastrooesophageal reflux disease | 0/151 (0%) | 0 | 2/149 (1.3%) | 2 | 1/104 (1%) | 1 |
| Nausea | 1/151 (0.7%) | 1 | 3/149 (2%) | 3 | 0/104 (0%) | 0 |
| Oesophageal injury | 2/151 (1.3%) | 2 | 1/149 (0.7%) | 1 | 0/104 (0%) | 0 |
| General disorders | ||||||
| Chest discomfort | 0/151 (0%) | 0 | 2/149 (1.3%) | 3 | 0/104 (0%) | 0 |
| Fatigue | 0/151 (0%) | 0 | 2/149 (1.3%) | 3 | 1/104 (1%) | 1 |
| Pyrexia | 2/151 (1.3%) | 2 | 4/149 (2.7%) | 4 | 1/104 (1%) | 1 |
| Vessel puncture site haematoma | 1/151 (0.7%) | 1 | 1/149 (0.7%) | 1 | 3/104 (2.9%) | 3 |
| Immune system disorders | ||||||
| Hypersensitivity | 5/151 (3.3%) | 5 | 0/149 (0%) | 0 | 2/104 (1.9%) | 2 |
| Infections and infestations | ||||||
| Bronchitis | 4/151 (2.6%) | 4 | 0/149 (0%) | 0 | 4/104 (3.8%) | 5 |
| Influenza | 0/151 (0%) | 0 | 2/149 (1.3%) | 2 | 0/104 (0%) | 0 |
| Localised infection | 3/151 (2%) | 4 | 0/149 (0%) | 0 | 1/104 (1%) | 2 |
| Pneumonia | 2/151 (1.3%) | 2 | 2/149 (1.3%) | 2 | 1/104 (1%) | 1 |
| Sinusitis | 4/151 (2.6%) | 4 | 1/149 (0.7%) | 1 | 4/104 (3.8%) | 4 |
| Urinary tract infection | 1/151 (0.7%) | 10 | 1/149 (0.7%) | 1 | 4/104 (3.8%) | 4 |
| Injury, poisoning and procedural complications | ||||||
| Arthropod bite | 0/151 (0%) | 0 | 2/149 (1.3%) | 2 | 0/104 (0%) | 0 |
| Contusion | 1/151 (0.7%) | 1 | 2/149 (1.3%) | 2 | 0/104 (0%) | 0 |
| Procedural complication | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 2/104 (1.9%) | 2 |
| Vascular pseudoaneurysm | 0/151 (0%) | 0 | 2/149 (1.3%) | 2 | 1/104 (1%) | 1 |
| Investigations | ||||||
| Heart rate increased | 0/151 (0%) | 0 | 3/149 (2%) | 3 | 0/104 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Arthralgia | 3/151 (2%) | 3 | 2/149 (1.3%) | 2 | 2/104 (1.9%) | 2 |
| Back pain | 1/151 (0.7%) | 1 | 2/149 (1.3%) | 2 | 0/104 (0%) | 0 |
| Musculoskeletal pain | 2/151 (1.3%) | 2 | 1/149 (0.7%) | 1 | 1/104 (1%) | 1 |
| Pain in extremity | 4/151 (2.6%) | 5 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Nervous system disorders | ||||||
| Dysphonia | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 2/104 (1.9%) | 2 |
| Headache | 3/151 (2%) | 4 | 0/149 (0%) | 0 | 0/104 (0%) | 0 |
| Hypoaesthesia | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 2/104 (1.9%) | 2 |
| Sleep apnoea syndrome | 5/151 (3.3%) | 5 | 2/149 (1.3%) | 2 | 4/104 (3.8%) | 4 |
| Dizziness | 0/151 (0%) | 0 | 3/149 (2%) | 3 | 1/104 (1%) | 1 |
| Renal and urinary disorders | ||||||
| Haematuria | 4/151 (2.6%) | 4 | 2/149 (1.3%) | 2 | 2/104 (1.9%) | 2 |
| Renal failure acute | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 2/104 (1.9%) | 2 |
| Urinary retention | 2/151 (1.3%) | 2 | 0/149 (0%) | 0 | 1/104 (1%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Cough | 3/151 (2%) | 3 | 2/149 (1.3%) | 2 | 1/104 (1%) | 1 |
| Pleural effusion | 2/151 (1.3%) | 2 | 1/149 (0.7%) | 1 | 1/104 (1%) | 1 |
| Vascular disorders | ||||||
| Haematoma | 1/151 (0.7%) | 11 | 7/149 (4.7%) | 7 | 1/104 (1%) | 1 |
| Haemorrhage | 1/151 (0.7%) | 1 | 2/149 (1.3%) | 2 | 0/104 (0%) | 0 |
| Hypertension | 9/151 (6%) | 10 | 8/149 (5.4%) | 9 | 7/104 (6.7%) | 8 |
| Hypotension | 2/151 (1.3%) | 2 | 2/149 (1.3%) | 2 | 1/104 (1%) | 1 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The sponsor can review results communications prior to public release and can embargo communications regarding trial results for 60 to 180 days from the time submitted to the sponsor for review. For multicenter studies, the first results communications should be a joint multicenter publication. PIs may communicate results from their institution as indicated above if a multicenter publication is not submitted by the Sponsor or representatives within 12 months of the study's conclusion.
Results Point of Contact
| Name/Title | Megan Holden |
|---|---|
| Organization | Biosense Webster, Inc. |
| Phone | (949) 923-4700 |
| mholden8@its.jnj.com |
Responsible Party:
Biosense Webster, Inc.
ClinicalTrials.gov Identifier:
NCT01824394
Other Study ID Numbers:
- reMARQable
First Posted:
Apr 4, 2013
Last Update Posted:
Feb 7, 2019
Last Verified:
Jan 1, 2019