A Feasibility Study to Evaluate the Effect of Concomitant... | NCT01907828

NCT01907828

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cardiac ablation + renal artery ablation	Experimental	Renal artery ablation with the EnligHTN™ Renal Denervation System	Device: Renal Artery Ablation Device: Cardiac Ablation
Cardiac ablation	Active Comparator	Cardiac ablation	Device: Cardiac Ablation

Name	Type	Description	Arm Group Labels	Other Names
Renal Artery Ablation	Device	Renal artery denervation using the EnligHTN™ Renal Denervation System	Cardiac ablation + renal artery ablation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Freedom From Atrial Fibrillation at 12 Month	The freedom from atrial fibrillation was assessed based on electrocardiographic data during nine months following the blanking period including the one week recording coinciding with the 12 month follow-up visit (9 months following the 3 month blanking period).	12 months

Secondary Outcomes

Measure	Description	Time Frame
Major Adverse Cardiac Events (MACE)	Major adverse cardiac events (MACE) were summarized as a percentage based on number of subjects at baseline for each group (RDN+AF group = 39, AF group = 22).	7 days, 6 months, 12 months, and 24 months post procedure
Percentage of Participants Who Experience Peri-procedural Events

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is ≥ 18 years of age at time of consent
Subject must be able and willing to provide written informed consent
Subject must be able and willing to comply with the required follow-up schedule
Subject is a candidate for catheter ablation for the treatment of paroxysmal or persistent atrial fibrillation as per the hospital standard of care
Subject has office Systolic Blood Pressure ≥ 140 mmHg at baseline visit
Subject has a daytime mean Systolic Ambulatory Blood Pressure > 135 mmHg within 90 days prior to procedure
Subject has established hypertension (diagnosed ≥12 month prior to baseline) and is taking >3 anti-hypertensive medications, including 1 diuretic
Subject has been on a stable unchanged anti-hypertensive medication regimen for a minimum of 4 weeks prior to the ablation procedure

Exclusion Criteria:

Subject has long standing atrial fibrillation
Subject has had a previous ablation for atrial fibrillation
Subject has had a previous renal denervation procedure
Subject has had a CABG procedure within the last 180 days (six months)
Subject has a left atrial thrombus
Subject has a contraindication to anticoagulation (i.e. heparin or warfarin)
Subject has unstable angina
Subject has had a myocardial infarction within the previous two months
Subject has a left ventricular ejection fraction (LVEF) <40% as determined by pre-procedure TTE
Subject has significant renovascular abnormalities such as renal artery stenosis > 30%
Subject has undergone prior renal angioplasty, renal denervation, indwelling renal stents, and/or abdominal aortic stent grafts
Subject has hemodynamically significant valvular heart disease as determined by study investigator
Subject has a life expectancy less than 12 months, as determined by the study investigator
Subject is participating in another clinical study which has the potential to impact his/her hypertension or atrial fibrillation management (pharmaceutical/device/homeopathic)
Subject is pregnant, nursing, or of childbearing potential and is not using adequate contraceptive methods
Subject has active systemic infection
Subject has renal arteries < 4 mm in diameter
Subject has an estimated GFR <45 mL/min per 1.73 m2 using the Modification of Diet in Renal Disease (MDRD) formula
Subject had a renal transplant or is awaiting a renal transplant
Subject has blood clotting or bleeding abnormalities
Subject has secondary arterial hypertension

Contacts/Locations Module

Name	Affiliation	Role
Christopher Piorkowski, MD	Herzzentrum Dresden GmbH Universitätsklinik	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Herzzentrum Dresden GmbH Universitätsklinik		Dresden		01307	Germany
Herzzentrum Leipzig GmbH

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36259713	Derived	Kirstein B, Tomala J, Mayer J, Ulbrich S, Wagner M, Pu L, Piorkowski J, Hankel A, Huo Y, Gaspar T, Richter U, Hindricks G, Piorkowski C. Effect of concomitant Renal DeNervation and cardiac ablation on Atrial Fibrillation recurrence - RDN+AF study. J Cardiovasc Electrophysiol. 2023 Jan;34(1):44-53. doi: 10.1111/jce.15714. Epub 2022 Dec 1.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Renal Artery Ablation + Cardiac Ablation (RDN+AF)	Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
FG001	Cardiac Ablation (AF)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Dec 4, 2014	Jul 8, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Participants treated with cardiac ablation alone.

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Renal Artery Ablation + Cardiac Ablation (RDN+AF)	Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
BG001	Cardiac Ablation (AF)	Participants treated with cardiac ablation alone.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00039 BG00122 BG00261

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

- ParticipantsBG00039
- ParticipantsBG00122
- ParticipantsBG00261

Title	Measurements

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00039 ParticipantsBG00122 ParticipantsBG002

Race and Ethnicity Not Collected

Race and Ethnicity were not collected from any participant.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG0000 ParticipantsBG0010 ParticipantsBG002

Region of Enrollment

Count of Participants

Participants

Title	Denominators	Categories
Germany	ParticipantsBG00039 ParticipantsBG00122 ParticipantsBG002

Height

Mean

Standard Deviation

Title	Denominators	Categories
	ParticipantsBG00039 ParticipantsBG00122 ParticipantsBG002

Weight

Mean

Standard Deviation

Title	Denominators	Categories
	ParticipantsBG00039 ParticipantsBG00122 ParticipantsBG002

Body mass Index (BMI)

Mean

Standard Deviation

kg/m^2

Title	Denominators	Categories
	ParticipantsBG00039 ParticipantsBG00122 ParticipantsBG002

Office Blood Pressure

Mean

Standard Deviation

mmHg

Title	Denominators	Categories
Office Systolic Blood Pressure	ParticipantsBG00039 ParticipantsBG00122 ParticipantsBG002

Office Heart Rate

Mean

Standard Deviation

beats per minute (bpm)

Title	Denominators	Categories
	ParticipantsBG00039 ParticipantsBG00122 ParticipantsBG002

Number of Participants with a history of renal assessment prior to enrollment

Renal artery imaging was performed using Computed Tomography (CT) or Magnetic Resonance (MR) angiogram within 90 days prior to enrollment. Non-contrast Magnetic Resonance Imaging (MRI) and doppler evaluation or ultrasound were also acceptable.

Renal artery evaluation data collected included but was not limited to:

Type of evaluation (CT, MR angiogram, non-contrast MRI, doppler)
Length of artery(s)
Diameter of artery(s)
Number of main renal arteries
Number of accessory renal arteries
Presence and percent of stenosis
Other abnormalities

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00039 ParticipantsBG001

New York Heart Association (NYHA) Class of Cardiac Disease

NYHA assessment was evaluated based on limitation of physical activity using the following definitions:

Class I - Patients with cardiac disease but resulting in no limitation of physical activity.

Class II- Patients with cardiac disease resulting in slight limitation of physical activity.

Class III - Patients with cardiac disease resulting in marked limitation of physical activity.

Class IV- Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort.

Class I was considered to have better outcomes and Class IV with worse outcomes.

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00039 ParticipantsBG001

Medical History

Count of Participants

Participants

Title	Denominators	Categories
Myocardial Infarction	ParticipantsBG00039 ParticipantsBG00122 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants With Freedom From Atrial Fibrillation at 12 Month

The freedom from atrial fibrillation was assessed based on electrocardiographic data during nine months following the blanking period including the one week recording coinciding with the 12 month follow-up visit (9 months following the 3 month blanking period).

Data not collected from all participants: data were available for only 28 participants in the RDN+AF group, and 12 participants in the AF group

Posted

Count of Participants

Participants

12 months

ID	Title	Description
OG000	Renal Artery Ablation + Cardiac Ablation (RDN+AF)	Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
OG001	Cardiac Ablation (AF)	Participants treated with cardiac ablation alone.

Units	Counts
Participants	OG00028 OG00112

Title

Denominators

Categories

Title	Measurements
	OG00016 OG0014

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Kaplan-Meier analysis performed to provide freedom from atrial fibrillation rates at one year for each randomization arm using date of ablation procedure to date of first event.	Log Rank		0.22														Other

Secondary

Major Adverse Cardiac Events (MACE)

Major adverse cardiac events (MACE) were summarized as a percentage based on number of subjects at baseline for each group (RDN+AF group = 39, AF group = 22).

For each group, the outcome measure was analyzed in participants randomized at baseline

Posted

Count of Participants

Participants

7 days, 6 months, 12 months, and 24 months post procedure

ID	Title	Description
OG000	Renal Artery Ablation + Cardiac Ablation (RDN+AF)	Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
OG001	Cardiac Ablation (AF)	Participants treated with cardiac ablation alone.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Who Experience Peri-procedural Events

Peri-procedural events within 30 days post procedure were summarized as a percentage based on the number of subjects at baseline for each group (RDN+AF group= 39, AF group=22)

Peri-procedural events within 30 days post procedure were summarized as a percentage based on the number of subjects at baseline for each group (RDN+AF group= 39, AF group=22).

Posted

Count of Participants

Participants

30 days post procedure

ID	Title	Description
OG000	Renal Artery Ablation + Cardiac Ablation (RDN+AF)	Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
OG001	Cardiac Ablation (AF)	Participants treated with cardiac ablation alone.

Units	Counts
Participants	OG000

Secondary

Assessment of Renovascular Safety as Measured by New Renal Artery Stenosis or Aneurysm at the Site of Ablation

Renovascular safety (new renal artery stenosis or aneurysm) was summarized as a percentage based on the number of subjects at baseline for each group (RDN+AF group= 39, AF group=22).

Posted

Count of Participants

Participants

6 months and 12 months post procedure

ID	Title	Description
OG000	Renal Artery Ablation + Cardiac Ablation (RDN+AF)	Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
OG001	Cardiac Ablation (AF)	Participants treated with cardiac ablation alone.

Units	Counts
Participants	OG000

Secondary

Renal Function Change Based on Estimated Glomerular Filtration Rate (eGFR) (Renal Denervation Group Only) at 6 Months

eGFR change from baseline was summarized based on subjects with available data at both time points (RDN+AF group = 32)

Posted

Mean

Standard Deviation

mL/min per 1.73m^2

Baseline and 6 months

ID	Title	Description
OG000	Renal Artery Ablation + Cardiac Ablation (RDN+AF)	Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.

Units	Counts
Participants	OG00032

Secondary

Renal Function Change Based on eGFR (Renal Denervation Group Only) at 12 Months

eGFR change from baseline was summarized based on subjects with available data at both time points (RDN+AF group = 33)

Posted

Mean

Standard Deviation

mL/min per 1.73m^2

Baseline and 12 months

ID	Title	Description
OG000	Renal Artery Ablation + Cardiac Ablation (RDN+AF)	Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.

Units	Counts
Participants	OG00033

Secondary

Recurrence of Atrial Fibrillation (AF) Based on Electrocardiographic Data up to 2 Years Following the Initial Cardiac Ablation Procedure.

Recurrence of AF was summarized as a percentage based on the number of subjects who underwent the procedure (RDN+AF group= 39, AF group=20)

For each group, the outcome measure was analyzed in participants who underwent the procedure (RDN+AF group= 39, AF group=20)

Posted

Count of Participants

Participants

3 months, 6 months, 12 months, 24 months

ID	Title	Description
OG000	Renal Artery Ablation + Cardiac Ablation (RDN+AF)	Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
OG001	Cardiac Ablation (AF)	Participants treated with cardiac ablation alone.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg

Posted

Count of Participants

Participants

6 months post procedure

ID	Title	Description
OG000	Renal Artery Ablation + Cardiac Ablation (RDN+AF)	Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
OG001	Cardiac Ablation (AF)	Participants treated with cardiac ablation alone.

Units	Counts
Participants	OG000

Secondary

Change in Ambulatory Blood Pressure at 12 Months

Change in Ambulatory Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 22, AF group=14)

Posted

Mean

Standard Deviation

mmHg

Baseline and 12 months post procedure

ID	Title	Description
OG000	Renal Artery Ablation + Cardiac Ablation (RDN+AF)	Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
OG001	Cardiac Ablation (AF)	Participants treated with cardiac ablation alone.

Units	Counts
Participants	OG000

Secondary

Change in Ambulatory Blood Pressure at 24 Months

Change in Ambulatory Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 17, AF group=12)

Posted

Mean

Standard Deviation

mmHg

Baseline and 24 months post procedure

ID	Title	Description
OG000	Renal Artery Ablation + Cardiac Ablation (RDN+AF)	Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
OG001	Cardiac Ablation (AF)	Participants treated with cardiac ablation alone.

Units	Counts
Participants	OG000

Secondary

Change in Office Blood Pressure at 12 Months

Change in Office Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 33, AF group=15)

Posted

Mean

Standard Deviation

mmHg

Baseline and 12 months post procedure

ID	Title	Description
OG000	Renal Artery Ablation + Cardiac Ablation (RDN+AF)	Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
OG001	Cardiac Ablation (AF)	Participants treated with cardiac ablation alone.

Units	Counts
Participants	OG000

Secondary

Change in Office Blood Pressure at 24 Months

Change in Office Blood Pressure was summarized based on subjects with available data at both time points (RDN+AF group= 29, AF group=16).

Posted

Mean

Standard Deviation

mmHg

Baseline and 24 months post procedure

ID	Title	Description
OG000	Renal Artery Ablation + Cardiac Ablation (RDN+AF)	Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.
OG001	Cardiac Ablation (AF)	Participants treated with cardiac ablation alone.

Units	Counts
Participants	OG000

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Renal Artery Ablation + Cardiac Ablation (RDN+AF)	Participants treated with renal artery ablation using the EnligHTN System and cardiac ablation.	0	39	4	39	4	39
EG001	Cardiac Ablation (AF)	Participants treated with cardiac ablation alone.	0	22	3	22	2	22

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Paroxysmal Atrial Tachycardia	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected22 at risk
Paroxysmal Atrial Fibrillation	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected22 at risk
Cardiac Arrest	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected22 at risk
Pericardial Effusion	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected22 at risk
Pericardial Tamponade	Cardiac disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected22 at risk
Hyperthyroidism	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected22 at risk
VASC Pseudoaneurysm	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected22 at risk
Renal Artery Stenosis	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected22 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hyperthyroidism	Endocrine disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected22 at risk
Hematoma	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected22 at risk
Bleeding	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0000 events0 affected39 at risk EG0011 events1 affected22 at risk
Air Embolus	Injury, poisoning and procedural complications	MedDRA 10.0	Systematic Assessment	EG0003 events3 affected39 at risk EG0010 events0 affected22 at risk
Vasospasm	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected22 at risk
VASC Pseudoaneurysm	Vascular disorders	MedDRA 10.0	Systematic Assessment	EG0001 events1 affected39 at risk EG0010 events0 affected22 at risk

ID	Term
D001281	Atrial Fibrillation
D006973	Hypertension

ID	Term
D017115	Catheter Ablation

Title

Denominators

Categories

Title	Measurements
	OG0002.2± 11.0

Title

Denominators

Categories

Title	Measurements
	OG000-0.4± 11.9

ID	Term
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D014652	Vascular Diseases

ID	Term
D000078703	Radiofrequency Ablation
D000078702	Radiofrequency Therapy
D013812	Therapeutics
D055011	Ablation Techniques
D013514	Surgical Procedures, Operative