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A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence (RDN+AF)

Primary Purpose

Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Hypertension

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Renal Artery Ablation

Cardiac Ablation

About this trial

This is an interventional treatment trial for Persistent Atrial Fibrillation

Eligibility Criteria

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

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

Sites / Locations

Herzzentrum Dresden GmbH Universitätsklinik
Herzzentrum Leipzig GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cardiac ablation + renal artery ablation

Cardiac ablation

Arm Description

Renal artery ablation with the EnligHTN™ Renal Denervation System

Cardiac ablation

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).

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)

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).

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

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

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)

Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg

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)

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)

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)

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).

Full Information

NCT ID

NCT01907828

First Posted

July 17, 2013

Last Updated

May 21, 2020

Sponsor

Abbott Medical Devices

1. Study Identification

Unique Protocol Identification Number

NCT01907828

Brief Title

A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence

Acronym

RDN+AF

Official Title

A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

April 15, 2014 (Actual)

Primary Completion Date

October 15, 2018 (Actual)

Study Completion Date

October 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abbott Medical Devices

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this post market clinical investigation is to complete preliminary evaluation on whether or not concomitant renal denervation with the EnligHTN™ Renal Denervation System and cardiac ablation will result in improved outcomes as compared to ablation alone in patients with uncontrolled hypertension being treated for Atrial Fibrillation

Detailed Description

This is a post market, prospective, multicenter, 2:1 randomized study of the EnligHTN™ Renal Denervation System in conjunction with atrial fibrillation ablation. Up to one hundred subjects with paroxysmal or persistent atrial fibrillation and uncontrolled hypertension will be enrolled in the study. All subjects will undergo cardiac ablation for the treatment of atrial fibrillation. Per the 2:1 randomization, a minimum of 50 or 2/3 of the total patient cohort will also undergo renal artery ablation. Subjects will be followed up to years (2) years post procedure.

6. Conditions and Keywords

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

Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation, Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

61 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cardiac ablation + renal artery ablation

Arm Type

Experimental

Arm Description

Renal artery ablation with the EnligHTN™ Renal Denervation System

Arm Title

Cardiac ablation

Arm Type

Active Comparator

Arm Description

Cardiac ablation

Intervention Type

Device

Intervention Name(s)

Renal Artery Ablation

Intervention Description

Renal artery denervation using the EnligHTN™ Renal Denervation System

Intervention Type

Device

Intervention Name(s)

Cardiac Ablation

Intervention Description

Safire BLU™ Duo or Therapy Cool Path Duo Irrigated Ablation Catheter or Therapy Cool Flex Irrigated Ablation Catheter EnSite Velocity System Agilis NxT Guiding Introducer

Primary Outcome Measure Information:

Title

Number of Participants With Freedom From Atrial Fibrillation at 12 Month

Description

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Major Adverse Cardiac Events (MACE)

Description

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).

Time Frame

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

Title

Percentage of Participants Who Experience Peri-procedural Events

Description

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)

Time Frame

30 days post procedure

Title

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

Description

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).

Time Frame

6 months and 12 months post procedure

Title

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

Time Frame

Baseline and 6 months

Title

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

Time Frame

Baseline and 12 months

Title

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

Description

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)

Time Frame

3 months, 6 months, 12 months, 24 months

Title

Percentage of Participants Achieving Office Systolic Blood Pressure < 140 mmHg

Time Frame

6 months post procedure

Title

Change in Ambulatory Blood Pressure at 12 Months

Description

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

Time Frame

Baseline and 12 months post procedure

Title

Change in Ambulatory Blood Pressure at 24 Months

Description

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

Time Frame

Baseline and 24 months post procedure

Title

Change in Office Blood Pressure at 12 Months

Description

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

Time Frame

Baseline and 12 months post procedure

Title

Change in Office Blood Pressure at 24 Months

Description

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

Time Frame

Baseline and 24 months post procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher Piorkowski, MD

Organizational Affiliation

Herzzentrum Dresden GmbH Universitätsklinik

Official's Role

Principal Investigator

Facility Information:

Facility Name

Herzzentrum Dresden GmbH Universitätsklinik

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Herzzentrum Leipzig GmbH

City

Leipzig

ZIP/Postal Code

04289

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Feasibility Study to Evaluate the Effect of Concomitant Renal Denervation and Cardiac Ablation on AF Recurrence

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