NCT01952743

Concomitant Renal Denervation Therapy in Hypertensive Patients Undergoing Atrial Fibrillation Ablation - A Feasibility Study

Terminated NA Last updated 21 March 2017

What this trial tests

NA trial testing AF ablation with Renal Denervation in Atrial Fibrillation in 3 participants. Terminated before completion.

Timeline

1 September 2013

Primary endpoint
1 October 2014

1 October 2015

Quick facts

Lead sponsor	Siva Mulpuru
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	1 September 2013
Primary completion	1 October 2014
Estimated completion	1 October 2015
Sites	1 location across United States

Drugs / interventions tested

• AF ablation with Renal Denervation
• AF ablation alone

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →
• Hypertension — all drugs for Hypertension →

Sponsor

Siva Mulpuru

Who can join

18 and older, any sex, with Atrial Fibrillation or Hypertension. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Atrial fibrillation (AF) Time to recurrence and Burden
  Time frame: 1 year
  After 3 months of blanking period, time to recurrence of atrial arrhythmia lasting more than 30 seconds is measured during follow up. (Atrial fibrillation)AF burden is assessed on a 7 day duration event monitor. Electrocardiogram (EKG) or Event monitor strips will be evaluated by independent board certified physicians.
• Hypertension control
  Time frame: 1 year
  BP is obtained as per Joint National Committee (JNC 7) standards at 3, 6 and 12 month visits of follow up. Information regarding titration of antihypertensives or reduction in the number of medications to adequately control blood pressure is collected.

Sponsor's own description

We propose a pilot study to assess safety and benefit of renal artery ablation at the time of planned atrial fibrillation ablation.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Renal Denervation And Pulmonary Vein Isolation In Patients With Drug Resistant Hypertension And Symptomatic Atrial Fibrillation.
   Wilson S, Kistler P, McLellan AJ, Hering D, et al · · 2014 · cited 1× · PMID 27957138 · DOI 10.4022/jafib.1165
2. The Role of Renal Sympathetic Denervation in Atrial Fibrillation.
   Kosiuk Md J, Pokushalov Md Phd E, Hilbert Md S, Hindricks Md G, et al · · 2014 · cited 1× · PMID 27957040 · DOI 10.4022/jafib.987